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Benefit of Yoga for patients with type 2 diabetes mellitus

Suspended
Conditions
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
Registration Number
CTRI/2017/01/007697
Lead Sponsor
Department of Endocrinology and Metabolism AIIMS
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
All
Target Recruitment
80
Inclusion Criteria
  • Age > 30 years 3.
  • Follow up AIIMS Endocrinology OPD 4.
  • Not on Insulin 5.
  • If on OHA, than should be on stable dose of OHA for atleast 3 months.
  • 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.
  • Willing to do Yoga or walking atleast 5 days a week.
  • Willing to come for Yoga classes 12 in 3 months at AIIMS.
Exclusion Criteria
  • 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PRIMARYBaseline and at end of study i.e after 3 months
A. To evaluate the effect of Yoga on HbA1c and FastingBaseline and at end of study i.e after 3 months
plasma glucoseBaseline and at end of study i.e after 3 months
Secondary Outcome Measures
NameTimeMethod
To evaluate the effect of Yoga on Lipid profileb. To evaluate the effect of Yoga on Blood pressure

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi

🇮🇳

Delhi, DELHI, India

All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr Yashdeep Gupta
Principal investigator
01126593645
yash_deep_gupta@yahoo.co.in

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