Can the Combination of Dapagliflozin and Pioglitazone in Non Alcoholic Fatty Liver Disease with Type2 Diabetes Mellitus patients will have similar effect as Dapagliflozin or Pioglitazone alone?

Phase 4

Not yet recruiting

• Conditions: Hepatic fibrosis with hepatic sclerosis,

• Registration Number: CTRI/2025/03/082781
• Lead Sponsor: BOLISETTY TULASI DEVI

Brief Summary

aim- TO COMPARE THE EFFECT OF DAPAGLIFLOZIN, PIOGLITAZONE AND A COMBINATION OF DAPAGLIFLOZIN AND PIOGLITAZONE ON STEATOSIS AND FIBROSIS IN NON ALCOHOLIC FATTY LIVER DISEASE PATIENTS WITH TYPE 2 DIABETES MELLITUS

objective- to evaluate and compare the effect of dapagliflozin, pioglitazone, and combination of both these drugs in patients of non alcoholic fatty liver disease with type 2 diabetes



drug- Dapagliflozin 10mg which is a SGLT2 inhibitor, Pioglitazone 15mg which is Thiazolinedione



patients of NAFLD with type 2 diabetes are taken and they are randomised into 3 groups. one group will receive dapagliflozin 10mg once daily, the 2nd group will receive pioglitazone 15mg once daily, 3rd group will receive a combination of both dapagliflozin 10mg and pioglitazone 15mg once daily for 3 months. The effect of drugs in the 3 groups will be evaluated and compared after 3 months using different liver parameters

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-18
• Study Start: 2025-03-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

presence of fatty liver on ultrasound with deranged liver enzymes who are known cases of non alcoholic fatty liver disease spectrum with type 2DM and HbA1c of more than 6.5.

Exclusion Criteria

• patients of chronic or viral hepatitis B or C infection, significant alcohol intake of more than 30g in males and 20g per day in females after converting to ethanol, cases with history of hepatotoxic drugs, drugs leading to hepatic fibrosis or drugs supposed to decrease hepatic fibrosis like omega 3 fatty acids, vitamin E, UDCA, saroglitazar, pioglitazone, GLP1 agonists, documented cases of autoimmune hepatitis, hepatic storage or hereditary diseases, Wilsons, hemochromatosis will be excluded.
• patients with severe renal dysfunction, ischemic heart disease, heart failure with NYHA grade 3 at present or past, complicated UTI or pyelonephritis, Pregnant and lactating females will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Liver stiffness measurement score by Transient elastography, SGOT, SGPT, TPC, APRI, FIB 4, NAFLD FIBROSIS SCORE	once before initiating the drug and once after completion of 3 months course

Secondary Outcome Measures

Name	Time	Method
HbA1c	3 months

Trial Locations

Locations (1)

IMS and SUM HOSPITAL; 🇮🇳 Khordha, ORISSA, India

IMS and SUM HOSPITAL

🇮🇳Khordha, ORISSA, India

Dr Bolisetty Tulasi Devi

Principal investigator

9618676365

lassy.bolisetty@gmail.com