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

NCT01674972 | Completed

• 1 other identifier: EKBB 224/02.2
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Fatty Liver Disease; Non Alcoholic Steatohepatitis

Keywords

NAFLD; NASH; GLP-1

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Insulin secretion and glucose curves in response to oGTT

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

Study Arms (2)

NAFLD

Patients with biopsy proven NAFLD

Other: Oral glucose tolerance test

Control

Matched healthy control subjects

Other: Oral glucose tolerance test

Interventions

Oral glucose tolerance test OTHER

Oral intake of 75 g glucose after overnight fast

Control; NAFLD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Biopsy proven NAFLD or NASH

You may not qualify if:

• additional concomitants liver disease
• T2DM
• alcohol consumption \>40g/d for male subjects and \>20g/d for female subjects

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Division of Gastroenterology and Hepatology

Basel, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Christoph Beglinger, MD

  University Hospital Basel, Division of Gastroenterology and Hepatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 29, 2012
• Study Start: January 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 29, 2012

Record last verified: 2012-08

Locations

CH (1)