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Completed

NCT Number: NCT05480007

Non-alcoholic Fatty Liver Disease and Its Treatment

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sitagliptin and metformin

Drug

sitagliptin plus metformin group who received sitagliptin (100mg per day) and metformin (500 mg three times per day) (20 patients)

Other names: DPP

Sitagliptin

Drug

sitagliptin treatment (100mg per day)

metformin

Drug

metformin group who received metformin (500mg three times per day)

Primary outcomes

  1. intrahepatic lipid (IHL)

    Time frame: 24weeks

    hepatic steatosis

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Jul 29, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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