Glucose MetabolismGA-1NCT02747472
GIP Receptor Antagonist Studies in Humans
A study testing GIP-A, GIP(1-42) and Saline in people with Glucose Metabolism, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism
- What is being tested?
- GIP-A, GIP(1-42) and Saline
- 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
- Apr 2016to Jul 2016
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal kidney function, liver function and hemoglobin levels.
Who cannot join
- Medication, Diabetes type 1 or 2, BMI > 25, first degree relatives with Type 2 Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans
Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.
Read the detailed description
Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.
The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C) GIP[1-42] + GIP-A, or D) saline (placebo).
- Conditions
- Glucose Metabolism
- Being tested
- GIP-A, GIP(1-42), Saline
- Keywords
- GIP, GIP receptor antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP-ADrug
GIP receptor antagonist
GIP(1-42)Drug
GIP receptor agonist
SalineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Infusion of saline Receives: Other: Saline |
| GIP(1-42) | Active comparator | Infusion of agonist, GIP(1-42) Receives: Drug: GIP(1-42) |
| GIP-A | Experimental | Infusion of GIP-A alone Receives: Drug: GIP-A |
| GIP-A + GIP(1-42) | Experimental | Infusion of GIP-A and GIP(1-42) Receives: Drug: GIP-A; Drug: GIP(1-42) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin levels
Serum-insulin AUC (area under the curve for hyperglycemic clamp period)
Measured: 65 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glucose MetabolismStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Lærke Smidt Gasbjerg, University Hospital, Gentofte, Copenhagen
- Investigators
- Filip K Knop, MD, PhD, Study director, UHGentofte, Center for Diabetes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747472
- Sponsor's protocol ID
- UHG-CFD-GIPANTA-1
- Acronym
- GA-1
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gasbjerg LS, Christensen MB, Hartmann B, Lanng AR, Sparre-Ulrich AH, Gabe MBN, Dela F, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. GIP(3-30)NH2 is an efficacious GIP receptor antagonist in humans: a randomised, double-blinded, placebo-controlled, crossover study. Diabetologia. 2018 Feb;61(2):413-423. doi: 10.1007/s00125-017-4447-4. Epub 2017 Sep 25.
PubMed 28948296
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans
- ClinicalTrials.gov ID
- NCT02747472
- Acronym / sponsor ID
- GA-1 / UHG-CFD-GIPANTA-1
- Conditions
- Glucose Metabolism
- Keywords
- GIP, GIP receptor antagonist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Apr 2016 (estimated)
- 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.
Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.
Detailed description
Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.
The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C) GIP[1-42] + GIP-A, or D) saline (placebo).
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 |
|---|---|---|
| Placebo | Placebo comparator | Other: SalineInfusion of saline |
| GIP(1-42) | Active comparator | Drug: GIP(1-42)Infusion of agonist, GIP(1-42) |
| GIP-A | Experimental | Drug: GIP-AInfusion of GIP-A alone |
| GIP-A + GIP(1-42) | Experimental | Drug: GIP-A, Drug: GIP(1-42)Infusion of GIP-A and GIP(1-42) |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal kidney function, liver function and hemoglobin levels.
Key exclusion criteria (1 listed)
- Medication, Diabetes type 1 or 2, BMI > 25, first degree relatives with Type 2 Diabetes
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-AGIP receptor antagonist | Drug | GIP-A, GIP-A + GIP(1-42) |
| GIP(1-42)GIP receptor agonist | Drug | GIP(1-42), GIP-A + GIP(1-42) |
| SalinePlacebo | Other | Placebo |
Primary outcome
Insulin levels
Time frame: 65 minutes
Serum-insulin AUC (area under the curve for hyperglycemic clamp period)
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 27 Apr 2017.
- Derived from this study: PubMed 28948296Gasbjerg LS, Christensen MB, Hartmann B, Lanng AR, Sparre-Ulrich AH, Gabe MBN, Dela F, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. GIP(3-30)NH2 is an efficacious GIP receptor antagonist in humans: a randomised, double-blinded, placebo-controlled, crossover study. Diabetologia. 2018 Feb;61(2):413-423. doi: 10.1007/s00125-017-4447-4. Epub 2017 Sep 25.
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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 K Knop, MD, PhD study director
UHGentofte, Center for Diabetes 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 GIP-A, GIP(1-42) and Saline in people with Glucose Metabolism, 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 1 inclusion and 1 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 27 Apr 2017. 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.
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?
Insulin levels (time frame: 65 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747472, which also lists 1 linked publication.
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 27 Apr 2017.