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

August 24, 2012 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel, Division of Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy proven NAFLD and NASH will be recruited from the Hepatology Outpatient Clinic, Division of Gastroenterology and Hepatology, University Hospital Basel.

Healthy control subjects will be matched to NAFLD and NASH patients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NAFLD
Patients with biopsy proven NAFLD
Other: Oral glucose tolerance test
Oral intake of 75 g glucose after overnight fast
Control
Matched healthy control subjects
Other: Oral glucose tolerance test
Oral intake of 75 g glucose after overnight fast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT
Time Frame: 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.
0, 15, 30, 60, 90, 120 min. after glucose administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin secretion and glucose curves in response to oGTT
Time Frame: 0, 15, 30, 60, 90, 120 min. after glucose administration
0, 15, 30, 60, 90, 120 min. after glucose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Christoph Beglinger, MD, University Hospital Basel, Division of Gastroenterology and Hepatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 24, 2012

First Posted (ESTIMATE)

August 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2012

Last Update Submitted That Met QC Criteria

August 24, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKBB 224/02.2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Alcoholic Fatty Liver Disease

Clinical Trials on Oral glucose tolerance test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe