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The Influence of Cholecystectomy on Secretion of Incretin Hormones

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ClinicalTrials.gov Identifier: NCT03305783
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Christina Charlotte Nexoe-Larsen, 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.

Condition or disease Intervention/treatment
Glucose Metabolism Disorders 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).


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Influence of Cholecystectomy on Secretion of Incretin Hormones
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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.



Primary Outcome Measures :
  1. Postprandial GLP-1 response [ Time Frame: 240 min ]
    Gut derived hormone secretion after a 4 h meal test measured in pmol/liter


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
biopsies from the gallbladder and ductus cysticus after cholecystectomy


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A healthy, normal weight population undergoing elective surgery because of gall stone disease.
Criteria

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 >27 kg/m2
  • prior abdominal surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305783


Contacts
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Contact: Christina C. Nexoe-Larsen, MD 004528708077 christina.charlotte.nexoee-larsen@regionh.dk
Contact: Filip K. knop, MD. Proff. filip.kragh.knop01@regionh.dk

Locations
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Denmark
Clinical metabolic physiology, Steno Diabetes Center Copenhagen Recruiting
Copenhagen, Hellerup, Denmark, 2900
Contact: Christina C Nexøe-Larsen, MD, Ph.D. student         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
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Study Director: Filip K Knop, MD. Proff. Center for Diabetes research, Gentofte hospital

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Responsible Party: Christina Charlotte Nexoe-Larsen, MD, Ph.D. student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03305783     History of Changes
Other Study ID Numbers: H-15016324
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Metabolic Diseases
Glucose Metabolism Disorders
Hormones
Gastric Inhibitory Polypeptide
Incretins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents