FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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. 

 
Close