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CTRI Number  CTRI/2017/09/009812 [Registered on: 18/09/2017] Trial Registered Prospectively
Last Modified On: 16/09/2017
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 study the effect of Yoga on glucose and mental health  
Scientific Title of Study   Effect of Yoga on psychological, cognitive and glycemic control in patients with T2DM and Depression: Two arm parallel Randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yashdeep Gupta 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 308, Endocrine office, 3rd Floor, Biotechnology building, AIIMS, Ansari Nagar, Delhi

New Delhi
DELHI
110029
India 
Phone  01126593645  
Fax    
Email  yash_deep_gupta@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Yashdeep Gupta 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 308, Endocrine office, 3rd Floor, Biotechnology building, AIIMS, Ansari Nagar, Delhi

New Delhi
DELHI
110029
India 
Phone  01126593645  
Fax    
Email  yash_deep_gupta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Yashdeep Gupta 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room No 308, Endocrine office, 3rd Floor, Biotechnology building, AIIMS, Ansari Nagar, Delhi

New Delhi
DELHI
110029
India 
Phone  01126593645  
Fax    
Email  yash_deep_gupta@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Science & Technology, Technology Bhavan, New Mehrauli Road,, New Delhi-110 016. 
 
Primary Sponsor  
Name  Applied for funding to Department of Science and Technology Delhi 
Address  Applied for funding to Department of Science and Technology, 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 = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
YASHDEEP GUPTA  All India Institute of Medical Sciences, New Delhi  Department of Endocrinology and Metabolism, Seminar Room, AB-6 ward, Ansari Nagar
New Delhi
DELHI 		 01126593645

yash_deep_gupta@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diabetes with mild to moderate depression (PHQ 9 score from 5 to 14),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Usual Care   Diet and activity advice of 30 minutes 
Intervention  Yoga for 45 minutes  An integrated module has been made using specific Asanas, Kriyas, breathing exercises and meditation as to target depressive symptoms and glycemic control. The physical activity component of yoga module (Asanas/Kriyas) are designed separately for those who have no limitation to physical activity and for those who have such limitation. The yoga sessions will be given by trained certified yoga therapists supervised by Assistant Professor and Acharya from S-VYASA, Bengaluru.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 Type 2 diabetes
2 Age > 30 years
3 Willing to come for Yoga sessions/study visits in AIIMS as per module
4 On basis of HbA1c depending upon type of therapy
a) ≥ 7.5% to ≤ 9% if only on oral drugs ± basal insulin
b) ≥ 7.5% to ≤ 10 %, if on premix insulin for ≥ 6 months, and glycemic status has not been successfully optimized despite on regular follow up of recruiting clinic for atleast 6 months and 4 clinical visits
c) ≥ 7.5% to any degree of hyperglycemia, if on multiple dose insulin for ≥ 6 months and glycemic status has not been successfully optimized, despite on regular follow up of recruiting clinic for atleast 6 months and 4 clinical visits

5 Eligibility on basis of patient health questionnaire-9 (PHQ-9)Patients with mild to moderate depression (PHQ-9 score from 5-14) are eligible. Details of PHQ-9 are given ahead.

 
 
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 Any death of first degree relative in last 6 months
9 PHQ-9 score < 5 or > 14
10 Suicidal thoughts nearly everyday i.e score of 3 for question 9 of PHQ-9 questionnaire
11 Patients with dementia (Montreal cognitive assessment or MOCA score < 19
 
 
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 
To evaluate the effect of Yoga on depression in patients with T2DM   At 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effect of Yoga on depression in patients with T2DM   At 8 months 
To evaluate the effect of Yoga on anxiety in patients with T2DM   At 4 and 8 months 
To evaluate the effect of Yoga on diabetes related distress in patients with T2DM   At 4 and 8 months 
To evaluate the effect of Yoga on cognitive functions in patients with T2DM   At 4 and 8 months 
To evaluate the effect of Yoga on glycemic control in patients with T2DM  At 4 and 8 months 
To evaluate the effect of Yoga on other cardiovascular risk factors like weight, body mass index, blood pressure and lipid profile  At 4 and 8 months 
 
Target Sample Size   Total Sample Size="320"
Sample Size from India="320" 
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)   01/01/2018 
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 study will assess effect of yoga and meditation on depression, anxiety, diabetes related distress, cognitive deficits, glycemic control and metabolic risk factors in patients with Type 2 diabetes who have comorbid depression at baseline. The study is a randomized controlled trial with parallel arm comparator [prescription of 30 minutes of walking]. The study has been powered to 90% to detect even 10% difference in depression scores between the two arms. The study has a component of intervention phase of 4 months in which yoga will be taught and supervised by Yoga therapists and a component of sustainability phase, in which the patients will have no further supervised yoga sessions. Since, this study is pragmatic in nature, we will see whether there is benefit of yoga on multiple domains in diabetes after intervention phase. The aim of sustainability phase will evaluate whether the effects can be sustained after supervision is over. The end of 8 months evaluation will help in knowing the medium term effects of yoga. 

The current study will do comprehensive assessment of cognitive deficits by psychological tests. This sort of comprehensive work has never been done before globally. 

The broader aim of this study is to have deeper understanding of  yoga in Type 2 diabetes, and then subsequently try to see yoga as first choice or alternative to physical activity for these patients, which may help in better managing their diabetes, enhance their work related performance and inter-personal interactions. 

 
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