The Influence of Cholecystectomy on Secretion of Incretin Hormones

Completed

• Conditions: Glucose Metabolism Disorders

• 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).

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-10
• Study Start: 2017-11-01
• Primary Completion: 2022-03-11
• Study Completion: 2022-04-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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