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

A pilot multicentre open label parallel arm RCT evaluating whether yoga can delay initiation of insulin therapy in patients with type 2 diabetes mellitus with suboptimal glycemic control on near maximal oral drugs and/or who may require insulin therapy in near future.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/04/008370
Enrollment
300
Registered
2017-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- 1. Patients with Type 2 diabetes mellitus 2. HbA1c less than or equal to 8% 3. On Oral drugs for diabetes with patient taking at least 2 drugs

Interventions

Intervention1: Yoga: An integrated module of 45 minutes of specific Asanas, Kriyas, breathing exercises and meditation Control Intervention1: Walking: Walking at speed of 5-6 km/hr for 30 minutes

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age > 30 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. 7. Willing to do Yoga or walking at least 5 days a week. 8. Willing to come for Yoga classes (13 classes in 4 months) at AIIMS

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Problem Areas in Diabetes ScoreTimepoint: 4 and 12 months;Psychological parameters: DepressionTimepoint: 4 and 12 months;Qualitative interview of participants receiving Yoga therapyTimepoint: At end of study. 3rd Year of study;Cognitive functioningTimepoint: 12 months;Economic benefitsTimepoint: 4 and 12 months;Metabolic parameters: Weight and waist circumferenceTimepoint: 4,8,12 months—

Countries

India

Contacts

Public ContactDr Yashdeep Gupta

All India Institute of Medical Sciences, New Delhi

yash_deep_gupta@yahoo.co.in01126593237

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026