| CTRI Number |
CTRI/2025/01/079702 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Change in liver fat with Dapagliflozin treatment in Patients with Diabetes and Non-Alcoholic Fatty Liver Disease |
|
Scientific Title of Study
|
Effect of Dapagliflozin on Liver and Body Fat and Insulin Resistance in Patients with Type-2 Diabetes and Non-Alcoholic Fatty Liver Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bandana Dash |
| Designation |
DM Resident |
| Affiliation |
MKCGMCH |
| Address |
DM Resident,
Department of Endocrinology,Superspeciality Block- third floor,
MKCG Medical College and Hospital
Ganjam
ORISSA
760004
India |
| Phone |
7008150945 |
| Fax |
|
| Email |
doctorthesavior@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bandana Dash |
| Designation |
DM Resident |
| Affiliation |
MKCGMCH |
| Address |
DM Resident,
Department of Endocrinology,Superspeciality Block- third floor,
MKCG Medical College and Hospital
Ganjam
ORISSA
760004
India |
| Phone |
7008150945 |
| Fax |
|
| Email |
doctorthesavior@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bandana Dash |
| Designation |
DM Resident |
| Affiliation |
MKCGMCH |
| Address |
DM Resident,
Department of Endocrinology,Superspeciality Block- third floor,
MKCG Medical College and Hospital
Ganjam
ORISSA
760004
India |
| Phone |
7008150945 |
| Fax |
|
| Email |
doctorthesavior@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology, MKCG Medical Colllege and Hospital, Berhampur-760004 |
|
|
Primary Sponsor
|
| Name |
Bandana Dash |
| Address |
Room 201, Senior Residents Hostel, MKCG Medical College and Hospital, Berhampur-760004 |
| 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 P Ravi Kumar |
MKCG Medical College and Hospital |
Department of Endocrinology,Superspeciality Block- third floor,
MKCG Medical College and Hospital
Ganjam
ORISSA |
7008356202
padala797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MKCG Medical College |
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 |
Dapagliflozin |
Tablet Dapagliflozin 10mg will be given to patients once daily for 6 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be included only if they satisfy all the 3 inclusion criteria :
1-Type 2 Diabetes Mellitus patients aged more than 18 years and duration of diabetes less than 5 years.
2-Blood Glycated hemoglobin A1c(HbA1c) levels between 6.5% to 10%, on a stable dose of metformin and/or sulfonylureas over last 8 weeks.
3-Grade II or greater Fatty infiltration on abdominal ultrasound.
|
|
| ExclusionCriteria |
| Details |
1.Type 2 Diabetes Mellitus patients with poor glycemic control (Blood Glycated hemoglobin(HbA1c) more than 10%) or repeated history of Diabetic Ketoacidosis or Hyperglycemic Hyperosmolar State.
2.Patients requiring insulin due to ppor glycemic control or any serious illness.
3.Patients needing any rescue oral hypoglycemic therapy, other than metformin, sulfonylureas and dapagliflozin to achieve glycemic targets as per American Diabetes Association Guidelines.
4.Pregnant women, lactating women, women planning for pregnancy and gestational diabetes
5.Patients with estimated Glomerular Filteration rate less than 30 ml/min
6.Alcohol consumption more than 20 g per day for women or 30 g per day for men
7.Serology positive for HbSAg, HCV infection.
8.Serum ferritin more than 300ng/ml
9.Serum Ceruloplasmin less than 14ng/ml
10.Serum ANA positivity
11.Child-Pugh class B/C liver cirrhosis
12.Confounding concomitant drug use (including insulin, incretin mimetics, thiazolidinediones, vitamin E, UDCA)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on liver fat signal fraction and fibrosis scores
2.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on body fat mass and anthropometric parameters
3.To study the effect of Dapagliflozin 10 mg for 6 months, in patients of NAFLD with T2DM on HOMA-IR and Adiponectin levels
|
At baseline and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect of Dapagliflozin 10 mg in patients of Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease on HOMA-IR and serum Adiponectin levels
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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="2"
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
|
Type
2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD)
commonly coexist as part of Metabolic Syndrome, leading to significant
cardiovascular morbidity and mortality. The prevalence of NAFLD among patients
with T2DM ranges from 59-70%, and T2DM significantly increases the risk of
hepatic fibrosis and cirrhosis in these patients. Previous studies have shown
that reducing liver fat significantly improves glycemic control in patients
with T2DM. However, studies examining the effect of Dapagliflozin on liver fat
in patients with T2DM are limited and have shown heterogeneous outcomes.
Previous studies often had small sample sizes and short follow-up durations
(3-4 months). The present study will be undertaken in patients with T2DM and NAFLD
to evaluate the effect of Dapagliflozin over a period of 6 months on liver and
body fat, and markers of insulin
resistance.
|