Diabetes Mellitus, Type 2NCT06439719
Plaque Composition in T2DM With and Without Microvascular Complications
An observational study of Diabetes Mellitus, Type 2, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
Adults with diabetes mellitus have 2-3 times fold increased cardiovascular (CV) risk compared to adults without diabetes, and the risk rises with the worsening of glycaemic control. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Blood sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 244 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2024to 27 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice. They will be, therefore, divided into two groups: * Group A: subjects with T2DM with at least one DMC * Group B: subjects with T2DM without DMCs
Who may be able to join
- Informed consent signed before any activity related to the study
- Age 40 - 70 years, both sexes
- Diagnosis of T2DM ≥5 years
- CT coronary imaging performed in 60 days before enrollment
Who cannot join
- Previous diagnosis of type 1 diabetes, late autoimmune diabetes of the adults (LADA), diabetes secondary to pancreatitis
- Malignant disease
- Acute/chronic inflammatory disease
- Severe obesity
About this study
Official title: Differences in Plaque Composition Evaluated Through Coronary Tomography in Subjects With Type 2 Diabetes With and Without Microvascular Complications
Adults with diabetes mellitus have 2-3 times fold increased cardiovascular (CV) risk compared to adults without diabetes, and the risk rises with the worsening of glycaemic control. Adults with type 2 diabetes mellitus (T2DM) and microvascular complications (DMCs) have a higher risk of CV complications than subjects without DMCs. 2023 European Society of Cardiology (ESC) guidelines stated that individuals with T2DM with target organ damage (TOD), defined as presence of microvascular disease in at least three different sites (e.g., microalbuminuria (stage A2) plus retinopathy plus neuropathy), should be considered into a very high CV risk category.
Coronary artery calcium score (CACS) is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging. CACS has become a widely available and accurate tool for determining the risk of major CV events.
Read more
The specific role of DMCs in determining the features of coronary plaques is not completely known. A recent study showed how T2DM subjects with obstructive coronary artery disease (CAD) with DMCs at their first coronary event present a more "stable" coronary atherosclerosis features at OCT-imaging, as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs. In this study only subjects with obstructive CAD (defined as a stenosis ≥50% in the left main coronary artery or any stenosis ≥70% or fractional flow reserve <0.80 in any other major epicardial vessel) were enrolled.
Therefore, further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required.
Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs, focusing on the degree of plaque calcification calculated by the CACS.
Read the detailed description
Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice.
They will be, therefore, divided into two groups:
- Group A: subjects with T2DM with at least one DMC, as defined:
- Retinopathy, defined as any diabetes related eye disease (macular oedema, severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy) or previous history of retinal photocoagulation therapy and/or intravitreal injections of anti- vascular endothelial growth factor (VEGF) agents.
- Neuropathy, including any diabetes-related neurological complication (diabetic peripheral neuropathy, diabetic autonomic neuropathy).
- Nephropathy, defined as the presence of albuminuria (urinary albumin > 30 mg/g creatinine) and/or an estimated glomerular filtration rate < 60 mL/min/1.73 m2
- Group B: subjects with T2DM without DMCs.
Following data will be collected Anthropometric parameters
- Sex
- Year of birth
- Height, expressed in m
- Weight, expressed in Kg
- BMI, calculated as weight divided by height squared
Vital signs
- Blood pressure, expressed in mmHg;
- Heart rate, expressed in bpm;
- VFA (Visceral fat area - cm2);
- SFA (subcutaneous fat area - cm2).
Medical history
- Date of diagnosis of diabetes, at least the year;
- Comorbidities;
- Year of diagnosis of comorbidities.
- Smoking habits, defined as "current smoker", "former smoker", "never smoked"
Medications
- Diabetes medications;
- Dose of each diabetes medications;
- Year of start for each diabetes medications;
- Concomitant medications;
- Dose of each concomitant medications;
- Year of start for each concomitant medication.
Cardiovascular risk scores
- SCORE2-Diabetes [12]
Blood Tests data collection
- HbA1c
- Serum Creatinine
- Total Cholesterol
- LDL Cholesterol
- HDL Cholesterol
- Triglycerides
- Transaminases
- Microalbuminuria
Blood sample collection • CRP
Cardiovascular Autonomic Tests
Following Cardiovascular autonomic tests will be performed:
- Deep breathing: The patient sits quietly and breathes deeply at six breaths a minute (five seconds in and five seconds out) for one minute. An electrocardiogram is recorded throughout the period of deep breathing, with a marker used to indicate the onset of each inspiration and expiration.
