Type2 DiabetesUKIDSNCT05057403
UK Imaging Diabetes Study Seeing Diabetes Clearly
An observational study of Type2 Diabetes, run by Perspectum at 12 sites in United Kingdom.
Trial summary
Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 5 years, in adult patients with type 2 diabetes lacking… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- MRI
- How many people
- 1,000 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 30 May 2022to Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants, aged 18 years of age and over with type 2 diabetes lacking history of cardiovascular disease. Recruitment will be carried out from patients identified following diabetes or diabetic retinopathy diagnoses or via self-referral. 1. Diabetes referral appointments 2. Diabetic retinopathy referral appointments 3. Primary care and diabetes clinics - including GP practices 4. Participant Identification Centres 5. Diabetes Eye Screening Programmes (DESP)
Who may be able to join
- Male or female at least 18 years of age and diagnosed with type 2 diabetes, with or without diabetic retinopathy.
- Participant willing and able to give informed consent for participation in the study.
Who cannot join
- In 12 months prior to consent, evidence of existing cardiovascular event defined as at least one of:
- myocardial infarction
- ischaemic stroke
- hospital admission/discharge for unstable angina
- heart surgery
- unstable angina
Show all 11Show fewer
- transient ischemic attack
- The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
- Patients with known autoimmune hepatitis, viral hepatitis, Wilson's disease or known significant structural renal tract abnormality.
- Patients with known alcohol dependency.
- Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United Kingdom12 sites, 12 recruiting
- Not yet recruiting
Swansea Bay University Health Board
Baglan, Swansea, SA12 7BR
Rebeccah Thomas, 0044 1792530819, rebeccah.thomas2@wales.nhs.uk
- Recruiting
Woodlands Medical Centre
Didcot, Oxfordshire, OX11 0BB
Cheryl Heng, 0044 1235517760, cherylheng@nhs.net
- Recruiting
Eynsham Medical Centre
Eynsham, Oxfordshire, OX29 4QB
Aarushi Kethrapal, 0044 1865 881206, aarushi.kheterpal@nhs.net
- Recruiting
White Horse Medical Practice
Farringdon, Oxfordshire, SN7 7YU
Jill Larkin, 0044 1367242963, jill.larkin@nhs.net
- Recruiting
University Hospitals of Liverpool Group
Liverpool, L9 7AL
Tanya Ingram, 0044 151 5294778, TANYA.INGRAM@liverpoolft.nhs.uk
- Enrolling by invitation
Moorfields Eye Hospital NHS Foundation Trust
London
- Recruiting
The Manor Group
Oxford, OX3 9BP
Michelle Carter, 0044 1865 922963, michelle.carter32@nhs.net
- Recruiting
Hedena Health
Oxford, OX3 9JA
Nicholas Groom, 00441865 966995, nicholas.groom@nhs.net
- Recruiting
St Bartholomew and Hollow Way Medical Practice
Oxford, OX4 1XB
Clare Murray, 0044 1865 244435, clare.murray42@nhs.net
- Recruiting
Oxford Community Diagnostic centre
Oxford, OX42LL
Elizabeth Bennett, 00441865 655343, elizabeth.bennett@perspectum.com
- Recruiting
The House Partnership
Redhill, Surrey, RH1 1EB
Thanosan Jeevaratnam, 0044 1737642207, thanosan.jeevaratnam2@nhs.net
- Recruiting
Windrush Medical Practice
Witney, Oxfordshire, OX26 6JS
Eleanor Jones, 0044 1993 862157, eleanor.jones69@nhs.net
About this study
Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 5 years, in adult patients with type 2 diabetes lacking history of cardiovascular disease.
Read the detailed description
This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 5 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multi-organ, multiparametric MRI scan. Both visits will be within 28 days of the screening visit and carried out at local study sites.
MRI metrics of organ health, clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Participants will be asked to give consent for access to their medical records held at NHS England and, if available, at their local GP surgery or hospital. Medical records access will include Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics and provided by NHS England to meet the primary objective. This data will be collected at 1, 3 and 5 years after baseline assessment.
- Conditions
- Type2 Diabetes
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
MRI is not part of Pathway for patient with type two diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Patients with type 2 diabetes, especially individuals who have been diagnosed in the last three years Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline liver MR metrics on incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) in people with type 2 diabetes, without history of CV.
