Glucose Metabolism DisordersNCT03305783
The Influence of Cholecystectomy on Secretion of Incretin Hormones
An observational study of Glucose Metabolism Disorders, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2017to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A healthy, normal weight population undergoing elective surgery because of gall stone disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research
Copenhagen, Hellerup, 2900
About this study
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.
Read the 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).
- Conditions
- Glucose Metabolism Disorders
- Being tested
- cholecystectomy
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystectomyProcedure or surgery
elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients having cholecystectomy | Healthy, normal weight patients (BMI<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery. Receives: Procedure: cholecystectomy | |
| Healthy controls | Healthy matched controls will have one meal test performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial GLP-1 response
Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
Measured: 240 min
Secondary outcomes (11)
plasma glucose
measured in mmol/liter
Measured: 240 min
gastric emptying
evaluated by the paracetamol method
Measured: 240 min
Resting metabolic rate
evaluated by calorimetry
Measured: 240 min
insulin
measured in pmol/liter
Measured: 240 min
Glucagon
measured in pmol/liter
Measured: 240 min
PYY
peptide YY, measured in pmol/liter
Measured: 240 min
GIP
measured in pmol/liter
Measured: 240 min
CCK
Cholecystokinin, measured in pmol/liter
Measured: 240 min
FGF-19
Fibroblast growth factor 19, measured in ng/mL
Measured: 240 min
Gastrin
measured in pmol/liter
Measured: 240 min
Bile acids
measured in nmol/ml
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start1 Nov 2017
- Primary completion11 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henriette Holst Nerild, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD. Proff., Study director, Center for Clinical Metabolic Research, Gentofte hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305783
- Sponsor's protocol ID
- H-15016324
- Status last verified
- Feb 2023
- First submitted
- 4 Oct 2017
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cholecystectomy on Secretion of Incretin Hormones
- ClinicalTrials.gov ID
- NCT03305783
- Acronym / sponsor ID
- H-15016324
- Conditions
- Glucose Metabolism Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 10 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients having cholecystectomy | – | Procedure: cholecystectomyHealthy, 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A healthy, normal weight population undergoing elective surgery because of gall stone disease.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- liver disease
- kidney disease
- diabetes
- ongoing infection
- abdominal pain not related to gall stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecystectomyelective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study. | Procedure or surgery | Patients having cholecystectomy |
Primary outcome
Postprandial GLP-1 response
Time frame: 240 min
Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
11 secondary outcomes
plasma glucose
Time frame: 240 min
gastric emptying
Time frame: 240 min
Resting metabolic rate
Time frame: 240 min
insulin
Time frame: 240 min
Glucagon
Time frame: 240 min
PYY
Time frame: 240 min
GIP
Time frame: 240 min
CCK
Time frame: 240 min
FGF-19
Time frame: 240 min
Gastrin
Time frame: 240 min
Bile acids
Time frame: 240 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filip K Knop, MD. Proff. study director
Center for Clinical Metabolic Research, Gentofte hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucose Metabolism Disorders, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial GLP-1 response (time frame: 240 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.