None listed
Conditions
Interventions
Intervention1: Selenium: capsules containing 100mcg of selenium to be given twice daily
Duration: 24 months
Control Intervention1: Placebo: Empty capsules of same color and appearance given twice dai
Sponsors
Research Society for Study of Diabetes in India West Bengal Chapter
Eligibility
Inclusion criteria
Inclusion criteria: Individuals with persistent impaired fasting glucose (IFG) (100-125mg/dl) and/or impaired glucose tolerance (IGT) (140-199mg/dl) over 2 oral glucose tolerance tests (OGTTS) done over a week using 75 gram anhydrous glucose were included
Exclusion criteria
Exclusion criteria: Subjects with diabetes mellitus are excluded, i.e. FPG >= 126 mg/dl or 2-hour plasma glucose >= 200 mg/dl during OGTT, Hyperthyroid patients Medical conditions likely to limit life span and/or increase risk of intervention Cardiovascular disease Hospitalization for treatment of heart disease or stroke in past 6 months New York Heart Association Functional Class > 2 Renal disease (creatinine >= 1.6 mg/dl for men or >= 1.5 mg/dl for women Hepatitis, based on history and/or serum ALT greater than 2.5 times the upper limit of normal Recent or significant abdominal surgery Pulmonary disease with dependence on oxygen or daily use of bronchodilators Chronic infection (e.g., HIV, active tuberculosis) Patients with history of selenium supplementation Pregnancy and childbearing Currently pregnant or within 3 months postpartum Currently nursing or within 6 weeks of having completed nursing Medications and medical conditions likely to confound the assessment for diabetes, including Thiazide diuretics at a dose greater than 25 mg/day Non-cardioselective beta-blockers, systemic Niacin (individuals receiving treatment with a statin or fenofibrate will not be excluded as long as the dose has been stable for 3 months prior to randomization) Glucocorticoids, systemic Prescription weight-loss or weight-gain medications
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Primary
| Measure | Time frame |
|---|---|
| Progression to diabetes (fasting blood glucose125mg/dl or 2h post glucose blood glucose199mg/dl) Reversal to normoglycemia (fasting blood glucose100mg/dl and 2h post glucose blood glucose 140mg/dl)Timepoint: Outcomes assessed every 3 months during follow up | — |
Countries
India
Contacts
Public ContactManoj Kumar
IPGMER and SSKM Hospital
Outcome results
None listed