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

NCT ID: NCT01674972

Last Updated: 2012-08-29

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

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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

Conditions

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Non Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis

Keywords

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NAFLD NASH GLP-1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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NAFLD

Patients with biopsy proven NAFLD

Oral glucose tolerance test

Intervention Type OTHER

Oral intake of 75 g glucose after overnight fast

Control

Matched healthy control subjects

Oral glucose tolerance test

Intervention Type OTHER

Oral intake of 75 g glucose after overnight fast

Interventions

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Oral glucose tolerance test

Oral intake of 75 g glucose after overnight fast

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Beglinger, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Division of Gastroenterology and Hepatology

Locations

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University Hospital Basel, Division of Gastroenterology and Hepatology

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKBB 224/02.2

Identifier Type: -

Identifier Source: org_study_id