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NCT01674972 Clinical Trial

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

Non Alcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01674972
Other study ID # EKBB 224/02.2
Secondary ID
Status Completed
Phase N/A
First received August 24, 2012
Last updated August 24, 2012
Start date January 2011
Est. completion date June 2012

Study information
Verified date August 2012
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date June 2012
Est. primary completion date April 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Oral glucose tolerance test
Oral intake of 75 g glucose after overnight fast

Locations
Country Name City State
Switzerland University Hospital Basel, Division of Gastroenterology and Hepatology Basel

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glucagon-like Peptide 1 (GLP-1) secretion in response to oGTT 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 No
Secondary Insulin secretion and glucose curves in response to oGTT 0, 15, 30, 60, 90, 120 min. after glucose administration No
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