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The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic cholecystectomy.
This is an observational, parallel-group study in 30 patients with gallstone disease and 10 healthy control subjects. In patients undergoing cholecystectomy a 4h-meal test (liquid mixed meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after the cholecystectomy. Healthy subjects will be submitted to a single 4h-meal test.
Secondary endpoints include changes in plasma glucose, insulin, glucagon, GIP, PYY, gastrin, CCK, fibroblast growth factor 19 (FGF-19) and bile acids. Furthermore, secondary endpoints include changes in gastric emptying (evaluated by the paracetamol method).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients having cholecystectomy | Healthy, normal weight patients (BMI<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery. |
| |
| Healthy controls | Healthy matched controls will have one meal test performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecystectomy | Procedure | elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial GLP-1 response | Gut derived hormone secretion after a 4 h meal test measured in pmol/liter | 240 min |
| Measure | Description | Time Frame |
|---|---|---|
| plasma glucose | measured in mmol/liter | 240 min |
| gastric emptying | evaluated by the paracetamol method | 240 min |
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Inclusion Criteria:
Exclusion Criteria:
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A healthy, normal weight population undergoing elective surgery because of gall stone disease.
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| Name | Affiliation | Role |
|---|---|---|
| Filip K Knop, MD. Proff. | Center for Clinical Metabolic Research, Gentofte hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Metabolic Research | Copenhagen | Hellerup | 2900 | Denmark |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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biopsies from the gallbladder and ductus cysticus after cholecystectomy biopsies only collected from 12 subjects.
| Resting metabolic rate | evaluated by calorimetry | 240 min |
| insulin | measured in pmol/liter | 240 min |
| Glucagon | measured in pmol/liter | 240 min |
| PYY | peptide YY, measured in pmol/liter | 240 min |
| GIP | measured in pmol/liter | 240 min |
| CCK | Cholecystokinin, measured in pmol/liter | 240 min |
| FGF-19 | Fibroblast growth factor 19, measured in ng/mL | 240 min |
| Gastrin | measured in pmol/liter | 240 min |
| Bile acids | measured in nmol/ml | 240 min |