- Valsalva manoeuvre: The test is performed by the patient blowing into a mouth- piece connected to an aneroid manometer or a modified sphygmomanometer and holding it at a pressure of 40 mm Hg for 15 seconds while a continuous electrocardiogram is recorded. The manoeuvre is performed three times with one- minute intervals between.
- Lying to standing: The test is performed by measuring the patient's blood pressure with a sphygmomanometer while he is lying down quietly and again when he stands up. The postural fall in blood pressure is taken as the difference between the systolic blood pressure lying and the systolic blood pressure standing [13].
Neuropathy evaluation
- Michigan Neuropathy Screening Instrument (MNSI-Q) questionnaire [14]
- COMPASS31 questionnaire [15]
- Diabetic Neuropathy Index (DNI) questionnaire [16]
- DN4 questionnaire [17]
- Monofilament examination
Ophthalmologic evaluation
- Non mydriatic Ocular fundus photography
Coronary CTA parameters collection
- Total EAT
- EAT of atrio_ventricular sulcus
- EAT of anterior interventricular artery, both as volume and thickness
- EAT of right coronary artery
- EAT of circumfl ex coronary artery
- EAT Volume Index (cm3/m2)
- Perivascular FAI (-30 -190 UH)
- CACS (Agatston score, Volume and mass)
- Plaque grading/stenosis (Minimum, mild, intermediate, Severe), using CAD-RADS 2.0
- Plaque characteristics non-calcific, mixed and calcific plaque, evaluating any high-risk plaque profile
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Blood sample collection
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionProcedure or surgery
Collection of blood sample
| Study group | Role | What they receive |
|---|---|---|
| T2DM with microvascular complications | T2DM with microvascular complications Receives: Procedure: Blood sample collection | |
| T2DM without microvascular complications | T2DM without microvascular complications Receives: Procedure: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery calcium score
Differences in coronary calcium score between subjects with diabetes with and with our microvascular complications
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start27 May 2024 (estimated)
- Primary completion27 May 2026 (estimated)
- Study completion27 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439719
- Sponsor's protocol ID
- 6561
- Status last verified
- May 2024
- First submitted
- 28 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Plaque Composition Evaluated Through Coronary Tomography in Subjects With Type 2 Diabetes With and Without Microvascular Complications
- ClinicalTrials.gov ID
- NCT06439719
- Acronym / sponsor ID
- 6561
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 27 May 2024 (estimated)
- Primary completion
- 27 May 2026 (estimated)
- Study completion
- 27 May 2026 (estimated)
- First posted
- 3 Jun 2024 (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.
Adults with diabetes mellitus have 2-3 times fold increased cardiovascular (CV) risk compared to adults without diabetes, and the risk rises with the worsening of glycaemic control. Adults with type 2 diabetes mellitus (T2DM) and microvascular complications (DMCs) have a higher risk of CV complications than subjects without DMCs. 2023 European Society of Cardiology (ESC) guidelines stated that individuals with T2DM with target organ damage (TOD), defined as presence of microvascular disease in at least three different sites (e.g., microalbuminuria (stage A2) plus retinopathy plus neuropathy), should be considered into a very high CV risk category.
Coronary artery calcium score (CACS) is a measure of the amount of calcium deposits in the coronary arteries obtained through a CT coronary imaging. CACS has become a widely available and accurate tool for determining the risk of major CV events.
The specific role of DMCs in determining the features of coronary plaques is not completely known. A recent study showed how T2DM subjects with obstructive coronary artery disease (CAD) with DMCs at their first coronary event present a more "stable" coronary atherosclerosis features at OCT-imaging, as they have a higher prevalence of fibrous plaques and healed plaques with larger calcifications compared to those with T2DM and no DMCs. In this study only subjects with obstructive CAD (defined as a stenosis ≥50% in the left main coronary artery or any stenosis ≥70% or fractional flow reserve <0.80 in any other major epicardial vessel) were enrolled.
Therefore, further research to evaluate differences in CACS in T2DM subjects with no previous history of CAD with and without DMCs is required.
Aim of our study was to evaluate the presence of differences in the distribution and tomographic features of coronary plaques in T2DM subjects with no previous history of CAD with at least one DMCs, focusing on the degree of plaque calcification calculated by the CACS.
Detailed description
Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice.
They will be, therefore, divided into two groups:
- Group A: subjects with T2DM with at least one DMC, as defined:
- Retinopathy, defined as any diabetes related eye disease (macular oedema, severe non proliferative diabetic retinopathy, proliferative diabetic retinopathy) or previous history of retinal photocoagulation therapy and/or intravitreal injections of anti- vascular endothelial growth factor (VEGF) agents.
