Relation between body selenium, insulin resistance and systemic inflammation in prediabetes and role of selenium supplementation in prevention of diabetes
- Registration Number
- CTRI/2014/01/004319
- Lead Sponsor
- Research Society for Study of Diabetes in India West Bengal Chapter
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression to diabetes (fasting blood glucose125mg/dl or 2h post glucose blood glucose199mg/dl) <br/ ><br> <br/ ><br>Reversal to normoglycemia (fasting blood glucose100mg/dl and 2h post glucose blood glucose 140mg/dl)Timepoint: Outcomes assessed every 3 months during follow up
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI