| CTRI Number |
CTRI/2017/01/007697 [Registered on: 13/01/2017] Trial Registered Prospectively |
| Last Modified On: |
10/10/2022 |
| 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
|
Benefit of Yoga for patients with type 2 diabetes mellitus |
|
Scientific Title of Study
|
Effects of yoga in adult patients with type 2 diabetes
mellitus: A pilot randomized control 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,Biotechnology building, Department of Endocrinology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Room No 308,Biotechnology building, Department of Endocrinology, All India Institute of Medical Sciences, Ansari Nagar, New 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,Biotechnology building, Department of Endocrinology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Room No 308,Biotechnology building, Department of Endocrinology, All India Institute of Medical Sciences, Ansari Nagar, New 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,Biotechnology building, Department of Endocrinology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
Room No 308,Biotechnology building, Department of Endocrinology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
01126593645 |
| Fax |
|
| Email |
yash_deep_gupta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology & Metabolism, AIIMS, Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Endocrinology and Metabolism AIIMS |
| Address |
Room No 308, Department of Endocrinology and Metabolism, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yashdeep Gupta |
All India Institute of Medical Sciences, New Delhi |
Seminar Room, AB 6 ward
Department of Endocrinology & Metabolism
AIIMS, New Delhi
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 diabetes with HbA1c less than 8%, Should not be on insulin. No physical limitation for Yoga or walking for 45 minutes, Age more than 30 years, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Walking |
For 45 minutes at pace of 5-6 km/hr |
| Intervention |
Yoga |
Asanas, Pranayamas and breathing modules with total of 45 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. T2DM
2. Age > 30 years
3. Follow up AIIMS Endocrinology OPD
4. Not on Insulin
5. HbA1C < 8%
6. If on OHA, than should be on stable dose of OHA for atleast
3 months.
7. No physical limitation for either doing physical activity
(brisk walking at 5-6 km/hr) of 45 minutes or Yoga for 45
minutes a day.
8. Willing to do Yoga or walking atleast 5 days a week.
9. Willing to come for Yoga classes 12 in 3 months at AIIMS |
|
| ExclusionCriteria |
| Details |
1. Not willing, and not fulfilling criteria of inclusion
2. Have history of cardiovascular disease
3. Have symptoms suggestive of cardiovascular disease
4. Have symptomatic neuropathy, severe Non proliferative
diabetic retinopathy or proliferative diabetic retinopathy
5. History of postural dizziness
6. Uncontrolled HTN BP> 140/90
7. HbA1C ≥ 8%
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PRIMARY
A. To evaluate the effect of Yoga on HbA1c and Fasting
plasma glucose
|
Baseline and at end of study i.e after 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Yoga on Lipid profile
b. To evaluate the effect of Yoga on Blood pressure
3
c. To evaluate the effect of Yoga on weight and waist
circumference
|
Baseline and at end of study i.e after 3 months
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/01/2017 |
| 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="1"
Months="6"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Suspended |
Publication Details
Modification(s)
|
The trail was suspended |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is being conducted for patients who have pre-existing diabetes (diagnosed within last 5 years), are on stable dose of oral diabetic drugs for last 3 months, have HbA1C less than 8%. The yoga studies have shown beneficial effects on multiple cardiovascular risk factors in patients with Type 2 diabetes mellitus. However, data is still too little to recommend it as an alternative to brisk walking. In case, the Yoga intervention shows beneficial effects in well planned studies, it will help patients with Type 2 diabetes mellitus to use yoga as alternative to walking. As this is a Randomized control study, therefore there are 50% chances that patient will receive yoga intervention, and 50% chances of receiving advice of 45 minutes of physical activity both for atleast 5 days in a week. The aim is To evaluate the benefit of Yoga on glycaemic control, other cardiovascular risk factors and quality of life. The primary objective is To evaluate the effect of Yoga intervention on glycaemic parameter (HbA1c and fasting plasma glucose) SECONDARY objectives are:- A. To evaluate the effect of Yoga intervention on lipid parameters. B. To evaluate the effect of Yoga intervention on blood pressure. C. To evaluate the effect of Yoga intervention on weight parameters (Weight, Waist circumference). In this study, we plan to give training for Yoga sessions (nearly 45 minutes/session), 3 sessions per week for initial 2 weeks followed by two session/week for another 2 weeks, and than one session per month for next 2 months, with a total of 12 sessions in 3 months. The patient however is advised to practice these sessions at home and do yoga atleast 5 days a week. In this study, once patient consent, he/she will be asked study specific questionnaire, undergo anthropometric measurements and blood investigations like glucose Glycosylated Hemoglobin (HbA1C), Lipid Profile. his is a 3 months study in which the investigations, assessment will be done before the start and end of study, and intervention in form of yoga sessions will be given over a period of 3 months. |