Glucose Metabolism DisordersGA-3NCT03133741
Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist
A study testing GIP-A, GLP-1 receptor antagonist Exendin[9-39] and GIP-A + Exendin[9-39] in people with Glucose Metabolism Disorders, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation. 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
- Glucose Metabolism Disorders
- What is being tested?
- GIP-A, GLP-1 receptor antagonist Exendin[9-39] and GIP-A + Exendin[9-39]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2017to 1 Jul 2017
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal kidney function, liver function and hemoglobin levels.
Who cannot join
- Medication, Diabetes type 1 or 2, first degree relatives with Diabetes type 2
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Diabetes Research
Gentofte Municipality, Copenhagen, 2900
About this study
Official title: Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)
Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.
Read the detailed description
Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR.
Eighteen healthy men (age 18-70 years, BMI 19-35 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin[9-39], C) GIP-A + Exendin[9-39], or D) saline (placebo).
- Conditions
- Glucose Metabolism Disorders
- Being tested
- GIP-A, GLP-1 receptor antagonist Exendin[9-39], Placebo, GIP-A + Exendin[9-39]
- Keywords
- GIP, GIP receptor antagonist
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP-AOther
GIP-A (GIP receptor antagonist)
GLP-1 receptor antagonist Exendin[9-39]Other
Also called EX(9-39)
Exendin[9-39]
PlaceboOther
Also called Saline
Saline (9mg/mL)
GIP-A + Exendin[9-39]Other
GIP receptor antagonist + GLP-1 receptor antagonist
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline Receives: Other: Placebo |
| GIP-A | Other | Infusion of GIP-A alone as study tool. Receives: Other: GIP-A |
| GLP-1 receptor antagonist Exendin[9-39] | Other | Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool. Receives: Other: GLP-1 receptor antagonist Exendin[9-39] |
| GIP-A + Exendin[9-39] | Other | Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools. Receives: Other: GIP-A + Exendin[9-39] |
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)
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Mar 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 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
- NCT03133741
- Sponsor's protocol ID
- UHG-CFD-GIPANTA-3
- Acronym
- GA-3
- Status last verified
- Oct 2017
- First submitted
- 25 Apr 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Helsted MM, Gasbjerg LS, Lanng AR, Bergmann NC, Stensen S, Hartmann B, Christensen MB, Holst JJ, Vilsboll T, Rosenkilde MM, Knop FK. The role of endogenous GIP and GLP-1 in postprandial bone homeostasis. Bone. 2020 Nov;140:115553. doi: 10.1016/j.bone.2020.115553. Epub 2020 Jul 27.
PubMed 32730920Gasbjerg LS, Helsted MM, Hartmann B, Jensen MH, Gabe MBN, Sparre-Ulrich AH, Veedfald S, Stensen S, Lanng AR, Bergmann NC, Christensen MB, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. Separate and Combined Glucometabolic Effects of Endogenous Glucose-Dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1 in Healthy Individuals. Diabetes. 2019 May;68(5):906-917. doi: 10.2337/db18-1123. Epub 2019 Jan 9.
PubMed 30626611
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)
- ClinicalTrials.gov ID
- NCT03133741
- Acronym / sponsor ID
- GA-3 / UHG-CFD-GIPANTA-3
- Conditions
- Glucose Metabolism Disorders
- Keywords
- GIP, GIP receptor antagonist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 28 Apr 2017 (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.
Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.
Detailed description
Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR.
Eighteen healthy men (age 18-70 years, BMI 19-35 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin[9-39], C) GIP-A + Exendin[9-39], 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: PlaceboSaline |
| GIP-A | Other | Other: GIP-AInfusion of GIP-A alone as study tool. |
| GLP-1 receptor antagonist Exendin[9-39] | Other | Other: GLP-1 receptor antagonist Exendin[9-39]Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool. |
| GIP-A + Exendin[9-39] | Other | Other: GIP-A + Exendin[9-39]Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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, first degree relatives with Diabetes type 2
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-A (GIP receptor antagonist) | Other | GIP-A |
| GLP-1 receptor antagonist Exendin[9-39]Also: EX(9-39)Exendin[9-39] | Other | GLP-1 receptor antagonist Exendin[9-39] |
| PlaceboAlso: SalineSaline (9mg/mL) | Other | Placebo |
| GIP-A + Exendin[9-39]GIP receptor antagonist + GLP-1 receptor antagonist | Other | GIP-A + Exendin[9-39] |
Primary outcome
Insulin levels
Time frame: 240 minutes
Serum insulin AUC (area under the curve)
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 1 Nov 2017.
- Derived from this study: PubMed 32730920Helsted MM, Gasbjerg LS, Lanng AR, Bergmann NC, Stensen S, Hartmann B, Christensen MB, Holst JJ, Vilsboll T, Rosenkilde MM, Knop FK. The role of endogenous GIP and GLP-1 in postprandial bone homeostasis. Bone. 2020 Nov;140:115553. doi: 10.1016/j.bone.2020.115553. Epub 2020 Jul 27.
- Derived from this study: PubMed 30626611Gasbjerg LS, Helsted MM, Hartmann B, Jensen MH, Gabe MBN, Sparre-Ulrich AH, Veedfald S, Stensen S, Lanng AR, Bergmann NC, Christensen MB, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. Separate and Combined Glucometabolic Effects of Endogenous Glucose-Dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1 in Healthy Individuals. Diabetes. 2019 May;68(5):906-917. doi: 10.2337/db18-1123. Epub 2019 Jan 9.
- Individual participant dataSharing planned: No
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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, GLP-1 receptor antagonist Exendin[9-39] and GIP-A + Exendin[9-39] in people with Glucose Metabolism Disorders, 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 1 Nov 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: 240 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 NCT03133741, which also lists 2 linked publications.
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 1 Nov 2017.