CTRI Number |
CTRI/2017/04/008370 [Registered on: 19/04/2017] Trial Registered Prospectively |
Last Modified On: |
21/03/2017 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
To evaluate whether Yoga can delay initiation of Insulin in patients with type 2 diabetes mellitus |
Scientific Title of Study
|
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. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Yashdeep Gupta |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, New Delhi |
Address |
Room No 308, Biotechnology building, AIIMS, Ansari Nagar, New Delhi
South DELHI 110029 India |
Phone |
01126593237 |
Fax |
|
Email |
yash_deep_gupta@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Yashdeep Gupta |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, New Delhi |
Address |
Room No 308, Biotechnology building, AIIMS, Ansari Nagar, New Delhi
South DELHI 110029 India |
Phone |
01126593237 |
Fax |
|
Email |
yash_deep_gupta@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Yashdeep Gupta |
Designation |
Assistant Professor |
Affiliation |
All India Institute of Medical Sciences, New Delhi |
Address |
Room No 308, Biotechnology building, AIIMS, Ansari Nagar, New Delhi
South DELHI 110029 India |
Phone |
01126593237 |
Fax |
|
Email |
yash_deep_gupta@yahoo.co.in |
|
Source of Monetary or Material Support
|
Indian Council of Medical Research. Ansari Nagar New Delhi - 110029. |
|
Primary Sponsor
|
Name |
ICMR |
Address |
ICMR, Near AIIMS, South Delhi |
Type of Sponsor |
Government funding agency |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Yashdeep Gupta |
All India Institute of Medical Sciences, Delhi |
Room No 308, Biotechnology building, 3rd Floor, AIIMS, Ansari Nagar, 110029 South DELHI |
01126593237
yash_deep_gupta@yahoo.co.in |
Dr RM Anjana |
Madras Diabetes Research Foundation |
No 4 Conran Smith Road, Gopalapuram, Chennai 600 086, Tamilnadu, India Chennai TAMIL NADU |
04443968888 04428350935 dranjana@drmohans.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Ethics Committee |
Approved |
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Submittted/Under Review |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
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 , |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Walking |
Walking at speed of 5-6 km/hr for 30 minutes |
Intervention |
Yoga |
An integrated module of 45 minutes of specific Asanas, Kriyas, breathing exercises and meditation |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
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.
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
|
|
ExclusionCriteria |
Details |
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
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
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
|
4, 8 and 12 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Metabolic parameters: Weight and waist circumference |
4,8,12 months |
Psychological parameters: Depression |
4 and 12 months |
Problem Areas in Diabetes Score |
4 and 12 months |
Cognitive functioning |
12 months |
Economic benefits |
4 and 12 months |
Qualitative interview of participants receiving Yoga therapy |
At end of study. 3rd Year of study |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/05/2017 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The
2015 update of the IDF (International Diabetes Federation) Atlas estimates
around 69.2 million people in India to be affected by diabetes [1]. As per the
United Kingdom Prospective Diabetes Study, 50% of pancreatic beta cells are
already lost at the time of diagnosis, with a subsequent decline of 3-5% per
year [2]. Hence, most people with type 2 diabetes (T2DM) ultimately require
insulin therapy because of the progressive nature of their disease. The
difficulty encountered in clinical practice relates to the acceptance of
switching over to insulin when oral hypoglycemic agents have failed. Although
factors like inaccessibility (lack of personal resources) and inconvenience
related to injection and timing of meals play an important role, ‘psychological
resistance’ due to executive and emotional dysfunction remains an important yet
ignored factor [3]. Yoga is a mind/body practice
based on traditional Indian philosophy, often incorporating four major
components: physical postures, breathing exercises, meditation and relaxation. Studies
comparing yoga to metabolically matched walking have shown a greater
improvement in mood, greater decrease in anxiety and increase in levels of
thalamic gamma amino butyric acid (on brain magnetic resonance spectroscopy) in
yoga asana practitioners [4]. In a systematic review on 25 randomized
controlled trials on 2170 participants, yoga was found to improve glycemic
control, lipid levels, oxidative stress, blood pressure and pulmonary and
autonomic function. In addition, there was a reduced need for medication and
improved mood and sleep [5]. Hence, it would be worth studying the effect of
yoga (over and above the use of 2/3 oral hypoglycemic agents) in improving
glycemic and metabolic control, and see if a systematic yoga protocol can delay
insulin initiation in these patients. |