| CTRI Number |
CTRI/2026/01/100991 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yoga on Gut Microbiota Derived Metabolites in Diabetes |
|
Scientific Title of Study
|
Effect of Yoga on Gut Microbiota Derived Metabolites in Type 2 Diabetes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shobha Vijay Kage |
| Designation |
Tutor |
| Affiliation |
KAHER JN Medical College |
| Address |
J.N Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9972290306 |
| Fax |
|
| Email |
shobhakage22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shobha Vijay Kage |
| Designation |
Tutor |
| Affiliation |
KAHER JN Medical College |
| Address |
J.N Medical College, Nehru Nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
9972290306 |
| Fax |
|
| Email |
shobhakage22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shobha Vijay Kage |
| Designation |
Tutor |
| Affiliation |
KAHER JN Medical College |
| Address |
J.N Medical College, Nehru Nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
9972290306 |
| Fax |
|
| Email |
shobhakage22@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shobha Kage |
| Address |
KAHER J.N Medical College, Nehru Nagar, Belagavi |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shobha Kage |
KLE Dr Prabhakar Kore Hospital |
J.N Medical College campus, Nehru Nagar
Belgaum
KARNATAKA |
9972290306
shobhakage22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHER Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Type 2 Diabetes Mellitus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Medication |
Standard care for type 2 DM |
| Intervention |
Medication and Yoga |
One session of orientation workshop will be done for study participants before beginning the
intervention where they will be explained in detail about study protocol.
• Supervised group yoga sessions where exercises for warm up, yoga poses involving the whole
body, pranayama and cool down will be conducted by a qualified instructor for 60 minutes/day,
on alternate days, for a period of 3 months.
• Loss of travel wages done by investigator.
• After which home exercises will be continued for the next 3 months.
The asanas performed will be – Tadasana, Utkatasana, Veerbhadrasana1 & 2, Adho Mukha Svanasana,
Bhujangasana, Kumbhakasana, Vajrasana |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 40-60 year with T2DM.
Diagnosed as Diabetic within 1 year (0-12month)
HbA1c level more than 7%
Participants willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Pregnancy
Participants with infections (acute and chronic),
Recent surgeries
Malignancy
Renal disorders and other comorbidities
Respiratory disorders
Rheumatoid arthritis
Diabetics already practicing yoga or regular physical activity, and seriously ill participants
Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Trimethylamine N -oxide(TMAO), Choline, Betaine and Carnitine – by ELISA kit
2. Blood sample is collected in blood bank around 8-10ml
3. Lipid profile
4. HbA1c |
t0 - day 0
t1 - 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
09/02/2026 |
| 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="3"
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
|
The global incidence of type 2 diabetes mellitus (T2DM) is rising, and emerging research
suggests that dysbiosis of the gut microbiota may play a significant role in the development of
the disease. Metabolites produced by gut microbiota, such as short chain fatty acids,
trimethylamine-N-oxide, tryptophan and indole derivatives, and bile acids and
lipopolysacharides, have been implicated in the pathogenesis of T2DM. These metabolites are
involved in crucial interactions between the host and microbiota, influencing disease
mechanisms. (26)
Therefore, there aren't many thorough research on the effects of yoga on gut microbiota in
diabetes. Due to this gap in information, our research aims to address this issue by examining
the gut microbe derived metabolites changes before and after yoga practice. The findings of this study will offer deeper insights into the connection between exercise and the gut microbiome, potentially highlighting targets for interventions aimed at enhancing gut and
metabolic health in patients with type 2 diabetes. |