Comparing diabetes complications in patients with and without skin changes
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
This study is testing if people with Type 2 Diabetes who have a skin condition called acanthosis nigricans face more serious diabetes complications than those who don’t have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Diabetes Foundation, India Academic / other |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT06386939 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between moderate to severe acanthosis nigricans and the severity of complications in individuals with Type 2 Diabetes Mellitus (T2DM). Patients will be recruited from an endocrine outpatient department and undergo a thorough clinical assessment, including physical examinations and evaluations for microvascular and macrovascular complications. The study seeks to determine if those with acanthosis nigricans experience a higher magnitude of diabetes-related complications compared to those without this skin condition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 20 to 70 with Type 2 Diabetes Mellitus and varying degrees of acanthosis nigricans.
Not a fit: Patients with severe obesity (BMI > 40 kg/m²), significant liver disease, or severe end organ damage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at greater risk for diabetes complications based on the presence of acanthosis nigricans.
How similar studies have performed: While the specific correlation between acanthosis nigricans and diabetes complications has not been extensively studied, similar observational studies have indicated that skin manifestations can be indicative of underlying metabolic issues.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with T2DM (up to 30 years Duration) 2. Age 20 to 70 years 3. BMI \>25 kg/m² to \>40 kg/m² 4. Gender- Both (Male \& Female) 5. Mild, Moderate and Severe Acanthosis Exclusion Criteria: 1. Alcoholic with Moderate to Severe. 2. BMI \>40 kg/m² 3. Congestive heart disease 4. Positive hepatitis B or hepatitis C, secondary causes of fatty liver (eg. consumption of amiodarone and tamoxifen) and congestive hepatopathy. 5. Severe end organ damage or chronic diseases: renal/hepatic failure, any malignancy, major systemic illness etc.
Where this trial is running
New Delhi, Delhi
- Anoop misra — New Delhi, Delhi, India (Recruiting)
Study contacts
- Principal investigator: Anoop Misra, MD — National Diabetes Obesity and Cholesterol Foundation
- Study coordinator: Anoop Misra, MD
- Email: anoopmisra@gmail.com
- Phone: 01149101222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.