| CTRI Number |
CTRI/2026/01/102094 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Strengthening Heart Health in Type-2 Diabetes: The Role of Yoga in Preventing Cardiovascular Disease |
|
Scientific Title of Study
|
Impact of Yoga on Atherosclerotic Cardiovascular Disease Risk Reduction in Type-2 Diabetes (Yoga-AtheroCaRRe):Exploring the Protective Effects and Molecular Mechanisms |
| Trial Acronym |
YogaAtheroCaRRe |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Guru Praveen S |
| Designation |
Junior Research Fellow |
| Affiliation |
SDM college of Medical Sciences and Hospital |
| Address |
#108, 25th cross, D Block, 1st Stage, J P Nagara, Mysore SDM college of Medical Sciences and Hospital, Sattur Dharwad KARNATAKA 570031 India |
| Phone |
9740868362 |
| Fax |
|
| Email |
drgurupraveens@sdmuniversity.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Satish G Patil |
| Designation |
Professor |
| Affiliation |
SDM college of Medical Sciences and Hospital |
| Address |
SDM college of Medical Sciences and Hospital, Sattur, Dharwad. SDM college of Medical Sciences and Hospital, Sattur Dharwad KARNATAKA 580009 India |
| Phone |
9986789583 |
| Fax |
|
| Email |
satish.patil@sdmuniversity.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Guru Praveen S |
| Designation |
Junior Research Fellow |
| Affiliation |
SDM college of Medical Sciences and Hospital |
| Address |
#108, 25th cross, D Block, 1st Stage, J P Nagara, Mysore SDM college of Medical Sciences and Hospital, Sattur Dharwad KARNATAKA 570031 India |
| Phone |
9740868362 |
| Fax |
|
| Email |
drgurupraveens@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi - 110023
|
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
Ayush Bhawan, B Block, GPO Complex, INA, New Delhi - 110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 Guru Praveen S |
SDM College of Medical Sciences and Hospital |
SDM College of Medical Sciences and Hospital, Manjushree Nagar, sattur Dharwad KARNATAKA |
9740868362
gurupraveen100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Enhanced Standard care |
Enhanced standard care, comprising routine medical management
and educational materials on diabetes and cardiovascular risk management
|
| Intervention |
Integrated Yoga with Standard care |
• Integrated Yoga Program (consisting of loosening practices, Yogasanas, Pranayama & Meditation, dietary modification) along with standard treatment
• 5 days in a week for one hour daily in the morning for 3 months under the supervision of authorized yoga instructor
• In hospital sessions: weekly once
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with type 2 diabetes mellitus for at least 1 year, based on ADA criteria.
Willingness to provide informed consent and comply with trial procedures.
|
|
| ExclusionCriteria |
| Details |
Systolic blood pressure greater than or equal to 139 mmHg and or diastolic blood pressure greater than 89 mmHg, or currently on antihypertensive medication.
History of cardiovascular disease.
Presence of neuromuscular disorders or joint pain that would interfere with the ability to perform yoga.
Regular practice of yoga (defined as greater than or equal to 2–3 hours per week) within the past 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in 10-year ASCVD risk score from baseline at 12 weeks and 24 weeks following the structured yoga lifestyle intervention in individuals with T2DM |
Change in 10-year ASCVD risk score from baseline at 12 weeks and 24 weeks following the structured yoga lifestyle intervention in individuals with T2DM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immediate modulation of ASCVD-related gene expression in polymorphonuclear cells assessed after the 7-day yoga lifestyle training program. |
baseline & 8th day |
| Changes in glycemic parameters, lipid profile, & autonomic function |
baseline, 12 weeks & 24 weeks |
| Identification of molecular pathways (inflammation, oxidative stress, endothelial function) mediating the effect of yoga on ASCVD risk reduction in T2DM. |
|
| Comparative performance of validated ASCVD risk prediction tools in estimating 10-year cardiovascular risk in individuals with T2DM |
|
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
10/02/2026 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type 2 diabetes mellitus (T2DM) is associated with a markedly increased risk of atherosclerotic cardiovascular disease (ASCVD), which remains the leading cause of morbidity and mortality in this population. Despite standard pharmacological management, a substantial residual cardiovascular risk persists, highlighting the need for complementary lifestyle-based interventions. Yoga, a traditional mind–body practice, has shown benefits in improving glycemic control, lipid profile, stress, and autonomic balance; however, its impact on composite ASCVD risk and underlying molecular mechanisms in individuals with T2DM has not been adequately studied. The Yoga-AtheroCaRRe study is a prospective, randomized, open-label, blinded end-point (PROBE) trial designed to evaluate the efficacy of a structured yoga lifestyle intervention in reducing 10-year ASCVD risk in individuals with T2DM. A total of 150 participants will be randomized in a 1:1 ratio to receive either a structured yoga lifestyle program along with standard care or enhanced standard care alone. The intervention includes supervised yoga practices, breathing exercises, meditation, and lifestyle modifications. Primary outcome is the change in 10-year ASCVD risk score at 3 and 6 months using validated risk prediction tools. Secondary outcomes include changes in glycemic status, lipid profile, psychosocial stress, autonomic function, endothelial function, inflammatory and oxidative stress markers, and ASCVD-related gene expression. This study aims to generate evidence on the clinical and molecular benefits of yoga as a sustainable adjunctive strategy for cardiovascular risk reduction in T2DM. |