The Influence of Cholecystectomy on Secretion of Incretin Hormones

Glucose Metabolism Disorders Clinical Trial

Official title:

The Influence of Cholecystectomy on Secretion of Incretin Hormones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03305783
• Other study ID #: H-15016324
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Procedure:
• cholecystectomy
elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research	Copenhagen	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial GLP-1 response	Gut derived hormone secretion after a 4 h meal test measured in pmol/liter	240 min
Secondary	plasma glucose	measured in mmol/liter	240 min
Secondary	gastric emptying	evaluated by the paracetamol method	240 min
Secondary	Resting metabolic rate	evaluated by calorimetry	240 min
Secondary	insulin	measured in pmol/liter	240 min
Secondary	Glucagon	measured in pmol/liter	240 min
Secondary	PYY	peptide YY, measured in pmol/liter	240 min
Secondary	GIP	measured in pmol/liter	240 min
Secondary	CCK	Cholecystokinin, measured in pmol/liter	240 min
Secondary	FGF-19	Fibroblast growth factor 19, measured in ng/mL	240 min
Secondary	Gastrin	measured in pmol/liter	240 min
Secondary	Bile acids	measured in nmol/ml	240 min