A multicentric, randomized, controlled trial of yoga and fenugreek in prevention of type 2 diabetes mellitus: methodological details —the Indian Prevention of Diabetes Study (IPDS)

AbstractPreliminary studies have shown that yoga as well as fenugreek are beneficial in patients with type 2 diabetes mellitus (T2DM). This clinical trial is the first of its kind to prospectively evaluate in a multicentric, randomized, and controlled design if yoga and fenugreek can prevent the composite outcome of T2DM in prediabetic individuals. It aims to investigate whether there is an effective and safe treatment modality for the prevention of T2DMwhich is also-cost effective and can be implemented easily on a large scale so as to reduce the burden of T2DM. One thousand five hundred obese prediabetic individual aged 30 –70 years were proposed to be identified on the basis of a 75-g oral glucose tolerance test (OGTT) and randomized to one of the three intervention arms viz standard life style measures + placebo (n = 500), standard life style measures + placebo + yoga (n = 500), and Standard life style measures + fenugreek (n = 500). Yoga consisted of a 40-min session each day which included yoga asanas and pranayamas. Fenugreek was given as fenugreek powder. All subjects were followed on an outpatient basis for 3 years, and annual OGTTs were done to pick up incident cases of diabetes mellitus. Incident rates, time to event analysis, and hazard ratios were compared between the groups. Secondary outcomes studied were change in glycemia, quality of life, cardiovascular disease and cardiovascular risk factors, beta cell function (HOMA-B), insu...
Source: International Journal of Diabetes in Developing Countries - Category: Endocrinology Source Type: research