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Clinical Trial Details

Trial ID: L7153
Source ID: NCT06449833
Associated Drug: Henagliflozein And Metformin
Title: Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD
Acronym: HHTN
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus|Nonalcoholic Fatty Liver Disease
Interventions: DRUG: Henagliflozein and Metformin|DRUG: Linagliptin and Metformin
Outcome Measures: Primary: The difference of liver fat content (magnetic resonance imaging proton density fat fraction,MRI-PDFF)) between the subjects and the control group., 24 weeks | Secondary: The changes of liver enzymes (ALT)., 24 weeks|The changes of liver enzymes (AST)., 24 weeks|The changes of liver enzymes(GGT)., 24 weeks|The changes of hepatic fibrosis indexes(glutathione reductase)., 24 weeks|The changes of hepatic fibrosis indexes(total bile acid)., 24 weeks|The changes of hepatic fibrosis indexes(fibronectin)., 24 weeks|The changes of hepatic fibrosis indexes(N-terminal brain of type I procollagen.)., 24 weeks|The changes of hepatic fibrosis indexes(hyaluronic acid)., 24 weeks|The changes of hepatic fibrosis indexes(laminin)., 24 weeks|The changes of hepatic fibrosis indexes(type IV collagen)., 24 weeks|The changes of hepatic fibrosis indexes(glycocholic acid.)., 24 weeks|Changes of visceral fat volume., 24 weeks|Changes of subcutaneous fat volume., 24 weeks|Changes of fasting blood glucose., 24 weeks|Changes of fasting insulin., 24 weeks|Changes of HbA1c., 24 weeks|Changes of (HOMA-R)., 24 weeks|Blood lipid index(TC)., 24 weeks|Blood lipid index(TG)., 24 weeks|Blood lipid index(HDL-C)., 24 weeks|Blood lipid index(LDL-C)., 24 weeks|Changes of body weight., 24 weeks|Changes of BMI., 24 weeks|Changes of waist circumference., 24 weeks|Changes of hip circumference., 24 weeks|Changes of WHR., 24 weeks
Sponsor/Collaborators: Sponsor: Zhujiang Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-11
Results First Posted:
Last Update Posted: 2024-06-10
Locations: Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, 510000, China
URL: https://clinicaltrials.gov/show/NCT06449833