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Non-alcoholic Fatty Liver Disease and Its Treatment

Sponsor
Shanghai 10th People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05480007
Collaborator
(none)
68
Enrollment
4
Arms
94
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of DPP-4I and Related Treatment on Non-alcoholic Fatty Liver Disease
Actual Study Start Date :
Jan 30, 2011
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

did not take medicine
Experimental: DPPVI

received sitagliptin treatment (100mg per day)

Drug: Sitagliptin
sitagliptin treatment (100mg per day)
Experimental: metformin

received metformin (500mg three times per day)

Drug: Metformin
metformin group who received metformin (500mg three times per day)
Experimental: metformin +DPPVI

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

Drug: sitagliptin and metformin
sitagliptin plus metformin group who received sitagliptin (100mg per day) and metformin (500 mg three times per day) (20 patients)
Other Names:
  • DPP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. intrahepatic lipid (IHL) [24weeks]

      hepatic steatosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    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:

    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shanghai 10th People's Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhang Manna, Professor, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05480007
    Other Study ID Numbers:
    • 085348
    First Posted:
    Jul 29, 2022
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Metformin
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Jul 29, 2022