None listed
Conditions
Interventions
Intervention1: Intensive Life style modification,Metformin: Intensive Life style modification will be administered for 6 months to one of the 3 arms of the study group. The goals for the intensive lif
Sponsors
Division of Clinical Trials St Johns Research Institute Bangalore
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria:diagnosis of prediabetes as per ADA 2011 guidelines - defined as fasting plasma glucose (FPG) of 100-125 mg/dl as impaired fasting glucose (IFG) or - 2-h plasma glucose in the 75-g OGTT (oral glucose tolerance test) of 140-199 mg/dl as impaired glucose tolerance ( IGT) or - glycosylated haemoglobin ( Hb A1C of 5.7-6.4% ). Any two values will be used.
Exclusion criteria
Exclusion criteria: Patients with history or clinical symptoms of cardiovascular disease Previously on oral hypoglycemic agents Patients having other medical conditions like Cushingâ??s disease or acromegaly. Patients currently on steroids or acutely ill. Inability to participate in physical activities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction in hsCRP levels in each of the 3 study arms. Timepoint: At the end of 6 months from the time of last study subject recruited. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction or non progression of carotid IMT in each of the 3 study arms and 2. Proportion of subjects developing diabetes or cardiovascular events during the study period Timepoint: At the end of 6 months | — |
Countries
India
Contacts
Public ContactDr Shruthi Kulkarni
St.Johns National Academy of Health Sciences
Outcome results
None listed