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Non-alcoholic Fatty Liver Disease and Its Treatment

Primary Purpose

NAFLD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sitagliptin and metformin
Sitagliptin
Metformin
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    DPPVI

    metformin

    metformin +DPPVI

    Arm Description

    did not take medicine

    received sitagliptin treatment (100mg per day)

    received metformin (500mg three times per day)

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

    Outcomes

    Primary Outcome Measures

    intrahepatic lipid (IHL)
    hepatic steatosis

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2022
    Last Updated
    July 28, 2022
    Sponsor
    Shanghai 10th People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05480007
    Brief Title
    Non-alcoholic Fatty Liver Disease and Its Treatment
    Official Title
    Effect of DPP-4I and Related Treatment on Non-alcoholic Fatty Liver Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 30, 2011 (Actual)
    Primary Completion Date
    December 1, 2015 (Actual)
    Study Completion Date
    December 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai 10th People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    NAFLD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    did not take medicine
    Arm Title
    DPPVI
    Arm Type
    Experimental
    Arm Description
    received sitagliptin treatment (100mg per day)
    Arm Title
    metformin
    Arm Type
    Experimental
    Arm Description
    received metformin (500mg three times per day)
    Arm Title
    metformin +DPPVI
    Arm Type
    Experimental
    Arm Description
    received sitagliptin (100mg per day) and metformin (500 mg three times per day)
    Intervention Type
    Drug
    Intervention Name(s)
    sitagliptin and metformin
    Other Intervention Name(s)
    DPP
    Intervention Description
    sitagliptin plus metformin group who received sitagliptin (100mg per day) and metformin (500 mg three times per day) (20 patients)
    Intervention Type
    Drug
    Intervention Name(s)
    Sitagliptin
    Intervention Description
    sitagliptin treatment (100mg per day)
    Intervention Type
    Drug
    Intervention Name(s)
    Metformin
    Intervention Description
    metformin group who received metformin (500mg three times per day)
    Primary Outcome Measure Information:
    Title
    intrahepatic lipid (IHL)
    Description
    hepatic steatosis
    Time Frame
    24weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36072931
    Citation
    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.
    Results Reference
    derived

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    Non-alcoholic Fatty Liver Disease and Its Treatment

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