Acromegaly Due to Pituitary AdenomaGA-9NCT03807076
Modulating the GIP System in Patients With Acromegaly Due to a Pituitary Tumor
A study testing GIP-A in people with Acromegaly Due to Pituitary Adenoma, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acromegaly Due to Pituitary Adenoma
- What is being tested?
- GIP-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Aug 2019to 28 Nov 2023
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under clinical investigation of acromegaly disease with normal kidney function, liver function and hemoglobin levels.
Who cannot join
- Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (>170/100 mmHg), current pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
Read the detailed description
Aim: To determine the importance of the GIP system in patients with acromegaly who has paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP antagonist (GIP-A).
Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin levels will be included in a placebo-controlled cross-over study. The study consists of two study days with concomitant infusions of A) GIP-A or B) saline (placebo).
A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the literature.
Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J Clin Endocrinol Metab 104(3), 856-862
- Conditions
- Acromegaly Due to Pituitary Adenoma
- Being tested
- GIP-A, Placebo
- Medical subject headings
- Growth Hormone-Secreting Pituitary Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP-AOther
GIP-A
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GIP-A | Other | Infusion of GIP-A alone as a study tool. Receives: Other: GIP-A |
| Placebo | Placebo comparator | Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth hormone levels
Plasma growth hormone area under the curve (AUC)
Measured: 240 min
Secondary outcomes (14)
Glucose levels
Plasma glucose AUC
Measured: 240 min
GIP levels
Plasma GIP AUC
Measured: 240 min
Insulin levels
Serum insulin AUC
Measured: 240 min
C-peptide levels
Serum C-peptide AUC
Measured: 240 min
Insulin-like growth factor-1 (IGF-1) levels
Plasma IGF-1 AUC
Measured: 240 min
Free fatty acids (FFA) levels
serum FFA AUC
Measured: 240 min
Glucagon levels
plasma glucagon AUC
Measured: 240 min
Ghrelin levels
plasma ghrelin AUC
Measured: 240 min
GLP-1 levels
Plasma GLP-1 AUC
Measured: 240 min
GLP-2 levels
Plasma GLP-2 AUC
Measured: 240 min
Plasma cholesterol
Plasma cholesterol AUC
Measured: 240 min
Plasma triglyceride
Plasma triglyceride AUC
Measured: 240 min
Plasma TSH
Plasma TSH AUC
Measured: 240 min
Plasma prolactin
Plasma prolactin AUC
Measured: 240 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start13 Aug 2019
- Primary completion14 Jun 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromegaly Due to Pituitary AdenomaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Herlev and Gentofte Hospital
- Responsible party
- Principal investigator, Mette Høy Jensen, University of Copenhagen
- Investigators
- Mette H Jensen, MSc, Principal investigator, Department of Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807076
- Sponsor's protocol ID
- Acromegaly GA-9
- Acronym
- GA-9
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating the Glucose-dependent Insulinotropic Polypeptide (GIP) System in Patients With Acromegaly Due to a Pituitary Tumor
- ClinicalTrials.gov ID
- NCT03807076
- Acronym / sponsor ID
- GA-9 / Acromegaly GA-9
- Conditions
- Acromegaly Due to Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Aarhus University Hospital, Aalborg University Hospital, Odense University Hospital, Herlev and Gentofte Hospital
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 16 Jan 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.
Modulation of the GIP System in Patients With Acromegaly Due to a Pituitary adenoma
Detailed description
Aim: To determine the importance of the GIP system in patients with acromegaly who has paradoxical growth hormone secretion during an oral glucose tolerance test (OGTT) using a GIP antagonist (GIP-A).
Thirty participants (age 18-75 years) with normal kidney and liver parameters and hemoglobin levels will be included in a placebo-controlled cross-over study. The study consists of two study days with concomitant infusions of A) GIP-A or B) saline (placebo).
A paradoxical growth hormone secretion to an OGTT is here defined as an increase in plasma growth hormone levels of ≥30% from baseline based on a mean value of the definitions in the literature.
Regazzo et al. (2017) European Journal of Endocrinology 176, 543-553 Mukai et al. (2018) The Journal of Clinical Endocrinology and Metabolism 104(5), 1637-1644 Hage et al. (2019) The Journal of Clinical Endocrinology and Metabolism 104(5), 1777-1787 Scaroni et al. (2019) J Clin Endocrinol Metab 104(3), 856-862
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIP-A | Other | Other: GIP-AInfusion of GIP-A alone as a study tool. |
| Placebo | Placebo comparator | Other: PlaceboSaline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients under clinical investigation of acromegaly disease with normal kidney function, liver function and hemoglobin levels.
Key exclusion criteria (1 listed)
- Medication for acromegaly, adenectomy, liver disease, uncontrolled anemia, severe heart disease, uncontrolled high blood pressure (>170/100 mmHg), current pregnancy
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 | Other | GIP-A |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Growth hormone levels
Time frame: 240 min
Plasma growth hormone area under the curve (AUC)
14 secondary outcomes
Glucose levels
Time frame: 240 min
GIP levels
Time frame: 240 min
Insulin levels
Time frame: 240 min
C-peptide levels
Time frame: 240 min
Insulin-like growth factor-1 (IGF-1) levels
Time frame: 240 min
Free fatty acids (FFA) levels
Time frame: 240 min
Glucagon levels
Time frame: 240 min
Ghrelin levels
Time frame: 240 min
GLP-1 levels
Time frame: 240 min
GLP-2 levels
Time frame: 240 min
Plasma cholesterol
Time frame: 240 min
Plasma triglyceride
Time frame: 240 min
Plasma TSH
Time frame: 240 min
Plasma prolactin
Time frame: 240 min
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 29 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Acromegaly Due to Pituitary Adenoma
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Not yet recruitingPhase 3
PRESTO: A Phase III Randomised Controlled Trial of Dose-escalated Proton Beam Therapy Versus Standard of Care Radiotherapy for Functioning Pituitary Tumours
Acromegaly Due to Pituitary Adenoma, Cushing's Disease
Not yet recruitingObservational study
Ultrasound in Predicting Difficult Intubation in Acromegaly Patients
Acromegaly Due to Pituitary Adenoma, Difficult Intubation
RecruitingObservational study
Effects of Pasireotide Lar Therapy on Bone Metabolism
Acromegaly Due to Pituitary Adenoma, Acromegaly
Recruiting
KETOgenic Diet Therapy in Patients With ACROmegaly
Acromegaly Due to Pituitary Adenoma, Ketogenic Diet
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.
Mette H Jensen, MSc principal investigator
Department of Biomedical Sciences
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 in people with Acromegaly Due to Pituitary Adenoma, run by University of 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 29 Nov 2023. 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?
Growth hormone levels (time frame: 240 min). 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 29 Nov 2023.