1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sathupatil@yahoo.co.in].
   


6. For how long will this data be available start date provided 01-12-2027 and end date provided 01-12-2037?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

OBJECTIVES OF THE STUDY

Primary Objective: To determine if yoga practice improves endothelial function and prevent or improves atherosclerosis in individuals with type-2 diabetes.

Secondary objectives: (1) To determine the preventive effects of yoga on early vascular aging and vascular complications in individuals with type-2 diabetes. (2) To compare the effects of different components of yoga (Yogasanas, pranayama, meditation) on vascular system in patients with type-2 diabetes. (3) To determine the underlying mechanism of yoga on vascular health and diabetes.

METHODOLOGY

Study population, design & protocol: A four-arm, parallel-treatment, prospective randomized open blinded end-point (PROBE) study will be conducted on a total of 248 (62 in each arm) patients with type-2 diabetes mellitus (T2DM) with age ranging between 30-65 years. Volunteers will be screened at Visit 1-3 during which glycemic status, three consecutive BP recordings (on three consecutive days) and clinical history will be taken. At visit 4, baseline investigation followed by randomization and allocation of subjects to either intervention arms (study groups) or control arm will be done. Post-intervention investigation will be made at Visit 5. Persons handling data analysis will be kept blinded (single blinded).

Selection criteria: Patients aged between 30-65 years with T2DM will be included for the study. Diabetes subjects with atherosclerosis are also eligible for the study. Subjects with SBP ˃ 139 mmHg and DBP ˃ 89, subjects with any CV disease and other significant diseases (other than atherosclerosis) or clinically significant abnormal laboratory values during screening will be excluded from the study.

Randomization: The eligible subjects will be allocated for either intervention arms or control arm using the computer generated random number.

Intervention:

Arm-1: Study group-1 (n=62)-Subjects of this group will practice Yogasanas (with dietary modification) for one hour/day for 5 days in a week for 3 months under the supervision of trained yoga instructor, along with their standard care.

Arm-2: Study group-2 (n=62)-Subjects of this group will practice Pranayama and Meditation (with dietary modification) for one hour/day for 5 days in a week for 3 months under the supervision of trained yoga instructor, along with their standard care.

Arm-3: Study group-3 (n=62)-Subjects of this group will practice integrated yoga (Yogasanas, pranayama, meditation and dietary modification) for one hour/day for 5 days in a week for 3 months under the supervision of trained yoga instructor, along with their standard care.

Arm-4: Control group (n=62)-Subjects of this group will receive only standard care.

Outcomes of the study

Primary outcomes   : Changes in the atherosclerosis markers and endothelial function

Secondary outcomes: Changes in the vascular aging markers, autonomic function, cardiovascular hemodynamics, oxidative stress and inflammatory markers.

Data analysis: Data will be presented as mean ± SD with confidence intervals. Level of significance: Statistical significance will be established at p< 0.05. Mean difference with confidence intervals will be calculated. Distribution of data will be verified. Difference between four groups will be analyzed using ANNOVA. Paired-t test will be applied to find the difference within group, if the data is uniformly distributed. Non-parametric test will be used to analyze non-uniform data. Analysis of Covariance (ANCOVA) will be applied to find the differences in the post-intervention values between study and control groups while controlling the pre-test values.

Summary of the proposed research