To study the effect of Yoga on glucose and mental health
- Conditions
- Health Condition 1: null- Diabetes with mild to moderate depression (PHQ 9 score from 5 to 14)
- Registration Number
- CTRI/2017/09/009812
- Lead Sponsor
- Applied for funding to Department of Science and Technology Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of Yoga on depression in patients with T2DMTimepoint: At 4 months
- Secondary Outcome Measures
Name Time Method To evaluate the effect of Yoga on anxiety in patients with T2DMTimepoint: At 4 and 8 months;To evaluate the effect of Yoga on cognitive functions in patients with T2DMTimepoint: At 4 and 8 months;To evaluate the effect of Yoga on depression in patients with T2DMTimepoint: At 8 months;To evaluate the effect of Yoga on diabetes related distress in patients with T2DMTimepoint: At 4 and 8 months;To evaluate the effect of Yoga on glycemic control in patients with T2DMTimepoint: 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 profileTimepoint: At 4 and 8 months