NCT06386939

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
Diabetes Foundation, India·ClinicalTrials.govRecruiting
View on ClinicalTrials.gov
Study focus
Study type
Observational
Sponsor & location
Primary sponsor
Diabetes Foundation, India
Location
New Delhi, India
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Nov 30, 2025
Enrollment
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 mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus with multiple complicationsType 2 diabetes mellitus without complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06386939
Type
Non-Device Trial
About this record

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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