Effect of iv Administration of GIP and AlaninePhase 1GIPALANINNCT06419686
The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
A Phase 1 study testing GIP, Alanine and GIP + alanine in people with Effect of iv Administration of GIP and Alanine, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of iv Administration of GIP and Alanine
- What is being tested?
- GIP, Alanine and GIP + alanine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to Jul 2024
- Phase
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian ethnicity
- Body mass index (BMI) 20-27 kg/m^2
- Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
- Informed and written consent
Who cannot join
- Late microvascular complications except mild nonproliferative retinopathy
- Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder
- Treatment with any glucose-lowering drugs
- Active or recent (within 5 years) malignant disease
- Active tobacco smoking/use
- Any condition considered incompatible with participation by the investigators.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, 2900
Filip K. Knop, MD, PhD, +4526830161, filip.krag.knop.01@regionh.dk
Julie V. Warnøe, MD
About this study
Official title: The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
The study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine.
The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids.
- Being tested
- Placebo (saline), GIP, Alanine, GIP + alanine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (saline)Other
Intravenous saline during experimental days.
GIPDrug
Intravenous GIP administration during experimental days.
AlanineDrug
Intravenous alanine administration during experimental days.
GIP + alanineDrug
Intravenous administration of GIP and alanine during experimental days.
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Intravenous administration of saline for 90 minutes. Receives: Other: Placebo (saline) |
| GIP | Experimental | Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes. Receives: Drug: GIP |
| Alanine | Experimental | Intravenous administration of alanine for 90 minutes (28 umol/kg/min). Receives: Drug: Alanine |
| GIP + Alanine | Experimental | Intravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes. Receives: Drug: GIP + alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of Glucagon
Baseline
Measured: Timepoint -30 to 90 minutes
Plasma concentrations of Glucagon
Baseline-corrected area under the curve (bsAUC)
Measured: Timepoint -30 to 90 minutes
Secondary outcomes (23)
Serum concentration of Insulin
Baseline
Measured: Timepoint -30 to 90 minutes
Serum concentration of Insulin
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Serum concentration of C-peptid
Baseline
Measured: Timepoint -30 to 90 minutes
Serum concentration of C-peptid
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Baseline
Measured: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Peak value
Measured: Timepoint -30 to 90 minutes
Plasma concentration of GIP
Baseline
Measured: Timepoint -30 to 90 minutes
Plasma concentration of GIP
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Circulating levels of total amino acids
Baseline
Measured: Timepoint -30 to 90 minutes
Circulating levels of total amino acids
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Circulating levels of individual amino acids
Baseline
Measured: Timepoint -30 to 90 minutes
Circulating levels of individual amino acids
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Lipid profile
Baseline
Measured: Timepoint -30 to 90 minutes
Lipid profile
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Circulating levels of CTx
Baseline
Measured: Timepoint -30 to 90 minutes
Circulating levels of CTx
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Circulating levels of P1NP
Baseline
Measured: Timepoint -30 to 90 minutes
Circulating levels of P1NP
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30 to 90 minutes
Blood pressure
Baseline
Measured: Timepoint -30, 0, 30, 60, 90
Blood pressure
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30, 0, 30, 60, 90
Pulse
Baseline
Measured: Timepoint -30, 0, 30, 60, 90
Pulse
Baseline-corrected area under the curve (bsAUC).
Measured: Timepoint -30, 0, 30, 60, 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Jan 2024
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of iv Administration of GIP and AlanineStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
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 K Knop, MD, PhD, Principal investigator, Center for Clinical Metabolic Research, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419686
- Sponsor's protocol ID
- H-21066812
- Acronym
- GIPALANIN
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 17 May 2024
- 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06419686
- Acronym / sponsor ID
- GIPALANIN / H-21066812
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 17 May 2024 (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 is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine.
The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Other: Placebo (saline)Intravenous administration of saline for 90 minutes. |
| GIP | Experimental | Drug: GIPIntravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes. |
| Alanine | Experimental | Drug: AlanineIntravenous administration of alanine for 90 minutes (28 umol/kg/min). |
| GIP + Alanine | Experimental | Drug: GIP + alanineIntravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caucasian ethnicity
- Body mass index (BMI) 20-27 kg/m^2
- Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
- Informed and written consent
Key exclusion criteria (6 listed)
- Late microvascular complications except mild nonproliferative retinopathy
- Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder
- Treatment with any glucose-lowering drugs
- Active or recent (within 5 years) malignant disease
- Active tobacco smoking/use
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 |
|---|---|---|
| Placebo (saline)Intravenous saline during experimental days. | Other | Saline |
| GIPIntravenous GIP administration during experimental days. | Drug | GIP |
| AlanineIntravenous alanine administration during experimental days. | Drug | Alanine |
| GIP + alanineIntravenous administration of GIP and alanine during experimental days. | Drug | GIP + Alanine |
Primary outcome
Plasma concentrations of Glucagon
Time frame: Timepoint -30 to 90 minutes
Baseline
Plasma concentrations of Glucagon
Time frame: Timepoint -30 to 90 minutes
Baseline-corrected area under the curve (bsAUC)
23 secondary outcomes
Serum concentration of Insulin
Time frame: Timepoint -30 to 90 minutes
Serum concentration of Insulin
Time frame: Timepoint -30 to 90 minutes
Serum concentration of C-peptid
Time frame: Timepoint -30 to 90 minutes
Serum concentration of C-peptid
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of glucose
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of GIP
Time frame: Timepoint -30 to 90 minutes
Plasma concentration of GIP
Time frame: Timepoint -30 to 90 minutes
Circulating levels of total amino acids
Time frame: Timepoint -30 to 90 minutes
Circulating levels of total amino acids
Time frame: Timepoint -30 to 90 minutes
Circulating levels of individual amino acids
Time frame: Timepoint -30 to 90 minutes
Circulating levels of individual amino acids
Time frame: Timepoint -30 to 90 minutes
Lipid profile
Time frame: Timepoint -30 to 90 minutes
Lipid profile
Time frame: Timepoint -30 to 90 minutes
Circulating levels of CTx
Time frame: Timepoint -30 to 90 minutes
Circulating levels of CTx
Time frame: Timepoint -30 to 90 minutes
Circulating levels of P1NP
Time frame: Timepoint -30 to 90 minutes
Circulating levels of P1NP
Time frame: Timepoint -30 to 90 minutes
Blood pressure
Time frame: Timepoint -30, 0, 30, 60, 90
Blood pressure
Time frame: Timepoint -30, 0, 30, 60, 90
Pulse
Time frame: Timepoint -30, 0, 30, 60, 90
Pulse
Time frame: Timepoint -30, 0, 30, 60, 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- 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
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?
A Phase 1 study testing GIP, Alanine and GIP + alanine in people with Effect of iv Administration of GIP and Alanine, 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 6 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: status not confirmed, as of the sponsor's last update on 17 May 2024. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie V Warnøe, MD (+4527282263, julie.vilhelmine.warnoee.nielsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentrations of Glucagon (time frame: Timepoint -30 to 90 minutes). The study lists 2 primary outcomes in all. 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 May 2024.