NCT05480007

Non-alcoholic Fatty Liver Disease and Its Treatment

Effect of DPP-4I and Related Treatment on Non-alcoholic Fatty Liver Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Dipeptidyl peptidase-4 inhibitors (DPP-4I), key regulators of the actions of incretin hormones, exert anti-hyperglycemic effects in type 2 diabetes mellitus (T2DM) patients. A major unanswered question concerns the potential ability of DPP-4I to improve intrahepatic lipid (IHL) content in nonalcoholic fatty liver disease (NAFLD) patients. The aim of this study was to evaluate the effects of sitagliptin on IHL in NAFLD patients.

Detailed description

A prospective, 24-week, single-center, open-label, comparative study enrolled 68 Chinese NAFLD patients with T2DM. Subjects were randomly divided into 4 groups: control group who did not take medicine (14 patients); sitagliptin group who received sitagliptin treatment (100mg per day) (17 patients); metformin group who received metformin (500mg three times per day) (17 patients); and sitagliptin plus metformin group who received sitagliptin (100mg per day) and metformin (500 mg three times per day) (20 patients). IHL, physical examination (waist circumstances, WC; body mass index, BMI), glucose-lipid metabolism (fasting plasma glucose, FPG; hemoglobin A1c, Hb1A1c; triglycerides; cholesterol; alanine aminotransferase, ALT; aspartate aminotransferase, AST) were measured at baseline and at 24 weeks.

Conditions

• NAFLD

Interventions

Type	Name	Description
DRUG	sitagliptin and metformin	sitagliptin plus metformin group who received sitagliptin (100mg per day) and metformin (500 mg three times per day) (20 patients)
DRUG	Sitagliptin	sitagliptin treatment (100mg per day)
DRUG	Metformin	metformin group who received metformin (500mg three times per day)

Timeline

• Start date: 2011-01-30
• Primary completion: 2015-12-01
• Completion: 2018-12-01
• First posted: 2022-07-29
• Last updated: 2022-07-29