Health Condition 1: null- Insulin Resistance to prevent Diabetes Mellitus
Conditions
Interventions
Intervention1: Lifestyle modification and Tab.Metformin Hcl: 1000mg/a day, per oral for 6 months
Control Intervention1: Placebo (Tab Calcium) and Life style modification: Diet and exercise
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in severity of ANTimepoint: At the end of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in IGT 2. Improvement in Blood pressure 3. Improvement in Body mass indexTimepoint: At the end of 6 months. | — |
Countries
India
Contacts
Public ContactSandhya Venkatswami
Sri Ramachandra University
Outcome results
None listed