RecruitingPhase 4NCT06449833

Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD

Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Multicenter, Randomized, Controlled Clinical Trial


Sponsor

Zhujiang Hospital

Enrollment

100 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether henagliflozin — a newer blood sugar-lowering drug — can reduce liver fat in people who have both type 2 diabetes and non-alcoholic fatty liver disease (NAFLD). Liver fat is measured using MRI before and after treatment. **You may be eligible if...** - You were diagnosed with type 2 diabetes within the past 5 years - Your blood sugar is reasonably well-controlled (HbA1c ≤9.5%) on stable medications (metformin or similar) for at least 8 weeks - You have been diagnosed with fatty liver disease **You may NOT be eligible if...** - Your type 2 diabetes has been diagnosed for more than 5 years - You are already on an SGLT2 inhibitor (such as empagliflozin or dapagliflozin) - You have significant kidney, liver, or heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHenagliflozein and Metformin

The experimental group will be treated with 10mg Henagliflozein and Metformin.

DRUGLinagliptin and Metformin

The control group will be treated with 5mg Linagliptin and Metformin.


Locations(1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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NCT06449833


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