Type 2 Diabetes Clinical Trial
Official title:
Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | July 2014 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Diabetes Research Division, Gentofte University Hospital, Niels Andersens Vej 65, opgang 4b, 1. sal | Hellerup |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Incretin effect | 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 | pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose | No |
Secondary | Plasma Glucagon like peptide 1 (GLP-1) response | Comparing GLP-1 responses of the different experimental days, compared to healthy control subjects. | pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose | No |
Secondary | Plasma Glucose-dependent insulinotropic peptide (GIP) response | Comparing GIP responses of the different experimental days, compared to healthy control subjects. | pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose | No |
Secondary | Plasma glucagon response | Comparing glucagon responses of the different experimental days, compared to healthy control subjects. | pre dose 0,10, 20, 30, 40, 50, 60, 75, 90, 120, 150, 180, 240 min post dose | No |
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