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CompletedNCT05480007Updated Jul 29, 2022

Non-alcoholic Fatty Liver Disease and Its Treatment

An interventional study of sitagliptin and metformin and Sitagliptin in NAFLD, sponsored by Shanghai 10th People's Hospital. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-29.

Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 years 5 months after the study started (first participant enrolled Jan 2011, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 68 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • No intervention
    Control

    did not take medicine

  • Experimental
    DPPVI

    received sitagliptin treatment (100mg per day)

    Drug: Sitagliptin

  • Experimental
    metformin

    received metformin (500mg three times per day)

    Drug: Metformin

  • Experimental
    metformin +DPPVI

    received sitagliptin (100mg per day) and metformin (500 mg three times per day)

    Drug: sitagliptin and metformin

Interventions

  • Drugsitagliptin and metformin

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

    Also known as: DPP

  • DrugSitagliptin

    sitagliptin treatment (100mg per day)

  • DrugMetformin

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

06

What researchers measure

Primary outcomes

  1. intrahepatic lipid (IHL)

    hepatic steatosis

    Time frame: 24weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Wang X, Zhao B, Sun H, You H, Qu S. Effects of sitagliptin on intrahepatic lipid content in patients with non-alcoholic fatty liver disease. Front Endocrinol (Lausanne). 2022 Aug 22;13:866189. doi: 10.3389/fendo.2022.866189. eCollection 2022. PubMed 36072931 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05480007
Lead sponsor
Shanghai 10th People's Hospital
Responsible party
Zhang Manna (Professor, Shanghai 10th People's Hospital) — Principal investigator
First posted
Jul 29, 2022
Start date
Jan 30, 2011
Primary completion
Dec 1, 2015
Completion
Dec 1, 2018
Last update
Jul 29, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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