The Influence of Cholecystectomy on Secretion of Incretin Hormones

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Glucose Metabolism Disorders

Treatments: Procedure: cholecystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03305783

H-15016324

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Patients having cholecystectomy

Description:

Healthy, normal weight patients (BMI\<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery.

Treatment:

Procedure: cholecystectomy

Healthy controls

Description:

Healthy matched controls will have one meal test performed.