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The primary objective of the present study is to evaluate the effect of HMG-CoA reductase inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals. Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite, and faecal content of bile acids and gut microbiota composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Experimental | 2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily) |
|
| Placebo | Placebo Comparator | 2 weeks treatment with placebo tablets of comparable sizes and color to the Atorvastatin tablets (1st week one tablet once daily, 2nd week two tablets once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Atorvastatin tablet |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial GLP-1 secretion | 240 min |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Bile Acid Composition | 240 min | |
| Postprandial total plasma Bile Acid | 240 min | |
| Postprandial Glucose Tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Filip K. Knop, Professor MD | Department of Clinical Medicine, University of Copenhagen, Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Gentofte, Copenhagen | Hellerup | Capital Region | 2900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41738774 | Derived | Thomasen M, Misiakou MA, Li SS, Rodriguez de Evgrafov MC, Lynggaard MB, Karhus ML, Bronden A, Kornholt J, Chavez-Talavera O, Tailleux A, Staels B, Descat A, Hartmann B, Wewer Albrechtsen NJ, Rehfeld JF, Holst JJ, Vilsboll T, Ellegaard AM, Sommer MOA, Sonne DP, Knop FK. Metabolic, enterohepatic and gut microbial effects of atorvastatin in healthy men. Endocr Connect. 2026 Feb 25;15(3):e250721. doi: 10.1530/EC-25-0721. Online ahead of print. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Other |
Placebo tablet |
|
| 240 min |
| Postprandial plasma lipid response | 240 min |
| Postprandial GIP secretion | 240 min |
| Enteric hormones known to influence glucose metabolism | 240 min |
| Gallbladder emptying | 240 min |
| Faecal content of bile acid | One sample collected on day 12 or 13 of the intervention |
| Gut microbiota composition | One sample collected on day 12 or 13 of the intervention |
| Gastric emptying | 240 min |
| Resting Energy Expenditure | At time -20 min, +60 min and +220 min |
| D004700 | Endocrine System Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |