Actively Recruiting
Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD
Led by Zhujiang Hospital · Updated on 2024-06-10
100
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes within the last 5 years according to WHO 2019 criteria
- Aware of the study purpose, willing to participate, and able to comply with all study requirements including follow-up
- Blood glucose well-controlled by diet and exercise or stable treatment with 1 or 2 types of hypoglycemic drugs for at least 8 weeks
- HbA1c level between 7.0% and 8.5%
- Diagnosed with nonalcoholic fatty liver disease according to 2010 guidelines
You will not qualify if you...
- Type 1 diabetes, gestational diabetes, or other special diabetes types
- Acute or chronic complications or risks that outweigh benefits, including serious diabetic complications in past 6 months
- Serious liver dysfunction, chronic kidney disease, or other significant system diseases
- Recent history of myocardial infarction, unstable angina, stroke, or heart failure
- Uncontrolled hypertension with systolic ≥160 mmHg or diastolic ≥100 mmHg
- Other endocrine diseases affecting glucose/lipid metabolism or body weight
- History of malignant tumors within 5 years except treated basal cell carcinoma
- Severe infection, trauma, or major surgery within 3 months
- History of drug abuse within 5 years
- Participation in other drug or device trials within 3 months
- Severe anemia or need for regular blood transfusion
- Recent use of drugs affecting weight or blood glucose
- Planned or past bariatric surgery
- Abnormal liver enzymes or low kidney function
- Pregnancy or breastfeeding
- History of infectious diseases such as hepatitis B/C, tuberculosis, HIV, or syphilis
- Use of anti-NASH drugs within 3 months
- Genitourinary abnormalities prone to infection
- Blood disorders causing hemolysis or unstable red blood cells
- Use of immunomodulators or biological agents
- Presence of MRI-incompatible metal or devices
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Hong Chen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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