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

NCT06386939 | Recruiting

• 1 other identifier: 01/2024-2025
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 1.General Physical Examination: Height, weight, waist circumference, hip circumference, BMI, Blood Pressure, Hand grip. Acanthosis Nigricans.
2. 2.Complications Assessment: Patient will be analysed for:
3. 3.Low ABI/PAD
4. 4.CVD-MI/PTCA/CABG/Heart Failure
5. 5.CVS-Stroke/ TIA/Carotid Blockage \>50%

Conditions

Type 2 Diabetes Mellitus With Complication

Outcome Measures

Primary Outcomes (1)

• Moderate to Severe Acanthosis Nigricans increases diabetes complications

  18 months

Study Arms (2)

With Acanthosis Nigricans

T2DM with Acanthosis Nigricans

Without Acanthosis Nigricans

T2DM Without Acanthosis Nigricans

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with T2DM visiting Fortis CDOC Hospital will be enrolled in 2 groups cases and controls.

You may qualify if:

• 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

You may not qualify if:

• Alcoholic with Moderate to Severe.
• BMI \>40 kg/m²
• Congestive heart disease
• Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg. consumption of amiodarone and tamoxifen) and congestive hepatopathy.
• Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.

Sponsors & Collaborators

• Diabetes Foundation, India: lead
• National Diabetes Obesity and Cholesterol Foundation: collaborator

Study Sites (1)

Anoop misra

New Delhi, National Capital Territory of Delhi, 110048, India

RECRUITING

Study Officials

• Anoop Misra, MD

  National Diabetes Obesity and Cholesterol Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anoop Misra, MD

CONTACT

01149101222; anoopmisra@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: October 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)