- Neuropathy, including any diabetes-related neurological complication (diabetic peripheral neuropathy, diabetic autonomic neuropathy).
- Nephropathy, defined as the presence of albuminuria (urinary albumin > 30 mg/g creatinine) and/or an estimated glomerular filtration rate < 60 mL/min/1.73 m2
- Group B: subjects with T2DM without DMCs.
Following data will be collected Anthropometric parameters
- Sex
- Year of birth
- Height, expressed in m
- Weight, expressed in Kg
- BMI, calculated as weight divided by height squared
Vital signs
- Blood pressure, expressed in mmHg;
- Heart rate, expressed in bpm;
- VFA (Visceral fat area - cm2);
- SFA (subcutaneous fat area - cm2).
Medical history
- Date of diagnosis of diabetes, at least the year;
- Comorbidities;
- Year of diagnosis of comorbidities.
- Smoking habits, defined as "current smoker", "former smoker", "never smoked"
Medications
- Diabetes medications;
- Dose of each diabetes medications;
- Year of start for each diabetes medications;
- Concomitant medications;
- Dose of each concomitant medications;
- Year of start for each concomitant medication.
Cardiovascular risk scores
- SCORE2-Diabetes [12]
Blood Tests data collection
- HbA1c
- Serum Creatinine
- Total Cholesterol
- LDL Cholesterol
- HDL Cholesterol
- Triglycerides
- Transaminases
- Microalbuminuria
Blood sample collection • CRP
Cardiovascular Autonomic Tests
Following Cardiovascular autonomic tests will be performed:
- Deep breathing: The patient sits quietly and breathes deeply at six breaths a minute (five seconds in and five seconds out) for one minute. An electrocardiogram is recorded throughout the period of deep breathing, with a marker used to indicate the onset of each inspiration and expiration.
- Valsalva manoeuvre: The test is performed by the patient blowing into a mouth- piece connected to an aneroid manometer or a modified sphygmomanometer and holding it at a pressure of 40 mm Hg for 15 seconds while a continuous electrocardiogram is recorded. The manoeuvre is performed three times with one- minute intervals between.
- Lying to standing: The test is performed by measuring the patient's blood pressure with a sphygmomanometer while he is lying down quietly and again when he stands up. The postural fall in blood pressure is taken as the difference between the systolic blood pressure lying and the systolic blood pressure standing [13].
Neuropathy evaluation
- Michigan Neuropathy Screening Instrument (MNSI-Q) questionnaire [14]
- COMPASS31 questionnaire [15]
- Diabetic Neuropathy Index (DNI) questionnaire [16]
- DN4 questionnaire [17]
- Monofilament examination
Ophthalmologic evaluation
- Non mydriatic Ocular fundus photography
Coronary CTA parameters collection
- Total EAT
- EAT of atrio_ventricular sulcus
- EAT of anterior interventricular artery, both as volume and thickness
- EAT of right coronary artery
- EAT of circumfl ex coronary artery
- EAT Volume Index (cm3/m2)
- Perivascular FAI (-30 -190 UH)
- CACS (Agatston score, Volume and mass)
- Plaque grading/stenosis (Minimum, mild, intermediate, Severe), using CAD-RADS 2.0
- Plaque characteristics non-calcific, mixed and calcific plaque, evaluating any high-risk plaque profile
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM with microvascular complications | – | Procedure: Blood sample collectionT2DM with microvascular complications |
| T2DM without microvascular complications | – | Procedure: Blood sample collectionT2DM without microvascular complications |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with T2DM who performed CT coronary imaging, as per clinical routine practice. They will be, therefore, divided into two groups: * Group A: subjects with T2DM with at least one DMC * Group B: subjects with T2DM without DMCs
Key inclusion criteria (4 listed)
- Informed consent signed before any activity related to the study
- Age 40 - 70 years, both sexes
- Diagnosis of T2DM ≥5 years
- CT coronary imaging performed in 60 days before enrollment
Key exclusion criteria (4 listed)
- Previous diagnosis of type 1 diabetes, late autoimmune diabetes of the adults (LADA), diabetes secondary to pancreatitis
- Malignant disease
- Acute/chronic inflammatory disease
- Severe obesity
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 |
|---|---|---|
| Blood sample collectionCollection of blood sample | Procedure or surgery | T2DM with microvascular complications, T2DM without microvascular complications |
Primary outcome
Coronary artery calcium score
Time frame: 24 months
Differences in coronary calcium score between subjects with diabetes with and with our microvascular complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Coronary artery calcium score (time frame: 24 months). 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 3 Jun 2024.