Drug trial between Dapagliflozin with existing drug Saroglitazar in patients with Non alcoholic fatty liver disease and diabetes

Not Applicable

Not yet recruiting

Conditions: Hepatic fibrosis,

Registration Number: CTRI/2023/12/060736

Lead Sponsor: Deepthi v

Brief Summary: NAFLD has become a major cause of chronic liver disease and is treated as public health priority. NAFLD is often observed in patients with type 2 DM and NAFLD. Therapeutic options for management of NAFLD are limited and include lifestyle modifications, antioxidants and insulin sensitizers. Saroglitazar is a dual peroxisome proliferator activated receptors activator. Saroglitazar is the first drug approved in India for management of diabetic dyslipedemia. Dapagliflozin is a Sodium glucose cotransporter 2 inhibitor. Body weight reduction is the first line recommendation in NAFLD patients. Dapagliflizin has a strong potential to reduce body weight. We plan to study the efficacy of Saroglitazar in comparison to Dapagliflozin in NAFLD patients having type 2 DM.

Materials and methods : A prospective randomised study on therapeutic effects of saraglitazar and dapagliflozin in patients having NAFLD with type 2 Diabetes presenting to Saveetha Medical College Hospital between June 1, 2023 and June 1, 2024. NAFLD patients having Type 2 diabetes mellitus will be divided into 2 groups:

A) Will be administered Saroglitazar 4mg/day for 14 weeks B) Will be administered Dapogliflozin 10 mg/day for 14 weeks

The participants will be subjected to the following tests

Blood tests: AST, ALT, serum lipid profile, HbA1C, FBS,PPBS, platelet count, albumin Liver shear wave elastography Anthropometry â€“ Body weight, BMI, Waist circumference

A comparison of therapeutic effects of saroglitazar and dapagliflozin will be made by assessing above mentioned parameters at baseline and after 14 weeks

To our knowledge, this study works to adds a new indication for dapagliflozinnin the treatment of NAFLD. Our current work aims to compare the associations of the (Nonalcoholic fatty liver disease) NAFLD with Type 2 Diabetes Mellitus and dyslipidemia (DL). The factors associated with Type 2 DM, DL, NAFLD are to be analyzed. Also, the safety of both drugs (Dapagliflozinnand Saroglitazar) are compared on NAFLD in diabetes dyslipidemic patients. The efficacies of both the drugs in lowering the lipid profile and glucose levels will be monitored.

This study investigates biomarkers for glycemic control (hemoglobin A1c and random blood glucose, insulin), lipid metabolism (triglycerides, total cholesterol, high-density lipoprotein [HDL], and low-density lipoprotein [LDL]), albumin, and hepatic cholestasis (gamma-glutamyl transferase [GGT]) in NAFLD. Its mean purpose was to determine whether these biomarkers could detect improvement in progression of NAFLD in Diabetic dyslipidemic patients receiving Dapagliflozin and Saroglitazar.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients with NAFLD diagnosed on ultrasonography 2.HbA1C>6.5% 3.BMI>25 4.Willingness to comply with all protocol required evaluations.

Exclusion Criteria

1.Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
Average alcohol consumption greater than equal to 21 drinks per week formen, greater than equal to 14 drinks per week for women in the 6 months before enrollment.
3.The patients who already used medications known to cause hepatic steatosis for more than two weeks in the past year such as mipomersen, lomitapide, amiodarone, methotrexate, tamoxifen, corticosteroid, valproate, antiretroviral medicines.
4.Presence of alternative cause of fatty liver, including Total Parenteral Nutrition, Starvation, Lipodystrophy, -Abetalipoproteinemia, Acute fatty liver of pregnancy, HELLP syndrome, Reyeâ€™s syndrome.
Clinical, imaging, or histological evidence of cirrhosis.
5.Use of drugs with a potential effect on NASH such as ursodeoxycholic acid, vitamin E, pioglitazone.
6.Pregnant or lactating female.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NAFLD fibrosis score	0,14 weeks

Secondary Outcome Measures

Name	Time	Method
Serum lipid profile	0,14 weeks
AST,ALT	0,14 weeks
Liver shear wave elastography	0,14 weeks

Trial Locations

Locations (1): Saveetha Medical college
🇮🇳
Chennai, TAMIL NADU, India
Saveetha Medical college
🇮🇳Chennai, TAMIL NADU, India
Dr Deepthi V
Principal investigator
9003952904
vakatideepthi@yahoo.com