The Influence of Cholecystectomy on Secretion of Incretin Hormones
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2017
CompletedFirst Posted
Study publicly available on registry
October 10, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedFebruary 9, 2023
February 1, 2023
4.4 years
October 4, 2017
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial GLP-1 response
Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
240 min
Secondary Outcomes (11)
plasma glucose
240 min
gastric emptying
240 min
Resting metabolic rate
240 min
insulin
240 min
Glucagon
240 min
- +6 more secondary outcomes
Study Arms (2)
Patients having cholecystectomy
Healthy, normal weight patients (BMI\<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery.
Healthy controls
Healthy matched controls will have one meal test performed.
Interventions
elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
Eligibility Criteria
A healthy, normal weight population undergoing elective surgery because of gall stone disease.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Clinical Metabolic Research
Copenhagen, Hellerup, 2900, Denmark
Biospecimen
biopsies from the gallbladder and ductus cysticus after cholecystectomy biopsies only collected from 12 subjects.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Filip K Knop, MD. Proff.
Center for Clinical Metabolic Research, Gentofte hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Ph.D. student
Study Record Dates
First Submitted
October 4, 2017
First Posted
October 10, 2017
Study Start
November 1, 2017
Primary Completion
March 11, 2022
Study Completion
April 1, 2022
Last Updated
February 9, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share