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NCT Number: NCT03305783

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.

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Key information

Conditions

Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Clinical Metabolic Research

Copenhagen, Hellerup, 2900, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy

Procedure

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

Primary outcomes

  1. Postprandial GLP-1 response

    Time frame: 240 min

    Gut derived hormone secretion after a 4 h meal test measured in pmol/liter

Secondary outcomes

  1. plasma glucose

    Time frame: 240 min

    measured in mmol/liter

  2. gastric emptying

    Time frame: 240 min

    evaluated by the paracetamol method

  3. Resting metabolic rate

    Time frame: 240 min

    evaluated by calorimetry

  4. insulin

    Time frame: 240 min

    measured in pmol/liter

  5. Glucagon

    Time frame: 240 min

    measured in pmol/liter

  6. PYY

    Time frame: 240 min

    peptide YY, measured in pmol/liter

  7. GIP

    Time frame: 240 min

    measured in pmol/liter

  8. CCK

    Time frame: 240 min

    Cholecystokinin, measured in pmol/liter

  9. FGF-19

    Time frame: 240 min

    Fibroblast growth factor 19, measured in ng/mL

  10. Gastrin

    Time frame: 240 min

    measured in pmol/liter

  11. Bile acids

    Time frame: 240 min

    measured in nmol/ml

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2017
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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