The Influence of Cholecystectomy on Secretion of Incretin Hormones

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Denmark
  • Hellerup
    • Copenhagen, Hellerup, Denmark, 2900
      • Center for Clinical Metabolic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A healthy, normal weight population undergoing elective surgery because of gall stone disease.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Investigators: Study Director: Filip K Knop, MD. Proff., Center for Clinical Metabolic Research, Gentofte Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): March 11, 2022
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (ACTUAL): October 10, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: H-15016324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No