Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes

Completed

• Conditions: Type 2 Diabetes; Non Alcoholic Fatty Liver Disease; Liver Cirrhosis
• Interventions: Other: OGTT; Other: IIGI

• Registration Number: NCT01492283
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

The main objective of this study is to analyze the pathophysiological implications of glucagon and the incretin hormones in patients with liver disease (Non alcoholic fatty liver disease (NAFLD) or cirrhosis) with and without diabetes compared with healthy controls. The present study will contribute significantly to the understanding of the pathophysiology of liver disease and glucose metabolism. The final goal is that the results could pave the way for new treatment modalities for patients with liver disease.

Detailed Description

Comparison of of insulin secretion (Area Under the Curve (AUC)) during the experimental days. Furthermore a comparison of GIP, GLP1 and glucagon responses as well as plasma glucose levels.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-14
• Primary Completion: 2013-05
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cirrhosis	IIGI	Patients with liver cirrhosis
Kontrol groups	OGTT	Healthy control subjects
Kontrol groups	IIGI	Healthy control subjects
NAFLD+T2D	OGTT	Non alcoholic fatty liver disease with type 2 diabetes
NAFLD+T2D	IIGI	Non alcoholic fatty liver disease with type 2 diabetes
T2D	IIGI	Type 2 diabetics without non alcoholic fatty liver disease
cirrhosis	OGTT	Patients with liver cirrhosis
NAFLD	OGTT	Non alcoholic fatty liver disease without type 2 diabetes
NAFLD	IIGI	Non alcoholic fatty liver disease without type 2 diabetes
T2D	OGTT	Type 2 diabetics without non alcoholic fatty liver disease

Primary Outcome Measures

Name	Time	Method
The Incretin effect	pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose	The difference in insulin responses, as assessed by the area under curve (AUC) for plasma insulin and C-peptide concentrations, during the two different glucose stimuli: Oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion in NAFLD patients with and without diabetes, and cirrhotic patients compared to healthy control subjects

Secondary Outcome Measures

Name	Time	Method
Plasma Glucagon like peptide 1 (GLP-1) response	pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose	Comparing GLP-1 responses of the different experimental days, compared to healthy control subjects.
Plasma glucagon response	pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose	Comparing glucagon responses of the different experimental days, compared to healthy control subjects.
Plasma Glucose-dependent insulinotropic peptide (GIP) response	pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose	Comparing GIP responses of the different experimental days, compared to healthy control subjects.

Trial Locations

Locations (1)

Diabetes Research Division, Gentofte University Hospital, Niels Andersens Vej 65, opgang 4b, 1. sal; 🇩🇰 Hellerup, Denmark