Type 2 DiabetesNCT06053177
Multi-morbidity Screening in People With Type 2 Diabetes and Pre Diabetes
An observational study of Type 2 Diabetes and Pre Diabetes, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
People with type 2 diabetes are at risk of complications linked with high blood sugars and these are monitored for in healthcare appointments. However, people with type 2 diabetes commonly suffer with additional health conditions that can affect the liver, heart and their breathing while sleeping. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes, Pre Diabetes, Obstructive Sleep Apnea
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2023to 3 Feb 2028
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who are able to give their written consent and have a diagnosis of type 2 diabetes or who's latest HbA1c is ≥42mmol/mol. Who receive their medical care in the Liverpool area (UK).
Who may be able to join
- Type 2 diabetes study group
- Participants with a documented diagnosis of type 2 diabetes or HbA1c ≥48mmol/mol.
- Age ≥18 years
- Prediabetes study group
- HbA1c 42 - 47 mmol/mol (inclusive) or enrolled in the diabetes prevention programme.
- Age ≥18 years
Who cannot join
- Type 1, 3 or Maturity onset diabetes of the young.
- Participants who are pregnant at the time of screening
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Science Centre, Aintree University Hospital
Liverpool, L9 7AL
About this study
Official title: Primary Care Screening to Rapidly Detect Multi-organ Complications for People With Prediabetes and Type 2 Diabetes
People with type 2 diabetes are at risk of complications linked with high blood sugars and these are monitored for in healthcare appointments. However, people with type 2 diabetes commonly suffer with additional health conditions that can affect the liver, heart and their breathing while sleeping. These conditions are thought to be caused by a similar underlying process that causes type 2 diabetes, as a result they are very common in people type 2 diabetes. Despite this they are not part of the routine health check for these people. Worryingly, current research suggests that the risk for developing these health problems, and direct complications of type 2 diabetes, can start at blood sugar levels below the threshold of type 2 diabetes. In a group of people said to have prediabetes. These people do not currently undergo annual healthcare appointments to monitor for these health complications or other linked health conditions.
This study aims to pilot a new style of clinic to address these issues. The investigators will perform a multi-morbidity assessment, where they will look for several different health problems at the same time. The investigators will be looking at health problems linked with high blood sugars, this will include problems with the liver, heart, nerves, eyes, and participants breathing overnight. They have developed a clinic visit which uses questionnaires, simple examination techniques and modern devices to try and identify these health problems.
An important part of healthcare is the burden it places on people with health problems, with this in mind the investigators will be giving the people involved in their study a voice to try and direct future research and healthcare, the investigators will ask them to provide feedback on their experience in taking part in the study and what their thoughts are in undergoing a longer but more comprehensive health appointment.
- Conditions
- Type 2 Diabetes, Pre Diabetes, Obstructive Sleep Apnea, Non-Alcoholic Fatty Liver Disease, Heart Failure
- Keywords
- screening, multi-morbidity
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Sleep Apnea, Obstructive, Non-alcoholic Fatty Liver Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Participants with type 2 diabetes | |
| Pre Diabetes | Participants who's most recent HbA1c is in the prediabetes range. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of undiagnosed fatty liver disease with evidence of fibrosis, obstructive sleep apnoea and heart failure in people with type 2 diabetes and prediabetes
Participants will complete two screening questionnaires for sleep apnoea, those identified as high risk for the condition will be given a home sleep study device to confirm or reject the diagnosis. All participants will have a fibroscan to look for the presence of fatty liver disease. Participants will be screened for heart failure, with those identified as high risk undergoing an echocardiogram to confirm or reject the diagnosis.
Measured: The majority of the data for this outcome measure is collected in a single study visit lasting approximatley 2 and a half hours. All data for this outcome would be collected within 4 weeks of participant enrollment.
Secondary outcomes (2)
Peripheral neuropathy and cardiac autonomic dysfunction
The prevalence of peripheral neuropathy and cardiac autonomic dysfunction will be assessed using specifically designed, validated and non-invasive medical devices with results compared against outcomes of the clinical peripheral neuropathy assessments (including the MNSI, painDETECT and neuropathy symptom profile questionnaires).
Measured: The data for this outcome measure is collected in a single study visit lasting approximately 2 and a half hours.
Multi-morbidity screening
Exploration, through a questionnaire (mixture of open ended, closed and likert questions), of participants thoughts on multi-morbidity screening in high risk groups.
Measured: The data for this outcome is collected as part of the primary study visit lasting approximately 2 and a half hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start25 Jan 2023
- Primary completion3 Feb 2028 (estimated)
- Study completion3 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uazman Alam, PhD, Principal investigator, The University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053177
- Sponsor's protocol ID
- UoL001691
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Screening to Rapidly Detect Multi-organ Complications for People With Prediabetes and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06053177
- Acronym / sponsor ID
- UoL001691
- Conditions
- Type 2 Diabetes, Pre Diabetes, Obstructive Sleep Apnea, Non-Alcoholic Fatty Liver Disease, Heart Failure
- Keywords
- screening, multi-morbidity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 3 Feb 2028 (estimated)
- Study completion
- 3 Feb 2028 (estimated)
- First posted
- 25 Sep 2023 (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.
People with type 2 diabetes are at risk of complications linked with high blood sugars and these are monitored for in healthcare appointments. However, people with type 2 diabetes commonly suffer with additional health conditions that can affect the liver, heart and their breathing while sleeping. These conditions are thought to be caused by a similar underlying process that causes type 2 diabetes, as a result they are very common in people type 2 diabetes. Despite this they are not part of the routine health check for these people. Worryingly, current research suggests that the risk for developing these health problems, and direct complications of type 2 diabetes, can start at blood sugar levels below the threshold of type 2 diabetes. In a group of people said to have prediabetes. These people do not currently undergo annual healthcare appointments to monitor for these health complications or other linked health conditions.
This study aims to pilot a new style of clinic to address these issues. The investigators will perform a multi-morbidity assessment, where they will look for several different health problems at the same time. The investigators will be looking at health problems linked with high blood sugars, this will include problems with the liver, heart, nerves, eyes, and participants breathing overnight. They have developed a clinic visit which uses questionnaires, simple examination techniques and modern devices to try and identify these health problems.
An important part of healthcare is the burden it places on people with health problems, with this in mind the investigators will be giving the people involved in their study a voice to try and direct future research and healthcare, the investigators will ask them to provide feedback on their experience in taking part in the study and what their thoughts are in undergoing a longer but more comprehensive health appointment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | –Participants with type 2 diabetes |
| Pre Diabetes | – | –Participants who's most recent HbA1c is in the prediabetes range. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who are able to give their written consent and have a diagnosis of type 2 diabetes or who's latest HbA1c is ≥42mmol/mol. Who receive their medical care in the Liverpool area (UK).
Key inclusion criteria (6 listed)
- Type 2 diabetes study group
- Participants with a documented diagnosis of type 2 diabetes or HbA1c ≥48mmol/mol.
- Age ≥18 years
- Prediabetes study group
- HbA1c 42 - 47 mmol/mol (inclusive) or enrolled in the diabetes prevention programme.
Key exclusion criteria (3 listed)
- Type 1, 3 or Maturity onset diabetes of the young.
- Participants who are pregnant at the time of screening
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of undiagnosed fatty liver disease with evidence of fibrosis, obstructive sleep apnoea and heart failure in people with type 2 diabetes and prediabetes
Time frame: The majority of the data for this outcome measure is collected in a single study visit lasting approximatley 2 and a half hours. All data for this outcome would be collected within 4 weeks of participant enrollment.
Participants will complete two screening questionnaires for sleep apnoea, those identified as high risk for the condition will be given a home sleep study device to confirm or reject the diagnosis. All participants will have a fibroscan to look for the presence of fatty liver disease. Participants will be screened for heart failure, with those identified as high risk undergoing an echocardiogram to confirm or reject the diagnosis.
2 secondary outcomes
Peripheral neuropathy and cardiac autonomic dysfunction
Time frame: The data for this outcome measure is collected in a single study visit lasting approximately 2 and a half hours.
Multi-morbidity screening
Time frame: The data for this outcome is collected as part of the primary study visit lasting approximately 2 and a half hours.
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 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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. This study is not recruiting at the moment.
Uazman Alam, PhD principal investigator
The University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Pre Diabetes, run by University of Liverpool at 1 site 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of undiagnosed fatty liver disease with evidence of fibrosis, obstructive sleep apnoea and heart failure in people with type 2 diabetes and prediabetes (time frame: The majority of the data for this outcome measure is collected in a single study visit lasting approximatley 2 and a half hours. All data for this outcome would be collected within 4 weeks of participant enrollment.). 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 6 May 2026.