Glucose Metabolism DisordersGLANCENCT03954873
Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
A study testing Glucagon-like peptide 2, Saline and Glucose in people with Glucose Metabolism Disorders and Endocrine or Metabolic Disease, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Infusion of glucagon-like peptide 2 (GLP-2) during euglycaemia, hypoglycaemia and hyperglycaemia and evaluation of the effect on glucagon secretion in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders, Endocrine or Metabolic Disease
- What is being tested?
- Glucagon-like peptide 2, Saline and Glucose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Jan 2019to 1 Jun 2020
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian ethnicity
- Body mass index (BMI): 18.5-27 kg/m2
- Glycated haemoglobin (HbA1c) < 42 mmol/mol
- Normal haemoglobin (8.3-10.5 mmol/l)
- Informed and oral and written consent
Who cannot join
- Prediabetes, type 1 diabetes or type 2 diabetes or first-degree relatives with type 1 or type 2 diabetes
- Nephropathy (eGFR < 60 and/or albuminuria)
- Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) > 2 × upper normal limit
- Bilirubin > 25 μmol/l
- Known intestinal disease or previous surgery of the intestines
- Active or recent malignant disease
- Treatment with medicine that cannot be paused for 12 hours
- Any condition considered incompatible with participation by the investigators
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research
Hellerup, Copenhagen, 2900
About this study
Infusion of glucagon-like peptide 2 (GLP-2) during euglycaemia, hypoglycaemia and hyperglycaemia and evaluation of the effect on glucagon secretion in healthy subjects.
Read the detailed description
This is a cross-over, randomized, double-blinded study in which 10 participants will undergo 6 experimental days each. The participants will have their plasma glucose clamped at either euglycaemia (fasting level), hypoglycemia (2,5 mmol/l) or hyperglycemia (10 mmol/l) during infusion of GLP-2 or saline (placebo)
The six days will be as follows:
- Euglycaemia + Placebo
- Euglycaemia + GLP-2
- Hyperglycaemia + Placebo
- Hyperglycaemia + GLP-2
- Hypoglycaemia + Placebo
- Hypoglycaemia + GLP-2
The primary endpoint will be levels of plasma glucagon. Secondary endpoint will be levels of GLP-1, GLP-2, Insulin/C-peptide, OXM, Amino acids, CCK, Gastrin, norepinephrine, bile acids, FGF-19/FGF-21. Secondary endpoints will also include ultrasound scan of the gallbladder.
- Being tested
- Glucagon-like peptide 2, Saline, Glucose, Insulin
- Keywords
- GLP-2, Glucagon
- Medical subject headings
- Glucose Metabolism Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-like peptide 2Other
Human glucagon-like peptide 2
SalineOther
Placebo
GlucoseOther
20% (w/v) glucose infusion for regulating plasma glucose
InsulinOther
Actrapid (insulin) for lowering plasma glucose
| Study group | Role | What they receive |
|---|---|---|
| Hyperglycaemia + GLP-2 | Experimental | Glucose + GLP-2 Receives: Other: Glucagon-like peptide 2; Other: Glucose |
| Hyperglycaemia + Placebo | Active comparator | Glucose + saline Receives: Other: Saline; Other: Glucose |
| Hypoglycaemia + GLP-2 | Experimental | Insulin + glucose + GLP-2 Receives: Other: Glucagon-like peptide 2; Other: Glucose; Other: Insulin |
| Hypoglycaemia + Saline | Active comparator | Insulin + glucose Receives: Other: Saline; Other: Glucose; Other: Insulin |
| Euglycaemia + GLP-2 | Experimental | GLP-2 Receives: Other: Glucagon-like peptide 2 |
| Euglycaemia + Placebo | Active comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucagon secretion
Assessed by difference in absolute plasma glucagon concentrations (measured in pmol/liter) and incremental (baseline-subtracted) area under curve (AUC) for plasma glucagon
Measured: 110 minutes
Secondary outcomes (21)
Plasma glucose
Measured in mmol/liter
Measured: 110 minutes
GLP-1
Glucagon-like peptide 1, Measured in pmol/liter
Measured: 110 minutes
GLP-2
Glucagon-like peptide 2, Measured in pmol/liter
Measured: 110 minutes
Insulin
Measured in pmol/liter
Measured: 110 minutes
GIP
Glucose dependent insulinotropic hormone, Measured in pmol/liter
Measured: 110 minutes
OXM
Oxytomodulin, Measured in pmol/liter
Measured: 110 minutes
Amino acids
Measured in pmol/liter
Measured: 110 minutes
CCK
Cholecystokinin, Measured in pmol/liter
Measured: 110 minutes
Gastrin
Measured in pmol/liter
Measured: 110 minutes
FGF-19
Fibroblast Growth factor 19, Measured in ng/mL
Measured: 110 minutes
FGF-21
Fibroblast Growth factor 21, Measured in ng/mL
Measured: 110 minutes
Bile acids
Measured in nmol/ml
Measured: 110 minutes
Norepinephrine
Measured in pmol/liter
Measured: 110 minutes
GH
Growth hormone, Measured in nmol/ml
Measured: 110 minutes
P1NP
Procollagen type I N-terminal propeptide (Bonemarker), Measured in nmol/ml
Measured: 110 minutes
CTX
C-terminal telopeptide (Bonemarker), Measured in nmol/ml
Measured: 110 minutes
Gallbladder ultrasound
Measuring of gallbladder size in respons to GLP-2
Measured: 110 minutes
Glucose infusion
Amount of glucose infusion (20% v/w) in milliliters needed to clamp at isoglycemic levels (hyperglycemia and hypoglycemia) in respons to GLP-2
Measured: 90 minutes
Blood pressure
Systolic (mmHg) and diastolic (mmHg) blood pressure in respons to GLP-2
Measured: 110 minutes
Heart rate
Heart rate (beats/minutes) in respons to GLP-2
Measured: 110 minutes
C-peptide
Measured in pmol/liter
Measured: 110 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start31 Jan 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip Krag Knop, MD, PhD, Study director, Center for Clinical Metabolic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954873
- Sponsor's protocol ID
- H-18046965
- Acronym
- GLANCE
- Status last verified
- Nov 2020
- First submitted
- 15 May 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers unless data management agreements are signed.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
- ClinicalTrials.gov ID
- NCT03954873
- Acronym / sponsor ID
- GLANCE / H-18046965
- Keywords
- GLP-2, Glucagon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 17 May 2019 (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.
