| CTRI Number |
CTRI/2025/09/094365 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Diet and Exercise intervention ] |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Effect of Diet and Exercise Intervention on Sarcopenic Obesity in Diabetic Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) |
|
Scientific Title of Study
|
Effect of Diet and Exercise Intervention on Sarcopenic Obesity in Diabetic Patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Prospective Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritu Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Mahatma Gandhi University of Medical Science & Technology |
| Address |
Department of Clinical Nutrition and Dietetics, Mahatma Gandhi Institute of Allied Health Sciences, Mahatma Gandhi University of Medical Science & Technology, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7895751539 |
| Fax |
|
| Email |
ritujasyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vineeta Bansal |
| Designation |
Professor and Head |
| Affiliation |
Mahatma Gandhi University of Medical Science & Technology |
| Address |
Department of Clinical Nutrition and Dietetics, Mahatma Gandhi Institute of Allied Health Sciences, Mahatma Gandhi University of Medical Science & Technology, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9784637324 |
| Fax |
|
| Email |
drvineetabansal@mgumst.com |
|
Details of Contact Person
Public Query
|
| Name |
Ritu Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Mahatma Gandhi University of Medical Science & Technology |
| Address |
Department of Clinical Nutrition and Dietetics, Mahatma Gandhi Institute of Allied Health Sciences, Mahatma Gandhi University of Medical Science & Technology, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7895751539 |
| Fax |
|
| Email |
ritujasyadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute of Allied Health Sciences, Mahatma Gandhi University of Medical Science & Technology Jaipur Rajasthan 302022 |
|
|
Primary Sponsor
|
| Name |
Ritu Yadav |
| Address |
Department of Clinical Nutrition and Dietetics Mahatma Gandhi Institute of Allied Health Sciences, Mahatma Gandhi University of Medical Science & Technology Jaipur Rajasthan |
| Type of Sponsor |
Other [Self] |
|
|
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 Vineeta Bansal |
Department of Clinical Nutrition and Dietetics, Mahatma Gandhi Institute of Allied Health Sciences |
Dietician OPD, Dharmashala Building Ground Floor, Mahatma Gandhi Hospital, MGUMST Jaipur
Jaipur
RAJASTHAN |
9784637324
drvineetabansal@mgumst.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Mahatma Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z682||Body mass index (BMI) 20-29, adult, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diet and Exercise Intervention |
Group I (Control group) will include sarcopenic obesity in diabetic patients with MASLD, treated with a tailored dietary regime.
Group II (Study group) will include sarcopenic obesity in diabetic patients with MASLD, treated with a tailored dietary regime AND a tailored exercise regime
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diabetic patients who have sarcopenic obesity with metabolic dysfunction-associated steatotic liver disease (MASLD).
2. can provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Compensated and decompensated liver cirrhosis.
2. Large Esophageal Varices.
3. HCC or any other malignancy
4. Poor cardiopulmonary reserve or other advanced systemic disease (other than diabetes mellitus) with expected survival less than 1 year.
5. Patient on the Use of semaglutide T2DM drugs known to induce weight loss (GLP-1 agonists like semaglutide, GLP1-A +GIP-A like Trizepatide)
6. Organ failure.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sarcopenia and weight loss |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion achieving
1. Improvement in sarcopenia
2. Target body weight
3. Maintaining Target body weight till end of study
4. Optimal glycemic control
5. Reduction in liver fat content
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/09/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Two groups will be made according to the inclusion and exclusion criteria Group I (Control group) will be treated with a tailored dietary regime (a standard of care) Group II (Study group) will be treated with a tailored dietary regime AND a tailored exercise regime Interventions will be given for 24 weeks and follow-up will be taken till 52 weeks The baseline data will be recorded and compared with intervention outcomes so that effect of Diet and Exercise Intervention can be measured in both groups Data will be analyzed with an appropriate statistical tool.
|