ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01674972
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Non Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Other: Oral glucose tolerance test

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

Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Glucose-induced Glucagon-like Peptide 1 (GLP-1) Secretion in NAFLD Patients Compared to Healthy Controls
Study Start Date : January 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2012


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




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

Biospecimen Retention:   Samples With DNA
Plasma samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674972


Locations
Switzerland
University Hospital Basel, Division of Gastroenterology and Hepatology
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger, MD University Hospital Basel, Division of Gastroenterology and Hepatology

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01674972     History of Changes
Other Study ID Numbers: EKBB 224/02.2
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012

Keywords provided by University Hospital, Basel, Switzerland:
NAFLD
NASH
GLP-1

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins