Effect of Glucagon-like Peptide 2 on Gallbladder MotilityEarly Phase 1NCT03682172
Effect of Glucagon-like Peptide 2 on Gallbladder Motility After a Meal in Young, Healthy Male Subjects
A Early Phase 1 study testing GLP-2 (1pmol/kg/min) and GLP-2 (10pmol/kg/min) in people with Effect of Glucagon-like Peptide 2 on Gallbladder Motility, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The study will investigate the effect of the incretin hormone glucagon-like peptide 2 (GLP-2) on postprandial gallbladder motility in young, healthy, male subjects. The study is double-blinded, randomized and placebo controlled. 15 subjects will be included. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of Glucagon-like Peptide 2 on Gallbladder Motility
- What is being tested?
- GLP-2 (1pmol/kg/min) and GLP-2 (10pmol/kg/min)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 1 Jul 2020
- Phase
- Early Phase 1
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian ethnicity
- Male
- Age: 18-35 years
- BMI: 18,5-24,9
- Fasting plasma glucose ≤ 6 mmol/l
- Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
- Normal haemoglobin (8,3-10,5 mmol/l)
- Informed and written consent
Who cannot join
- First-degree relatives with type 1 or type 2 diabetes
- Nephropathy (se-creatinin > 130 μM and/or albuminuria)
- Liver disease (alanintransaminase (ALAT) or aspartattransaminase (ASAT) > 2 × upper normal limit)
- Active or recent malignant disease
- Treatment with medicine that cannot be paused for 1 week
- Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- Any condition considered incompatible with participation by the investigators
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
Hellerup, Capital Region, 2900
About this study
Official title: Effect of Glucagon-like Peptide 2 on Postprandial Gallbladder Motility in Healthy Subjects
The study will investigate the effect of the incretin hormone glucagon-like peptide 2 (GLP-2) on postprandial gallbladder motility in young, healthy, male subjects.
The study is double-blinded, randomized and placebo controlled. 15 subjects will be included. On three separate study days (A, B, C) the subjects will receive an four hour intravenous infusion with either saline (placebo), GLP-2 at a rate of 1 pmol/kg/min or GLP-2 at a rate of 10 pmol/kg/min 30 minutes after the infusion start the subject will receive a liquid meal which will stimulate gallbladder contraction.
The gallbladder volume will be determined by frequent ultrasonic scans, and blood samples will be drawn on fixed times through out the study day.
Read the detailed description
Study design The primary endpoint is the incremental Area Under the Curve (iAUC) of the gallbladder Ejection Fraction % (EF) at time 0-210 minutes. Gallbladder volume will be measured during a four hour intravenous GLP-2 infusion at two different concentrations (1 pmol/kg body weight/min and 10pmol/kg body weight/min), respectively, compared to placebo after ingestion of a liquid meal in healthy, young, male subjects. The gallbladder volume will be quantified by multiple ultrasonography scans at fixed times during the experimental study days.
Gallbladder ejection fraction (EF%) will be calculated as following:
Gallbladder EF = (gallbladder volume, baseline - gallbladder volume, at a given time t) / gallbladder volume, baseline * 100. The gallbladder volume is determined by bedside ultrasonography.
15 healthy male subjects will be included according to the inclusion and exclusion criteria listed below.
Inclusion criteria:
Sex: Male Ethnicity: Caucasian Age: 18-35 years BMI: 18.5-24.9 Fasting plasma glucose: 6 mmol/l or below Glycated haemoglobin (HbA1c): 42 mmol/mol or below Haemoglobin: 8.3-10.5 mmol/l
Exclusion criteria:
First-degree relatives with type 1 or type 2 diabetes Nephropathy (serum creatinin > 130 micromole/l) Liver disease Active or recent malignant disease
A subject will participate in three study days (day A, B and C) with a minimum of 48 hours between each day. The three days will differ in regards to the intravenous infusion:
Study day A (placebo):
Subjects arrive at the laboratory after an overnight fast (10h). Two cannulas will then be inserted in the cubital veins (one in each arm) for collection of blood samples and administration of saline (placebo), respectively. The forearm from which blood samples are drawn will be wrapped in a heating pad throughout the experiment. The participant must rest 30 minutes before start of the experimental procedures.
At time -30 min, saline infusion (placebo) will be started.
At time 0 min the participant will ingest a mixed liquid meal (200 ml, 1260 kJ) mixed with paracetamol (1,500 mg) dissolved in 100 ml of water.
At time -60, -30, -15, 0, 10, 30, 50, 70, 90, 120, 150, 180 and 210 min gallbladder height, width and length will be determined by ultrasound (LOGIQ E9, GE Healthcare, Waukesha, WI, USA) for evaluation of gallbladder volume (calculated by the ellipsoid method).
Blood samples will be collected at time -45, -40, -35, -20, -5, 20, 40, 60, 80, 100, 140 and 200 min for the analysis of plasma/serum concentrations of glucose, GLP-1, GLP-2, GIP, glucagon, OXM, PYY, ghrelin, gastrin, CCK, FGF-19, insulin, C-peptide, bile acids, free fatty acids, paracetamol and triglycerides.
Experimental Day B (GLP-2 (1 pmol/kg/min)) As experimental Day A, but with infusion of GLP-2 (1 pmol/kg/min) instead of the saline infusion.
Experimental Day C (GLP-2 (10 pmol/kg/min)) As experimental Day A, but with infusion of GLP-2 (10 pmol/kg/min) instead of the saline infusion.
- Being tested
- GLP-2 (1pmol/kg/min), GLP-2 (10pmol/kg/min), Placebo
- Keywords
- Gallbladder Motility, Gallbladder Emptying, Glucagon-Like Peptide 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-2 (1pmol/kg/min)Drug
Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min
GLP-2 (10pmol/kg/min)Drug
Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10 pmol/kg/min
PlaceboDrug
Four hour intravenous infusion with saline water
| Study group | Role | What they receive |
|---|---|---|
| GLP-2 (10pmol/kg/min) | Experimental | A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10pmol/kg/min Receives: Drug: GLP-2 (10pmol/kg/min) |
| GLP-2 (1pmol/kg/min) | Experimental | A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min Receives: Drug: GLP-2 (1pmol/kg/min) |
| Placebo | Experimental | A single four hour intravenous infusion with saline water (placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gallbladder ejection fraction (EF%)
Incremental Area Under the Curve (iAUC) for gallbladder ejection fraction (EF%) at time 0-210 minutes.
Measured: 0-210 minutes
Secondary outcomes (3)
Glucagon
Incremental Area Under the Curve (iAUC) (-30;200min) of glucagon plasma concentration.
Measured: -30-200 minutes
Gastric emptying
Gastric emptying will be determined by the by paracetamol curve following ingestion of the meal (mixed with 1500 mg paracetamol).
Measured: 0-200 minutes
Time to maximum gallbladder EF%
Time to reach maximum gallbladder ejection fraction.
Measured: 0-210 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 May 2018
- Primary completion30 Aug 2018
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Glucagon-like Peptide 2 on Gallbladder MotilityStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a blinded, randomized, placebo controlled study where 15 participants receive three different 4 hour intravenous infusions of either saline (placebo), low GLP-2 (at a rate of 1pmol/kg/min) or high GLP-2 (at a rate of 10pmol/kg/min) on three different study days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filip K Knop, MD, phd, Principal investigator, Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682172
- Sponsor's protocol ID
- H-17037571
- Status last verified
- Jun 2020
- First submitted
- 16 Jul 2018
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glucagon-like Peptide 2 on Postprandial Gallbladder Motility in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03682172
- Acronym / sponsor ID
- H-17037571
- Keywords
- Gallbladder Motility, Gallbladder Emptying, Glucagon-Like Peptide 2
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 24 Sep 2018 (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 study will investigate the effect of the incretin hormone glucagon-like peptide 2 (GLP-2) on postprandial gallbladder motility in young, healthy, male subjects.
The study is double-blinded, randomized and placebo controlled. 15 subjects will be included. On three separate study days (A, B, C) the subjects will receive an four hour intravenous infusion with either saline (placebo), GLP-2 at a rate of 1 pmol/kg/min or GLP-2 at a rate of 10 pmol/kg/min 30 minutes after the infusion start the subject will receive a liquid meal which will stimulate gallbladder contraction.
The gallbladder volume will be determined by frequent ultrasonic scans, and blood samples will be drawn on fixed times through out the study day.
Detailed description
Study design The primary endpoint is the incremental Area Under the Curve (iAUC) of the gallbladder Ejection Fraction % (EF) at time 0-210 minutes. Gallbladder volume will be measured during a four hour intravenous GLP-2 infusion at two different concentrations (1 pmol/kg body weight/min and 10pmol/kg body weight/min), respectively, compared to placebo after ingestion of a liquid meal in healthy, young, male subjects. The gallbladder volume will be quantified by multiple ultrasonography scans at fixed times during the experimental study days.
Gallbladder ejection fraction (EF%) will be calculated as following:
Gallbladder EF = (gallbladder volume, baseline - gallbladder volume, at a given time t) / gallbladder volume, baseline * 100. The gallbladder volume is determined by bedside ultrasonography.
15 healthy male subjects will be included according to the inclusion and exclusion criteria listed below.
Inclusion criteria:
Sex: Male Ethnicity: Caucasian Age: 18-35 years BMI: 18.5-24.9 Fasting plasma glucose: 6 mmol/l or below Glycated haemoglobin (HbA1c): 42 mmol/mol or below Haemoglobin: 8.3-10.5 mmol/l
Exclusion criteria:
First-degree relatives with type 1 or type 2 diabetes Nephropathy (serum creatinin > 130 micromole/l) Liver disease Active or recent malignant disease
A subject will participate in three study days (day A, B and C) with a minimum of 48 hours between each day. The three days will differ in regards to the intravenous infusion:
Study day A (placebo):
Subjects arrive at the laboratory after an overnight fast (10h). Two cannulas will then be inserted in the cubital veins (one in each arm) for collection of blood samples and administration of saline (placebo), respectively. The forearm from which blood samples are drawn will be wrapped in a heating pad throughout the experiment. The participant must rest 30 minutes before start of the experimental procedures.
At time -30 min, saline infusion (placebo) will be started.
At time 0 min the participant will ingest a mixed liquid meal (200 ml, 1260 kJ) mixed with paracetamol (1,500 mg) dissolved in 100 ml of water.
At time -60, -30, -15, 0, 10, 30, 50, 70, 90, 120, 150, 180 and 210 min gallbladder height, width and length will be determined by ultrasound (LOGIQ E9, GE Healthcare, Waukesha, WI, USA) for evaluation of gallbladder volume (calculated by the ellipsoid method).
Blood samples will be collected at time -45, -40, -35, -20, -5, 20, 40, 60, 80, 100, 140 and 200 min for the analysis of plasma/serum concentrations of glucose, GLP-1, GLP-2, GIP, glucagon, OXM, PYY, ghrelin, gastrin, CCK, FGF-19, insulin, C-peptide, bile acids, free fatty acids, paracetamol and triglycerides.
Experimental Day B (GLP-2 (1 pmol/kg/min)) As experimental Day A, but with infusion of GLP-2 (1 pmol/kg/min) instead of the saline infusion.
Experimental Day C (GLP-2 (10 pmol/kg/min)) As experimental Day A, but with infusion of GLP-2 (10 pmol/kg/min) instead of the saline infusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- It is a blinded, randomized, placebo controlled study where 15 participants receive three different 4 hour intravenous infusions of either saline (placebo), low GLP-2 (at a rate of 1pmol/kg/min) or high GLP-2 (at a rate of 10pmol/kg/min) on three different study days.
| Arm | Type | Receives |
|---|---|---|
| GLP-2 (10pmol/kg/min) | Experimental | Drug: GLP-2 (10pmol/kg/min)A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10pmol/kg/min |
| GLP-2 (1pmol/kg/min) | Experimental | Drug: GLP-2 (1pmol/kg/min)A single four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min |
| Placebo | Experimental | Drug: PlaceboA single four hour intravenous infusion with saline water (placebo) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Caucasian ethnicity
- Male
- Age: 18-35 years
- BMI: 18,5-24,9
- Fasting plasma glucose ≤ 6 mmol/l
Key exclusion criteria (7 listed)
- First-degree relatives with type 1 or type 2 diabetes
- Nephropathy (se-creatinin > 130 μM and/or albuminuria)
- Liver disease (alanintransaminase (ALAT) or aspartattransaminase (ASAT) > 2 × upper normal limit)
- Active or recent malignant disease
- Treatment with medicine that cannot be paused for 1 week
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 |
|---|---|---|
| GLP-2 (1pmol/kg/min)Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min | Drug | GLP-2 (1pmol/kg/min) |
| GLP-2 (10pmol/kg/min)Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10 pmol/kg/min | Drug | GLP-2 (10pmol/kg/min) |
| PlaceboFour hour intravenous infusion with saline water | Drug | Placebo |
Primary outcome
Gallbladder ejection fraction (EF%)
Time frame: 0-210 minutes
Incremental Area Under the Curve (iAUC) for gallbladder ejection fraction (EF%) at time 0-210 minutes.
3 secondary outcomes
Glucagon
Time frame: -30-200 minutes
Gastric emptying
Time frame: 0-200 minutes
Time to maximum gallbladder EF%
Time frame: 0-210 minutes
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 17 Feb 2025.
- Individual participant dataSharing planned: No
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, phd principal investigator
Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GLP-2 (1pmol/kg/min) and GLP-2 (10pmol/kg/min) in people with Effect of Glucagon-like Peptide 2 on Gallbladder Motility, run by Steno Diabetes Center 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 8 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 17 Feb 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gallbladder ejection fraction (EF%) (time frame: 0-210 minutes). 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 17 Feb 2025.