The Influence of Cholecystectomy on Secretion of Incretin Hormones
- Conditions
- Glucose Metabolism Disorders
- Interventions
- Procedure: cholecystectomy
- Registration Number
- NCT03305783
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients having cholecystectomy cholecystectomy Healthy, normal weight patients (BMI\<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery.
- Primary Outcome Measures
Name Time Method Postprandial GLP-1 response 240 min Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
- Secondary Outcome Measures
Name Time Method plasma glucose 240 min measured in mmol/liter
gastric emptying 240 min evaluated by the paracetamol method
Resting metabolic rate 240 min evaluated by calorimetry
insulin 240 min measured in pmol/liter
PYY 240 min peptide YY, measured in pmol/liter
GIP 240 min measured in pmol/liter
CCK 240 min Cholecystokinin, measured in pmol/liter
Glucagon 240 min 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
Trial Locations
- Locations (1)
Center for Clinical Metabolic Research
🇩🇰Copenhagen, Hellerup, Denmark