Infusion of glucagon-like peptide 2 (GLP-2) during euglycaemia, hypoglycaemia and hyperglycaemia and evaluation of the effect on glucagon secretion in healthy subjects.
Detailed description
This is a cross-over, randomized, double-blinded study in which 10 participants will undergo 6 experimental days each. The participants will have their plasma glucose clamped at either euglycaemia (fasting level), hypoglycemia (2,5 mmol/l) or hyperglycemia (10 mmol/l) during infusion of GLP-2 or saline (placebo)
The six days will be as follows:
- Euglycaemia + Placebo
- Euglycaemia + GLP-2
- Hyperglycaemia + Placebo
- Hyperglycaemia + GLP-2
- Hypoglycaemia + Placebo
- Hypoglycaemia + GLP-2
The primary endpoint will be levels of plasma glucagon. Secondary endpoint will be levels of GLP-1, GLP-2, Insulin/C-peptide, OXM, Amino acids, CCK, Gastrin, norepinephrine, bile acids, FGF-19/FGF-21. Secondary endpoints will also include ultrasound scan of the gallbladder.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Hyperglycaemia + GLP-2 | Experimental | Other: Glucagon-like peptide 2, Other: GlucoseGlucose + GLP-2 |
| Hyperglycaemia + Placebo | Active comparator | Other: Saline, Other: GlucoseGlucose + saline |
| Hypoglycaemia + GLP-2 | Experimental | Other: Glucagon-like peptide 2, Other: Glucose, Other: InsulinInsulin + glucose + GLP-2 |
| Hypoglycaemia + Saline | Active comparator | Other: Saline, Other: Glucose, Other: InsulinInsulin + glucose |
| Euglycaemia + GLP-2 | Experimental | Other: Glucagon-like peptide 2GLP-2 |
| Euglycaemia + Placebo | Active comparator | Other: Saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian ethnicity
- Body mass index (BMI): 18.5-27 kg/m2
- Glycated haemoglobin (HbA1c) < 42 mmol/mol
- Normal haemoglobin (8.3-10.5 mmol/l)
- Informed and oral and written consent
Key exclusion criteria (8 listed)
- Prediabetes, type 1 diabetes or type 2 diabetes or first-degree relatives with type 1 or type 2 diabetes
- Nephropathy (eGFR < 60 and/or albuminuria)
- Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) > 2 × upper normal limit
- Bilirubin > 25 μmol/l
- Known intestinal disease or previous surgery of the intestines
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 |
|---|---|---|
| Glucagon-like peptide 2Human glucagon-like peptide 2 | Other | Euglycaemia + GLP-2, Hyperglycaemia + GLP-2, Hypoglycaemia + GLP-2 |
| SalinePlacebo | Other | Euglycaemia + Placebo, Hyperglycaemia + Placebo, Hypoglycaemia + Saline |
| Glucose20% (w/v) glucose infusion for regulating plasma glucose | Other | Hyperglycaemia + GLP-2, Hyperglycaemia + Placebo, Hypoglycaemia + GLP-2, Hypoglycaemia + Saline |
| InsulinActrapid (insulin) for lowering plasma glucose | Other | Hypoglycaemia + GLP-2, Hypoglycaemia + Saline |
Primary outcome
Glucagon secretion
Time frame: 110 minutes
Assessed by difference in absolute plasma glucagon concentrations (measured in pmol/liter) and incremental (baseline-subtracted) area under curve (AUC) for plasma glucagon
21 secondary outcomes
Plasma glucose
Time frame: 110 minutes
GLP-1
Time frame: 110 minutes
GLP-2
Time frame: 110 minutes
Insulin
Time frame: 110 minutes
GIP
Time frame: 110 minutes
OXM
Time frame: 110 minutes
Amino acids
Time frame: 110 minutes
CCK
Time frame: 110 minutes
Gastrin
Time frame: 110 minutes
FGF-19
Time frame: 110 minutes
FGF-21
Time frame: 110 minutes
Bile acids
Time frame: 110 minutes
Norepinephrine
Time frame: 110 minutes
GH
Time frame: 110 minutes
P1NP
Time frame: 110 minutes
CTX
Time frame: 110 minutes
Gallbladder ultrasound
Time frame: 110 minutes
Glucose infusion
Time frame: 90 minutes
Blood pressure
Time frame: 110 minutes
Heart rate
Time frame: 110 minutes
C-peptide
Time frame: 110 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 4 Nov 2020.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers unless data management agreements are signed.
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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 Krag Knop, MD, PhD study director
Center for Clinical Metabolic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon-like peptide 2, Saline and Glucose in people with Glucose Metabolism Disorders and Endocrine or Metabolic Disease, 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 5 inclusion and 8 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 4 Nov 2020. 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?
Glucagon secretion (time frame: 110 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 4 Nov 2020.