Glucose Metabolism Disorders
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREcholecystectomy
elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* caucasians above 18 years of age, having an elective cholecystectomy performed because of gallstone disease. * normal fasting plasma glucose and HbA1c * normal hgb * Normal gallbladder ejection fraction
Exclusion criteria
* liver disease * kidney disease * diabetes * ongoing infection * abdominal pain not related to gall stones * BMI \<18,5 kg/m2 eller BMI \>30 kg/m2 * prior abdominal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial GLP-1 response | 240 min | Gut derived hormone secretion after a 4 h meal test measured in pmol/liter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gastric emptying | 240 min | evaluated by the paracetamol method |
| Resting metabolic rate | 240 min | evaluated by calorimetry |
| insulin | 240 min | measured in pmol/liter |
| Glucagon | 240 min | measured in pmol/liter |
| PYY | 240 min | peptide YY, measured in pmol/liter |
| plasma glucose | 240 min | measured in mmol/liter |
| CCK | 240 min | Cholecystokinin, measured in pmol/liter |
| FGF-19 | 240 min | Fibroblast growth factor 19, measured in ng/mL |
| Gastrin | 240 min | measured in pmol/liter |
| Bile acids | 240 min | measured in nmol/ml |
| GIP | 240 min | measured in pmol/liter |
Countries
Denmark
Outcome results
None listed