Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe… (NCT06386939) | Clinical Trial Compass
UnknownNot Applicable
Comparison of Micro- and Macrovascular Disease(s) in People With T2D, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans
India300 participantsStarted 2024-05-01
Plain-language summary
Hypothesis: Moderate to severe acanthosis nigricans in people with T2D is associated with higher magnitude of complication than people who do not have acanthosis nigricans.
Objectives: To correlate moderate to severe acanthosis nigricans with diabetes complication
Methodology:
T2DM patient will be recruited from endocrine OPD
1\. Clinical History and Examination:
1. General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Acanthosis Nigricans.
2. Complications Assessment: Patient will be analysed for:
Micro Vascular
(a) Diabetic retinopathy (i) Mild NPDR (ii) Mod NPDR (iii) Macular Edema / CSME (b) Neuropathy (Mild/Mod/Severe) (c) Chronic Kidney Disease (i) Micro/Macro albumin urea (ii) Increased Creatinine (iii) Decreased eGFR
Macro Vascular
1. Low ABI/PAD
2. CVD-MI/PTCA/CABG/Heart Failure
3. CVS-Stroke/ TIA/Carotid Blockage \>50%
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with T2DM (up to 30 years Duration)
. Age 20 to 70 years
. BMI \>25 kg/m² to \>40 kg/m²
. Gender- Both (Male \& Female)
. Mild, Moderate and Severe Acanthosis
Exclusion criteria
. Alcoholic with Moderate to Severe.
. BMI \>40 kg/m²
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Moderate to Severe Acanthosis Nigricans increases diabetes complications