To evaluate whether Yoga can delay initiation of Insulin in patients with type 2 diabetes mellitus

Not yet recruiting

• Conditions: 1.Patients with Type 2 diabetes mellitus2.HbA1c less than or equal to 8%3.On Oral drugs for diabetes with patient taking at least 2 drugs

• Registration Number: CTRI/2017/04/008370
• Lead Sponsor: ICMR

Brief Summary

The2015 update of the IDF (International Diabetes Federation) Atlas estimatesaround 69.2 million people in India to be affected by diabetes [1]. As per theUnited Kingdom Prospective Diabetes Study, 50% of pancreatic beta cells arealready lost at the time of diagnosis, with a subsequent decline of 3-5% peryear [2]. Hence, most people with type 2 diabetes (T2DM) ultimately requireinsulin therapy because of the progressive nature of their disease. Thedifficulty encountered in clinical practice relates to the acceptance ofswitching over to insulin when oral hypoglycemic agents have failed. Althoughfactors like inaccessibility (lack of personal resources) and inconveniencerelated to injection and timing of meals play an important role, ‘psychologicalresistance’ due to executive and emotional dysfunction remains an important yetignored factor [3]. Yoga is a mind/body practicebased on traditional Indian philosophy, often incorporating four majorcomponents: physical postures, breathing exercises, meditation and relaxation. Studiescomparing yoga to metabolically matched walking have shown a greaterimprovement in mood, greater decrease in anxiety and increase in levels ofthalamic gamma amino butyric acid (on brain magnetic resonance spectroscopy) inyoga asana practitioners [4]. In a systematic review on 25 randomizedcontrolled trials on 2170 participants, yoga was found to improve glycemiccontrol, lipid levels, oxidative stress, blood pressure and pulmonary andautonomic function. In addition, there was a reduced need for medication andimproved mood and sleep [5]. Hence, it would be worth studying the effect ofyoga (over and above the use of 2/3 oral hypoglycemic agents) in improvingglycemic and metabolic control, and see if a systematic yoga protocol can delayinsulin initiation in these patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-05
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age > 30 years < 70 years 2.
• Willing to adhere to protocol (Intervention, follow up, investigations, drug escalation as per protocol) 3.
• Not on Insulin 4.
• HbA1C more than or equal to 6.5 % to less than or equal to 8 5.
• On Oral drugs for diabetes with patient taking at least 2 drugs in maximal or near maximal dose as per protocol, regularly for 3 months 6.
• No physical limitation for doing Yoga for 45 minutes a day.
• Willing to do Yoga or walking at least 5 days a week.
• Willing to come for Yoga classes (13 classes in 4 months) at AIIMS.

Exclusion Criteria

1.Terminal illness 2.Known case of cancer 3.Nephropathy with CKD stage 4 and 5 4.Severe Non proliferative diabetic retinopathy, proliferative diabetic retinopathy, or macular edema 5.Any cardiovascular event requiring hospitalization in last 6 months 6.Active diabetic foot ulcer 7.Hospitalization for more than 24 hours within one month or 2 such episodes in last 6 months 8.PHQ-9 score > 14 9.Presence of suicidal thoughts for question 9 of PHQ-9 questionnaire.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. HbA1c less than or equal to 8.0% at 8 months	4, 8 and 12 months
Time to event	4, 8 and 12 months
1. HbA1c less than or equal to 8.5% at 4 months	4, 8 and 12 months
3. HbA1c less than or equal to 7.5 % at 12 months	4, 8 and 12 months
4. Increase of HbA1c by 1% as compared to baseline at any point of evaluation	4, 8 and 12 months

Secondary Outcome Measures

Name	Time	Method
Metabolic parameters: Weight and waist circumference	4,8,12 months
Psychological parameters: Depression	4 and 12 months
Cognitive functioning	12 months
Economic benefits	4 and 12 months
Problem Areas in Diabetes Score	4 and 12 months
Qualitative interview of participants receiving Yoga therapy	At end of study. 3rd Year of study

Trial Locations

Locations (2)

All India Institute of Medical Sciences, Delhi; 🇮🇳 South, DELHI, India

Madras Diabetes Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

All India Institute of Medical Sciences, Delhi

🇮🇳South, DELHI, India

Dr Yashdeep Gupta

Principal investigator

01126593237

yash_deep_gupta@yahoo.co.in