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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 - Trial NCT06386939

Access comprehensive clinical trial information for NCT06386939 through Pure Global AI's free database. This phase not specified trial is sponsored by Diabetes Foundation, India and is currently Recruiting. The study focuses on Type 2 Diabetes Mellitus With Complication. Target enrollment is 300 participants.

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NCT06386939
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Trial Details
ClinicalTrials.gov โ€ข NCT06386939
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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
Comparison of Micro- and Macrovascular Disease(s) in People With Type 2 Diabetes, Who Have Moderate to Severe Acanthosis Nigricans vs. Those Who do Not Have Acanthosis Nigricans

Study Focus

Observational

Sponsor & Location

Diabetes Foundation, India

New Delhi, India

Timeline & Enrollment

N/A

May 01, 2024

Nov 30, 2025

300 participants

Primary Outcome

Moderate to Severe Acanthosis Nigricans increases diabetes complications

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%

ICD-10 Classifications

Type 2 diabetes mellitus
Type 2 diabetes mellitus with unspecified complications
Type 2 diabetes mellitus with other specified complications
Type 2 diabetes mellitus with multiple complications
Type 2 diabetes mellitus without complications

Data Source

ClinicalTrials.gov

NCT06386939

Non-Device Trial