ObesityEarly Phase 1NCT06368752
The Role of Endogenous GIP in Glycosis Metabolism During Fasting
A Early Phase 1 study testing GIP[3-30]NH2 and Saline in people with Obesity, run by Frederikke Koefoed-Hansen at 1 site in Denmark.
Trial summary
This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP[3-30]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- GIP[3-30]NH2 and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 4 May 2023to 31 Dec 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 years
- BMI > 30 kg/m2
- Body fat percentage > 25 % for men og > 35 % for women
Who cannot join
- Type 1 diabetes and/or type 2 diabetes diagnosis
- Other chronic condition
- Treatment with medications or supplements that cannot be paused for 12 hours
- > 14 units of alcohol weekly or drug abuse
- Circulating liver enzymes (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT)) ≥ 2 × normal value
- Renal impairment (eGFR < 90 or creatinine level above the reference range)
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- Uncontrolled high resting blood pressure (above 140/90 mmHg)
- Low blood percentage (hemoglobin < reference range (different for women and men))
- Special diet or planned weight change within the trial period
- Any disease/condition that investigators believe will interfere with study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GA-18: The Role of Endogenous GIP in Glycosis Metabolism During Fasting
This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP[3-30]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion.
Read the detailed description
This research project investigates the effects endogenous GIP has in the body of healthy, overweight people. Two trial days will be held. The participant will receive intravenous infusion of either GIP[3-30]NH2 (800 pmol/kg/min) or placebo (saline) in a randomized order. After 20 minutes, GIP[3-30]NH2 is expected to have maximum effect. On time of 180 minutes, an ad libitum meal is served, which is consumed during continued infusion. When the participant is comfortably full, the infusion is turned off and the trial day ends. During the day, the participant assesses and notes on standardized VAS schedules current appetite, satiety, nausea, fatigue, malaise and thirst. Blood pressure and heart rate are measured every 30 minutes throughout the trial day and blood samples are taken. In total, there will be drawn ten blood samples between intervals of 15 to 30 min. Three times along the way, the activity in the brown adipose tissue is measured with a thermal camera (temperature measurements over the skin on the chest) and the resting metabolic rate is determined with indirect calorimetry (inhaled and exhaled air is captured by breathing under a large plastic bell).
- Conditions
- Obesity
- Being tested
- GIP[3-30]NH2, Saline
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP[3-30]NH2Biological
GIP[3-30]NH2 is the naturally occurring shorter (truncated) variant of GIP[1-42]. GIP[3-30]NH2 also stimulates the GIP receptor and therefore acts like a GIP receptorantagonist
SalineOther
Sodium chlorid with 0,5% human serum albumin.
| Study group | Role | What they receive |
|---|---|---|
| GIP[3-30]NH2 infusion | Experimental | GIP[3-30]NH2 intravenous infusion (800 pmol/kg/min) Receives: Biological: GIP[3-30]NH2 |
| Saline infusion | Placebo comparator | Saline intravenous infusion (0,5 % human serum albumin) Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucagon concentrations
Measured in mmol/L. The primary endpoint is plasma glucagon concentrations during GIP[3-30]NH2 infusion compared to placebo.Area under the curve (AUC) for plasma glucagon (AUCglucagon) is quantified both as absolute and in baseline-subtracted values (bsAUCglucagon) and the effect of the GIP receptor antagonist will be calculated as a percentage reduction of bsAUC glucagon relative to bsAUC glucagon during the placebo infusion.
Measured: Four hours
Secondary outcomes (7)
Plasma levels of C-peptide
Measured in mmol/L
Measured: Four hours
Plasma levels of insulin
Measured in mmol/L
Measured: Four hours
Resting metabolic rate
Measured in resting energy expenditure (REE) and respiratory quotient (RQ)
Measured: 15 minutes
Activity in brown adipose tissue
Measured by thermal camera
Measured: 10 minutes
Appetite
Measured in kilogram food intake
Measured: 30 minutes
Blood pressure
mmHg
Measured: Pre-intervention at time -30 and -20 min. During infusion at time 0 min, 30 min, 60 min, 90 min, 120 min, 160 min and 180 min.
