The Influence of Cholecystectomy on Secretion of Incretin Hormones

Study Overview
=================
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).

Official Title
-----------------
The Influence of Cholecystectomy on Secretion of Incretin Hormones

Conditions
-----------------
Glucose Metabolism Disorders

Intervention / Treatment
-----------------
* Procedure: cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients having cholecystectomy<br>Healthy, normal weight patients (BMI<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery. | Procedure: cholecystectomy<br>* elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.<br>|
| Healthy controls<br>Healthy matched controls will have one meal test performed. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial GLP-1 response | Gut derived hormone secretion after a 4 h meal test measured in pmol/liter | 240 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose | measured in mmol/liter | 240 min | 
| gastric emptying | evaluated by the paracetamol method | 240 min | 
| 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 |