A study to compare the effects and benefits of drug therapy with tablet Metformin hydrochloride and change in lifestyle in the management of skin changes caused by Insulin Resistance which leads to Diabetes Mellitus.
- Conditions
- Health Condition 1: null- Insulin Resistance to prevent Diabetes Mellitus
- Registration Number
- CTRI/2012/01/002388
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
1. Subjects must have an impaired glucose tolerance suggesting that they are insulin resistant.
2. Subjects must carry a diagnosis of Acanthosis Nigricans (AN) which will be verified by a dermatologist before entering into the study. If necessary a small 4mm punch biopsy may be taken to document dermatopathology consistent with AN
3. Subjects must be willing and able to undergo treatment with metformin including initial referral and follow up.
4. Agree to abide by investigators guidelines
5. Be able to understand the requirements of the study, the risks involved and should be able to sign the informed consent form
6. Agree to follow and undergo all study related procedures
1. Subjects with Type I diabetes are excluded because of their naturally insulin deficient rather than hyper insulinemic state
2. Pregnant, planning to become pregnant or lactating women
3. Any reason the investigator feels the patient should not participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method