Effect of yoga intervention on skeletal muscle linked glucose homeostasis in pre-diabetic individuals: Study protocol for a randomized controlled trial

Background- The pre-diabetic stage is important in terms of identification and timely management, as it is reversible. Along with other factors, insulin resistance in skeletal muscle is often considered as primary defect before development of overt hyperglycemia and diabetes. Proven to have many health benefits, Yoga has emerged as an effective measure in management of diabetes. As the Yogic postures are relatable to exercises, it was considered for improving skeletal muscle function and reverse the pre-diabetic stage.Methods- The present open, randomized clinical study is planned to evaluate the effect of Yoga interventions on muscle mass, strength, endurance and flexibility which are direct or indirect indicators of fat deposition in skeletal muscles. The study will also explore association between changes in muscle quality/ functionality and glycemic control. With Ethics committee permission, 120 pre-diabetic individuals of either sex between the age group of 35-49 years with a BMI in the range of 25-35 kg/m2 and family history of T2DM will be recruited in study after obtaining written informed consent. They will be randomly allocated to either Yoga or exercise group by computer generated randomized method in a 1:1 ratio. One group will receive defined Yoga interventions, while other group will receive fixed program of physical exercises. Both groups will undergo a training session for a period of 4 weeks under the supervision of a trained instructor, before 12-week study duration. The outcome measures will be parameters related to muscle quality/functionality and glucose metabolism markers. Discussion- Our study aims to study usefulness of Yoga in prediabetic stage on skeletal muscle related glycemic control, which is novel. In addition, the study will generate awareness about pre-diabetes and provide people with active coping skills for reversing it. Trial Registration- Clinical Trial Registry-India -CTRI/2019/05/019149, registered on: 15/05/2019