| CTRI Number |
CTRI/2025/03/082592 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
This study observes how Dapagliflozin affects body composition in people with Type 2 Diabetes who are not well-controlled on Metformin at SMS hospital Jaipur. |
|
Scientific Title of Study
|
A prospective observational study on effect of dapagliflozin on body composition In type 2 diabetes mellitus patients inadequately controlled with metformin at SMS hospital, jaipur during 2024-2026. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavya Raj |
| Designation |
Postgraduate Resident |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of pharmacology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India (302004)
Jaipur
RAJASTHAN
302004
India |
| Phone |
9072206374 |
| Fax |
|
| Email |
bhavyaraj480@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Charu Jain |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of pharmacology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India (302004)
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829269332 |
| Fax |
|
| Email |
jaincharujaincharu2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Charu Jain |
| Designation |
Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Department of pharmacology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India (302004)
Jaipur
RAJASTHAN
302004
India |
| Phone |
9829269332 |
| Fax |
|
| Email |
jaincharujaincharu2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMS medical college and hospital, jaipur, Rajasthan, India (302004) |
|
|
Primary Sponsor
|
| Name |
Bhavya Raj |
| Address |
Department of Pharmacology, SMS medical College, Jaipur, Rajasthan, India (302004) |
| 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 Bhavya Raj |
Sawai Man Singh Hospital |
Outpatient department, Department of Endocrinology, Sawai Man Singh Hospital
Jaipur
RAJASTHAN |
9072206374
bhavyaraj480@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, SMS Medical college and attached hospitals, jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients of more than 18 years and of either sex whose HbA1C levels are more than 7.5 after at least 3 months of treatment with metformin.
2. Patients giving consent for the study. |
|
| ExclusionCriteria |
| Details |
1. Patients whose BMI less than 20 and BMI more than 35 (morbid obese)
2. Patients with any other comorbidities like dyslipidemia, hypertension, cardiac disorders etc.
3. Patients with evidence of micro or macrovascular complications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The proportion of patients on dapagliflozin showing reduction in total body fat ,total body lean mass, total body fat percentage using DEXA Scan.
2. The proportion of patients showing changes in VAT and SAT Score using MRI
3. The proportion of patients showing changes in physical parameters like BMI, body weight and waist circumference |
1. 0 month.
2. 3 months.
3. 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The proportion of patients showing improvement in glycemic control using HbA1C and FBG in the study population.
2. The proportion of patients showing improvement on insulin resistance by monitoring adiponectin level. |
1. 0 month.
2. 3 months.
3. 6 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
02/04/2025 |
| 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)
|
Not Applicable |
| 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
|
Adipose tissue contributes to insulin resistance through inflammatory mechanisms, highlighting the importance of managing body composition in type 2 diabetes mellitus (T2DM). Key risk factors for T2DM include obesity, high-caloric diets, and sedentary lifestyles, which have led to a global increase in the disease. While many drugs improve the quality of life for T2DM patients, addressing adiposity is crucial for effective treatment. This study will give us a better understanding about the effect of dapagliflozin on body composition in T2DM patients inadequately controlled on metformin. |