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Effect of yoga in prevention and management of type 2 diabetes

Phase 3
Completed
Conditions
Health Condition 1: null- Type 2 Diabetes Mellitus and PreDiabetesHealth Condition 2: E119- Type 2 diabetes mellitus without complications
Registration Number
CTRI/2018/03/012804
Lead Sponsor
CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
13000
Inclusion Criteria

Inclusion Criteria for Diabetes Patients

1.Age range :20-70 years

2. Diagnosis of Type 2 Diabetes Mellitus

3. Both Genders

4. With or without Hypertension

5. With or without obesity

6. Those on oral hypo-glycaemic agents

7. Those on insulin

8. Those who can follow the yoga protocol

Inclusion Criteria for Pre Diabetes:

1. Adults between 20-70 years

2. Both genders

3. Those with scores > 50 on IDRS

4. Those with HbA1c between 5.7 and 6.4%

5. Those who consented for the study

Exclusion Criteria

Exclusion Criteria for Diabetes Patients:

1. Severe obesity (BMI >40)

2. H/o Major surgery in the past

3. H/o Tuberculosis

4. H/o Head injury, neurological or psychiatric disorder in the past

5. H/o severe, unstable myocardial ischaemia, congestive heart failure or other severe cardiac disease, severe hypertension who may be at risk when mildly increasing physical activity

6. Planning to move out of the area in the next three months.

7. Inability to exercise: Patients who are wheel chair bound, have had an amputation, are undergoing treatment for lower extremity infections, or who self-report being unable to walk 400 meters without assistance.

8. Documented cognitive impairment that would interfere with the ability to comprehend the informed consent and actively participate in the

Exclusion Criteria for Pre Diabetes:

1. H/o Major surgery in the past

2. H/o Tuberculosis

3. H/o Head injury, neurological or psychiatric disorder in the past

4. H/o severe, unstable myocardial ischemia, congestive heart failure or other severe cardiac disease, severe hypertension who may be at risk when mildly increasing physical activity

5. Those who were planning to move out of the area in the next three months.

6. Inability to exercise: Patients who were wheel chair bound, have had an amputation, are undergoing treatment for lower extremity infections, or who self-report being unable to walk 400 meters without assistance.

7. Documented cognitive impairment that would interfere with the ability to comprehend the informed consent and actively participate in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
a. Screening Data on 2.4 Lakhs Population <br/ ><br>b. Information on Prevalence of Diabetes Mellitus and Pre-diabetic individuals from randomly selected population from all states in the country and the related details of Diabetes Mellitus and pre-diabetic persons. <br/ ><br>c. Percent Conversion of pre-diabetes to Diabetes in Yoga based lifestyle.Timepoint: Variables are studied with 3 months of time.
Secondary Outcome Measures
NameTimeMethod
1.Anthropometric Profile <br/ ><br>2.Biochemical Profile <br/ ><br>3.Diet Assessment <br/ ><br>4.Stress Profile <br/ ><br>5.Quality of Life <br/ ><br>6.SleepTimepoint: Pre and Post Assessments with 3 months of time.
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