A randomized controlled trial to study the effects of one year Yoga intervention in patients with Type 2 Diabetes

Completed

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/02/017750

Lead Sponsor: Swami Vivekananda Yoga Anusandhana Samsthana SVYASA University

Brief Summary: This study is Randomized, parallel group, active controlled trial comparing the effects of Yoga based lifestyle (Yoga module for T2DM developed by Ministry of AYUSH, Government of India, 1 hour per day/ 5 days a week + Counseling on yoga based lifestyle, once a week for initial 4 weeks) and physical exercise (brisk walk for 45 minutes followed by 15 minutes rest per day, 5 days a week + Health education, once a week for initial 4 weeks) for one year in 176 patients with type 2 diabetes mellitus. The study will be conducted in Bangalore, India. The primary outcome of the study will be HbA1c level. The secondary outcomes will be other biochemical levels (FBS, PPBS), clinical symptoms, Electro-photonic Imaging parameters, and Thermal Imaging parameters.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 176

Inclusion Criteria

Subjects with the diagnosis of type 2 diabetes Subjects suffering from T2DM for maximum of 10 years Either with or without medications Subjects the MMSE (Mini Mental Status Examination) score above 24 Those willing to participate in the study Those who can write, read and understand the English.

Exclusion Criteria

Those with uncontrolled T2DM Those with Chronic Kidney disease Those with Visual difficulties or k/c/o diabetic retinopathy Those with established coronary artery disease or past history of heart disease Those with h/o stroke or other major neurological disorders Subjects with other metabolic disorders like hypothyroidism or hyperthyroidism Those with severe psychiatric disorders Those with h/o practicing Yoga regularly (at least once a week for one month or more) in the last 1 year If the control group also follows some form of Yoga on regular basis during the period of study (at least once a week for one month or more), then they will be excluded from the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of 1 year Yoga based lifestyle intervention on HbA1c level of T2DM patients	at baseline after 6 months and after 1 year of intervention

Secondary Outcome Measures

Name	Time	Method
To assess the effect of 1 year Yoga based lifestyle intervention on clinical symptoms of T2DM patients	at baseline after 6 months and after 1 year of intervention
To assess the effect of 1 year Yoga based lifestyle intervention on other biochemical levels (FBS, PPBS) of T2DM patients	at baseline after 6 months and after 1 year of intervention
To assess the effect of 1 year Yoga based lifestyle intervention on Electro-photonic Imaging parameters of T2DM patients	at baseline after 6 months and after 1 year of intervention
To assess the effect of 1 year Yoga based lifestyle intervention on Thermal Imaging parameters of T2DM patients	at baseline after 6 months and after 1 year of intervention

Trial Locations

Locations (2): Govindâ€™s Medical and Diabetes Centre
🇮🇳
Bangalore, KARNATAKA, India
Samatvam Endocrinology Diabetes Center
🇮🇳
Bangalore, KARNATAKA, India
Govindâ€™s Medical and Diabetes Centre
🇮🇳Bangalore, KARNATAKA, India
Dr Hemant Bhargav
Principal investigator
08026995730
hemant.bhargav1@gmail.com