Non-alcoholic Fatty Liver Disease and Its Treatment

NCT05480007 | Completed

• 1 other identifier: 085348
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• intrahepatic lipid (IHL)

  hepatic steatosis

  24weeks

Study Arms (4)

Control

NO INTERVENTION

did not take medicine

DPPVI

EXPERIMENTAL

received sitagliptin treatment (100mg per day)

Drug: Sitagliptin

metformin

EXPERIMENTAL

received metformin (500mg three times per day)

Drug: Metformin

metformin +DPPVI

EXPERIMENTAL

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

Drug: sitagliptin and metformin

Interventions

sitagliptin and metformin DRUG

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

Also known as: DPP

metformin +DPPVI

Sitagliptin DRUG

sitagliptin treatment (100mg per day)

DPPVI

Metformin DRUG

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

metformin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Related Publications (1)

• 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.

  PMID: 36072931 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Sitagliptin Phosphate; Metformin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 29, 2022
• Study Start: January 30, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: July 29, 2022

Record last verified: 2022-07