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).
Study Type
OBSERVATIONAL
Enrollment
40
elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
Center for Clinical Metabolic Research
Copenhagen, Hellerup, Denmark
Postprandial GLP-1 response
Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
Time frame: 240 min
plasma glucose
measured in mmol/liter
Time frame: 240 min
gastric emptying
evaluated by the paracetamol method
Time frame: 240 min
Resting metabolic rate
evaluated by calorimetry
Time frame: 240 min
insulin
measured in pmol/liter
Time frame: 240 min
Glucagon
measured in pmol/liter
Time frame: 240 min
PYY
peptide YY, measured in pmol/liter
Time frame: 240 min
GIP
measured in pmol/liter
Time frame: 240 min
CCK
Cholecystokinin, measured in pmol/liter
Time frame: 240 min
FGF-19
Fibroblast growth factor 19, measured in ng/mL
Time frame: 240 min
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Gastrin
measured in pmol/liter
Time frame: 240 min
Bile acids
measured in nmol/ml
Time frame: 240 min