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on cardiovascular clinical outcomes in a patient population with type 2 diabetes without history of cardiovascular disease.
Measured: 3 year from baseline
Secondary outcomes (107)
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
Measured: 5 years from baseline
Prevalence of patients with evidence of metabolic dysfunction-associated steatotic liver disease in patients with diabetic retinopathy of different severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR)
The co-prevalence of diabetic retinopathy (DR) and metabolic dysfunction-associated steatotic liver disease (MASLD), using multi-parametric abdominal MRI
Measured: 1 year from baseline
Correlations between liver MRI metrics (organ volume, fat infiltration and fibroinflammation) and eye metrics (retinal layer thickness by OCT, discrete retinopathy scores)
The correlation between severity of eye disease and MRI-derived metrics of liver disease using multiparametric MRI
Measured: 1 year from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start30 May 2022
- Primary completionJun 2034 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Moorfields Eye Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ravi Pattanshetty, Principal investigator, Perspectum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057403
- Sponsor's protocol ID
- 20/WM/0007
- Acronym
- UKIDS
- Status last verified
- Nov 2025
- First submitted
- 1 Sep 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK Imaging Diabetes Study Seeing Diabetes Clearly
- ClinicalTrials.gov ID
- NCT05057403
- Acronym / sponsor ID
- UKIDS / 20/WM/0007
- Conditions
- Type2 Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Collaborators
- Moorfields Eye Hospital NHS Foundation Trust
- Study start
- 30 May 2022 (actual)
- Primary completion
- Jun 2034 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 5 years, in adult patients with type 2 diabetes lacking history of cardiovascular disease.
Detailed description
This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 5 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multi-organ, multiparametric MRI scan. Both visits will be within 28 days of the screening visit and carried out at local study sites.
MRI metrics of organ health, clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Participants will be asked to give consent for access to their medical records held at NHS England and, if available, at their local GP surgery or hospital. Medical records access will include Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics and provided by NHS England to meet the primary objective. This data will be collected at 1, 3 and 5 years after baseline assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | Other: MRIPatients with type 2 diabetes, especially individuals who have been diagnosed in the last three years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants, aged 18 years of age and over with type 2 diabetes lacking history of cardiovascular disease. Recruitment will be carried out from patients identified following diabetes or diabetic retinopathy diagnoses or via self-referral. 1. Diabetes referral appointments 2. Diabetic retinopathy referral appointments 3. Primary care and diabetes clinics - including GP practices 4. Participant Identification Centres 5. Diabetes Eye Screening Programmes (DESP)
Key inclusion criteria (2 listed)
- Male or female at least 18 years of age and diagnosed with type 2 diabetes, with or without diabetic retinopathy.
- Participant willing and able to give informed consent for participation in the study.
Key exclusion criteria (11 listed)
- In 12 months prior to consent, evidence of existing cardiovascular event defined as at least one of:
- myocardial infarction
- ischaemic stroke
- hospital admission/discharge for unstable angina
- heart surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI is not part of Pathway for patient with type two diabetes. | Other | Type 2 diabetes |
Primary outcome
Baseline liver MR metrics on incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) in people with type 2 diabetes, without history of CV.
Time frame: 3 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on cardiovascular clinical outcomes in a patient population with type 2 diabetes without history of cardiovascular disease.
107 secondary outcomes
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
Time frame: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time frame: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time frame: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
Time frame: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
Time frame: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time frame: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time frame: 5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
Time frame: 1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
Time frame: 3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
Time frame: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
Time frame: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
Time frame: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
Time frame: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
Time frame: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
Time frame: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
Time frame: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
Time frame: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
Time frame: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
Time frame: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time frame: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time frame: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time frame: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
Time frame: 1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
Time frame: 3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
Time frame: 5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality
Time frame: 1 year from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ravi Pattanshetty principal investigator
Perspectum
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes, run by Perspectum at 12 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soubera Rymall, MSc (00447919272482, soubera.rymell@perspectum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline liver MR metrics on incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) in people with type 2 diabetes, without history of CV. (time frame: 3 year from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.