Status:
COMPLETED
Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
Non Alcoholic Fatty Liver Disease
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
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 ci...
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.
Eligibility Criteria
Inclusion
- I) Group 1: NAFLD patients with normal glucose tolerance Inclusion criteria
- NAFLD verified by a liver biopsy
- Caucasian \>18 years of age
- Negative islet cell (ICA) and glutamic acid decarboxylase 65 (GAD65) autoantibodies
- Normal 75-g OGTT as specified in the WHO Criteria
- Normal haemoglobin and blood pressure (BP)
- Written informed consent
- II) Group 2: NAFLD patients with type 2 diabetes Inclusion criteria
- NAFLD verified by liver biopsy
- T2DM according to the WHO Criteria
- Caucasian \>18 years of age
- Negative ICA and GAD65, normal haemoglobin, normal BP
- Written informed consent
- III) Group 3: NAFLD patients without type 2 diabetes Inclusion criteria
- NAFLD verified by liver biopsy
- Caucasian \>18 years of age
- Normal 75-g OGTT
- Negative ICA and GAD65-autoantibodies
- Normal haemoglobin and BP
- Written informed consent
- IV) Group 4: Cirrhosis with or without type 2 diabetes Inclusion criteria
- Liver cirrhosis verified by liver biopsy
- Caucasian \> 18 years of age
- Negative ICA and GAD65-autoantibodies
- Normal haemoglobin and BP
- Written informed consent
- V) Group 5: Healthy controls Inclusion criteria
- Caucasian \>18 years of age
- Normal 75-g OGTT according to the WHO Criteria
- Negative ICA and GAD65-autoantibodies
- Normal haemoglobin and BP
- Written informed consent
- Exclusion criteria (all groups)
- Other known liver disease - viral hepatitis, hereditary haemochromatosis, autoimmune liver disease, alpha-1 trypsin deficiency, Wilson disease, drug induced liver Injury (DILI)
- Treatment with medications that cannot be discontinued for 12 hours
- Unwillingness to participate in protocols
- Pregnancy or lactation
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01492283
Start Date
December 1 2011
End Date
July 1 2014
Last Update
July 10 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Diabetes Research Division, Gentofte University Hospital, Niels Andersens Vej 65, opgang 4b, 1. sal
Hellerup, Denmark, 2900