ClinicalTrials.gg
CompletedNCT03305783Updated Feb 9, 2023

The Influence of Cholecystectomy on Secretion of Incretin Hormones

An observational study in Glucose Metabolism Disorders, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by University Hospital, Gentofte, Copenhagen · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 39 studies in Glucose Metabolism Disorders with a site in Denmark — 3 open to participants now, 4 under way, 1 of them phase 3. Glucose Metabolism Disorders · Denmark.

Started
2017
with 5 others
Observational
5 of 39
1 open now
Registered
18th of 39
by date
Lead sponsor
9 of 39
University Hospital, Gentofte, Copenhagen

Among the 39 studies in Glucose Metabolism Disorders with a site in Denmark, this one is one of 6 that started in 2017, is one of 5 observational ones, and was the 18th registered.

Glucose Metabolism Disorders

361 studies on the registry are indexed under Glucose Metabolism Disorders; 38 are open to participants now.

Browse Glucose Metabolism Disorders studies →

Open to participants now

3 of the 39 studies in Glucose Metabolism Disorders with a site in Denmark are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 29 Glucose Metabolism Disorders studies recruiting now, 9 (31%) set no upper age limit and 18 (62%) stop at 75 or younger; 7 take children under 18; 11 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 39 studies in Glucose Metabolism Disorders with a site in Denmark, or all of them as a file.
02

Study 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 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).

03

Conditions studied

  • Glucose Metabolism Disorders
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

A healthy, normal weight population undergoing elective surgery because of gall stone disease.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • caucasians above 18 years of age, having an elective cholecystectomy performed because of gallstone disease.
  • normal fasting plasma glucose and
  • normal hgb
  • Normal gallbladder ejection fraction

Exclusion criteria

Exclusion Criteria:

  • liver disease
  • kidney disease
  • diabetes
  • ongoing infection
  • abdominal pain not related to gall stones
  • \<18,5 kg/m2 eller BMI >30 kg/m2
  • prior abdominal surgery
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients having cholecystectomy

    Healthy, normal weight patients (BMI\<27) undergoing elective cholecystectomy will have a meal test performed before and after surgery.

    Procedure: cholecystectomy

  • Healthy controls

    Healthy matched controls will have one meal test performed.

Interventions

  • Procedurecholecystectomy

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

06

What researchers measure

Primary outcomes

  1. Postprandial GLP-1 response

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

    Time frame: 240 min

Secondary outcomes

  1. plasma glucose

    measured in mmol/liter

    Time frame: 240 min

  2. gastric emptying

    evaluated by the paracetamol method

    Time frame: 240 min

  3. Resting metabolic rate

    evaluated by calorimetry

    Time frame: 240 min

  4. insulin

    measured in pmol/liter

    Time frame: 240 min

  5. Glucagon

    measured in pmol/liter

    Time frame: 240 min

  6. PYY

    peptide YY, measured in pmol/liter

    Time frame: 240 min

  7. GIP

    measured in pmol/liter

    Time frame: 240 min

  8. CCK

    Cholecystokinin, measured in pmol/liter

    Time frame: 240 min

  9. FGF-19

    Fibroblast growth factor 19, measured in ng/mL

    Time frame: 240 min

  10. Gastrin

    measured in pmol/liter

    Time frame: 240 min

  11. Bile acids

    measured in nmol/ml

    Time frame: 240 min

07

Study locations

1 site
  • Center for Clinical Metabolic Research
    Copenhagen, Hellerup 2900, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Mar 2022, 52 months.

Of 23 observational studies under Glucose Metabolism Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 67. This study's 52 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2017
First posted
Oct 10, 2017
StartActual
Nov 1, 2017
Primary completionActual
Mar 11, 2022
CompletionActual
Apr 1, 2022
Last update
Feb 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03305783
Responsible party
Henriette Holst Nerild (MD, Ph.D. student, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Oct 10, 2017
Start date
Nov 1, 2017
Primary completion
Mar 11, 2022
Completion
Apr 1, 2022
Last update
Feb 9, 2023

Study contacts

Filip K Knop, MD. Proff.
study director · Center for Clinical Metabolic Research, Gentofte hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion