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| ID | Type | Description | Link |
|---|---|---|---|
| H-1-2011-082 | Other Identifier | The Danish National Committee on Biomedical Research Ethics |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFLD | Non alcoholic fatty liver disease without type 2 diabetes |
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| NAFLD+T2D | Non alcoholic fatty liver disease with type 2 diabetes |
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| T2D | Type 2 diabetics without non alcoholic fatty liver disease |
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| cirrhosis | Patients with liver cirrhosis |
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| Kontrol groups | Healthy control subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OGTT | Other | 50g waterfree glucose dissolved in 300 ml water consumed over 5 min. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Plasma Glucose-dependent insulinotropic peptide (GIP) response |
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I) Group 1: NAFLD patients with normal glucose tolerance Inclusion criteria
II) Group 2: NAFLD patients with type 2 diabetes Inclusion criteria
III) Group 3: NAFLD patients without type 2 diabetes Inclusion criteria
IV) Group 4: Cirrhosis with or without type 2 diabetes Inclusion criteria
V) Group 5: Healthy controls Inclusion criteria
Exclusion criteria (all groups)
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Patients with NAFLD and liver cirrhosis confirmed by liver biopsy, and patients with or without well characterized type 2 diabetes recruited in the the hospitals out patients clinic
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| Name | Affiliation | Role |
|---|---|---|
| Anders E Junker, MD, phd-student | Diabetes Research Division, Gentofte Hospital, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Research Division, Gentofte University Hospital, Niels Andersens Vej 65, opgang 4b, 1. sal | Hellerup | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38035766 | Derived | Lauritsen JV, Bergmann N, Junker AE, Gyldenlove M, Skov L, Gluud LL, Hartmann B, Holst JJ, Vilsboll T, Knop FK. Oral glucose has little or no effect on appetite and satiety sensations despite a significant gastrointestinal response. Eur J Endocrinol. 2023 Dec 6;189(6):619-626. doi: 10.1093/ejendo/lvad161. | |
| 29506157 | Derived |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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DNA (whole blood) will be kept for 15 years
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| IIGI | Other | iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose |
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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 |
| 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 |
| Maagensen H, Junker AE, Jorgensen NR, Gluud LL, Knop FK, Vilsboll T. Bone Turnover Markers in Patients With Nonalcoholic Fatty Liver Disease and/or Type 2 Diabetes During Oral Glucose and Isoglycemic Intravenous Glucose. J Clin Endocrinol Metab. 2018 May 1;103(5):2042-2049. doi: 10.1210/jc.2018-00176. |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |