Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls

Completed

• Conditions: Non Alcoholic Fatty Liver Disease; Non Alcoholic Steatohepatitis
• Interventions: Other: Oral glucose tolerance test

• Registration Number: NCT01674972
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The incretin effect is impaired in patients with type 2 diabetes mellitus (T2DM), thus GLP-1 receptor agonists are used for the treatment of T2DM. Insulin resistance is a pathophysiologic hallmark of non-alcoholic fatty liver disease (NAFLD). The incretin effect in patients with NAFLD has not been studied. The aim of this study is to quantify GLP-1 secretion in response to oral glucose tolerance test (oGTT) in patients with NAFLD compared to healthy controls. The results of this study will expand the knowledge of the pathophysiology of NAFLD and serve as a rational for potential future treatment strategies.

Detailed Description

Primary endpoint: GLP-1 response to oral glucose Secondary endpoints: glucose and insulin responses to oral glucose challenge

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-04
• Study Completion: 2012-06
• Status Verified: 2012-08
• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-08-24
• Last Update Submitted: 2012-08-24
• Study First Posted: 2012-08-29
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Biopsy proven NAFLD or NASH

Exclusion Criteria

• additional concomitants liver disease
• T2DM
• alcohol consumption >40g/d for male subjects and >20g/d for female subjects

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Oral glucose tolerance test	Matched healthy control subjects
NAFLD	Oral glucose tolerance test	Patients with biopsy proven NAFLD

Primary Outcome Measures

Name	Time	Method
Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT	0, 15, 30, 60, 90, 120 min. after glucose administration	The difference in GLP-1 secretion in response to oGTT as assessed by area under the curve (AUC) and peak plasma concentration (cmax) in patients with NAFLD compared to healthy controls.

Secondary Outcome Measures

Name	Time	Method
Insulin secretion and glucose curves in response to oGTT	0, 15, 30, 60, 90, 120 min. after glucose administration

Trial Locations

Locations (1)

University Hospital Basel, Division of Gastroenterology and Hepatology; 🇨🇭 Basel, Switzerland