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Non-alcoholic Fatty Liver Disease and Its Treatment

NCT ID: NCT05480007

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-30

Study Completion Date

2018-12-01

Brief Summary

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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

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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.

Conditions

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NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

did not take medicine

Group Type NO_INTERVENTION

No interventions assigned to this group

DPPVI

received sitagliptin treatment (100mg per day)

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

sitagliptin treatment (100mg per day)

metformin

received metformin (500mg three times per day)

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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

metformin +DPPVI

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

Group Type EXPERIMENTAL

sitagliptin and metformin

Intervention Type DRUG

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

Interventions

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sitagliptin and metformin

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

Intervention Type DRUG

Sitagliptin

sitagliptin treatment (100mg per day)

Intervention Type DRUG

Metformin

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

Intervention Type DRUG

Other Intervention Names

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DPP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhang Manna

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 36072931 (View on PubMed)

Other Identifiers

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085348

Identifier Type: -

Identifier Source: org_study_id