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
|Condition or disease||Intervention/treatment|
|Glucose Metabolism Disorders||Procedure: cholecystectomy|
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|
|Estimated Enrollment :||30 participants|
|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|
Patients having cholecystectomy
Healthy, normal weight patients (BMI<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery.
elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
Healthy matched controls will have one meal test performed.
- Postprandial GLP-1 response [ Time Frame: 240 min ]Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
- plasma glucose [ Time Frame: 240 min ]measured in mmol/liter
- gastric emptying [ Time Frame: 240 min ]evaluated by the paracetamol method
- Resting metabolic rate [ Time Frame: 240 min ]evaluated by calorimetry
- insulin [ Time Frame: 240 min ]measured in pmol/liter
- Glucagon [ Time Frame: 240 min ]measured in pmol/liter
- PYY [ Time Frame: 240 min ]peptide YY, measured in pmol/liter
- GIP [ Time Frame: 240 min ]measured in pmol/liter
- CCK [ Time Frame: 240 min ]Cholecystokinin, measured in pmol/liter
- FGF-19 [ Time Frame: 240 min ]Fibroblast growth factor 19, measured in ng/mL
- Gastrin [ Time Frame: 240 min ]measured in pmol/liter
- Bile acids [ Time Frame: 240 min ]measured in nmol/ml
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03305783
|Contact: Christina C. Nexoe-Larsen, MDemail@example.com|
|Contact: Filip K. knop, MD. Proff.||firstname.lastname@example.org|
|Clinical metabolic physiology, Steno Diabetes Center Copenhagen||Recruiting|
|Copenhagen, Hellerup, Denmark, 2900|
|Contact: Christina C Nexøe-Larsen, MD, Ph.D. student|
|Study Director:||Filip K Knop, MD. Proff.||Center for Diabetes research, Gentofte hospital|