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NCT Number: NCT01674972

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

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.

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Key information

Conditions

Non Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non Alcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Division of Gastroenterology and Hepatology

Basel, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glucose tolerance test

Other

Oral intake of 75 g glucose after overnight fast

Primary outcomes

  1. 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.

Secondary outcomes

  1. Insulin secretion and glucose curves in response to oGTT

    Time frame: 0, 15, 30, 60, 90, 120 min. after glucose administration

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 29, 2012
Registry last updated
Aug 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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