Puls
Beats pr. minutes
Measured: Pre-intervention at time -30 and -20 minutes. During infusion at time 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 160 minutes, and 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start4 May 2023
- Primary completion12 Dec 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Crossover
- Model description
- The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP\[3-30\]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frederikke Koefoed-Hansen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frederikke Koefoed-Hansen, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368752
- Sponsor's protocol ID
- H-22063621
- Status last verified
- Apr 2024
- First submitted
- 30 Jul 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this project or sub-elements of the project will be compiled into one or more manuscripts for publication in one or more international scientific high impact journals. All results, both inconclusive, negative and positive trial results, will be published as soon as possible. All trial participants will be informed in writing of the results after the end of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GA-18: The Role of Endogenous GIP in Glycosis Metabolism During Fasting
- ClinicalTrials.gov ID
- NCT06368752
- Acronym / sponsor ID
- H-22063621
- Conditions
- Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Frederikke Koefoed-HansenUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Apr 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.
This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP[3-30]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion.
Detailed description
This research project investigates the effects endogenous GIP has in the body of healthy, overweight people. Two trial days will be held. The participant will receive intravenous infusion of either GIP[3-30]NH2 (800 pmol/kg/min) or placebo (saline) in a randomized order. After 20 minutes, GIP[3-30]NH2 is expected to have maximum effect. On time of 180 minutes, an ad libitum meal is served, which is consumed during continued infusion. When the participant is comfortably full, the infusion is turned off and the trial day ends. During the day, the participant assesses and notes on standardized VAS schedules current appetite, satiety, nausea, fatigue, malaise and thirst. Blood pressure and heart rate are measured every 30 minutes throughout the trial day and blood samples are taken. In total, there will be drawn ten blood samples between intervals of 15 to 30 min. Three times along the way, the activity in the brown adipose tissue is measured with a thermal camera (temperature measurements over the skin on the chest) and the resting metabolic rate is determined with indirect calorimetry (inhaled and exhaled air is captured by breathing under a large plastic bell).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP[3-30]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo).
| Arm | Type | Receives |
|---|---|---|
| GIP[3-30]NH2 infusion | Experimental | Biological: GIP[3-30]NH2GIP[3-30]NH2 intravenous infusion (800 pmol/kg/min) |
| Saline infusion | Placebo comparator | Other: SalineSaline intravenous infusion (0,5 % human serum albumin) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years
- BMI > 30 kg/m2
- Body fat percentage > 25 % for men og > 35 % for women
Key exclusion criteria (10 listed)
- Type 1 diabetes and/or type 2 diabetes diagnosis
- Other chronic condition
- Treatment with medications or supplements that cannot be paused for 12 hours
- > 14 units of alcohol weekly or drug abuse
- Circulating liver enzymes (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT)) ≥ 2 × normal value
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 |
|---|---|---|
| GIP[3-30]NH2GIP[3-30]NH2 is the naturally occurring shorter (truncated) variant of GIP[1-42]. GIP[3-30]NH2 also stimulates the GIP receptor and therefore acts like a GIP receptorantagonist | Biological | GIP[3-30]NH2 infusion |
| SalineSodium chlorid with 0,5% human serum albumin. | Other | Saline infusion |
Primary outcome
Plasma glucagon concentrations
Time frame: Four hours
Measured in mmol/L. The primary endpoint is plasma glucagon concentrations during GIP[3-30]NH2 infusion compared to placebo.Area under the curve (AUC) for plasma glucagon (AUCglucagon) is quantified both as absolute and in baseline-subtracted values (bsAUCglucagon) and the effect of the GIP receptor antagonist will be calculated as a percentage reduction of bsAUC glucagon relative to bsAUC glucagon during the placebo infusion.
7 secondary outcomes
Plasma levels of C-peptide
Time frame: Four hours
Plasma levels of insulin
Time frame: Four hours
Resting metabolic rate
Time frame: 15 minutes
Activity in brown adipose tissue
Time frame: 10 minutes
Appetite
Time frame: 30 minutes
Blood pressure
Time frame: Pre-intervention at time -30 and -20 min. During infusion at time 0 min, 30 min, 60 min, 90 min, 120 min, 160 min and 180 min.
Puls
Time frame: Pre-intervention at time -30 and -20 minutes. During infusion at time 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 160 minutes, and 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Yes. The results of this project or sub-elements of the project will be compiled into one or more manuscripts for publication in one or more international scientific high impact journals. All results, both inconclusive, negative and positive trial results, will be published as soon as possible. All trial participants will be informed in writing of the results after the end of the trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 GIP[3-30]NH2 and Saline in people with Obesity, run by Frederikke Koefoed-Hansen 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 3 inclusion and 10 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 16 Apr 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?
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?
Results are not available in the source record.
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?
Plasma glucagon concentrations (time frame: Four hours). 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 16 Apr 2024.