The Influence of Cholecystectomy on Secretion of Incretin Hormones

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-04-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Glucose Metabolism Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients having cholecystectomy

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

cholecystectomy

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

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cholecystectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes