Non-alcoholic Fatty Liver Disease and Its Treatment

Not Applicable

Completed

• Conditions: NAFLD
• Interventions: Drug: Sitagliptin; Drug: Metformin; Drug: sitagliptin and metformin

• Registration Number: NCT05480007
• Lead Sponsor: Shanghai 10th People's Hospital

Brief 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.

Study Timeline

• Study Start: 2011-01-30
• Primary Completion: 2015-12-01
• Study Completion: 2018-12-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-24
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• age 30-70 years old
• fulfillment of the diagnostic criteria for T2DM by WHO in 1999 (HbA1c ranged from 7% to 10%, FPG < 11 mol/l, 2-hour blood glucose postprandial < 20mmol/l)
• Fulfillment of the diagnostic criteria for NAFLD according to the guidelines of the Chinese Medical Association in 2010. The IHL content was measured by using 1H-magnetic resonance spectroscopy (1H-MRS) quantitative detection, and the liver fat content of the enrolled subjects was more than 5.5%. The subjects included in this study had either no history of alcohol consumption or their alcohol intake was less than 70 g/week in males and less than 140 g/week in females. Liver transaminase and serum creatinine were less than two times the upper limit of normal

Exclusion Criteria

• T2DM complicated with ketoacidosis, hyperosmolarity, acute and chronic infection ● serious heart, liver, kidney, lung disease, and liver damage
• alcoholic fatty liver
• drug use that influences glucose metabolism such as thiazide diuretics and hormones within three months
• Hypertension ≥ 180/110 mmHg
• gastrointestinal disease or absorption dysfunction
• recent trauma, surgery, or other conditions resulting in an increased stress response within the past three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DPPVI	Sitagliptin	received sitagliptin treatment (100mg per day)
metformin	Metformin	received metformin (500mg three times per day)
metformin +DPPVI	sitagliptin and metformin	received sitagliptin (100mg per day) and metformin (500 mg three times per day)

Primary Outcome Measures

Name	Time	Method
intrahepatic lipid (IHL)	24weeks	hepatic steatosis