Diabetes Mellitus, Type 2iPAVENCT03923114
Imaging Pituitary ActiVation by Exendin
A study testing Ga-68-NODAGA-exendin-4 PET/CT in people with Diabetes Mellitus, Type 2, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The main goal is the comparison of pituitary uptake of Ga-68-NODAGA-exendin-4 in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ga-68-NODAGA-exendin-4 PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 May 2019to 3 Apr 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with treatment response:
- Age ≥18 years
- Subject is diagnosed with type 2 diabetes
- Subject showed response to GLP-1RA treatment
- Ability to sign informed consent
- Patients without treatment response:
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- Age ≥18 years
- Subject is diagnosed with type 2 diabetes
- Subject showed no response to GLP-1RA treatment
- Ability to sign informed consent
Who cannot join
- Liver disease
- Renal disease
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- Age <18 years
- Pituitary disorder
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- Inability to sign informed consent
- Fragments, clips or devices in brain, eyes, spinal canal
- Implantable defibrillator or pacemaker (wires)
- Mandibular magnetic implants
- Neurostimulator, bladder stimulator, non-removable insulin pump
- Metal tissue-expander in chest
- Cochlear implant
- Ossicular replacement prosthesis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
About this study
Official title: iPAVE - Imaging Pituitary ActiVation by Exendin
The main goal is the comparison of pituitary uptake of Ga-68-NODAGA-exendin-4 in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.
Read the detailed description
The prevalence of type 2 diabetes (T2D) is increasing and a better understanding of the mechanisms of T2D becomes increasingly important. The glucagon-like peptide 1 receptor agonists (GLP-1RA), such as exendin, can be used as potent antidiabetic drugs for treatment of T2D. Not all patients with T2D respond to treatment with GLP-1RA and some even respond with contradictory effects, but the underlying mechanism for this observation remains unclear. Interestingly, uptake of an exendin-based radiotracer was observed in the pituitary gland in diabetes patients. In this study, the effect of GLP-1RA on the HPA axis will be further studied for an improved understanding of the mechanisms and contradictory treatment responses.
Patient data will be obtained and will consist of metabolic characterization (laboratory parameters and oral glucose tolerance test), an ACTH assay and determination of cortisol excretion. In addition, Ga-68-NODAGA-exendin-4 PET/CT imaging will be performed in 10 patients with treatment response (decrease in HbA1c or weight loss) and 10 patients without response after GLP-1RA therapy. In 5 patients with high radiotracer uptake, an additional brain MRI scan will be performed for improved anatomical referencing.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Ga-68-NODAGA-exendin-4 PET/CT
- Keywords
- exendin, GLP-1 receptor agonist, HPA-axis, Imaging
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68-NODAGA-exendin-4 PET/CTRadiation
PET/CT imaging after injection with Ga-68-NODAGA-exendin-4
| Study group | Role | What they receive |
|---|---|---|
| Patient group with treatment response | Other | PET/CT imaging of patients with response to GLP-1 receptor agonist treatment Receives: Radiation: Ga-68-NODAGA-exendin-4 PET/CT |
| Patient group without treatment response | Other | PET/CT imaging of patients with no response to GLP-1 receptor agonist treatment Receives: Radiation: Ga-68-NODAGA-exendin-4 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pituitary uptake of Ga-68-NODAGA-exendin
Comparison of the pituitary uptake (Bq) of Ga-68-NODAGA-exendin-4 obtained by quantitative analysis
Measured: 1.5 year
Secondary outcomes (2)
Metabolic status (OGTT)
Assessment of the metabolic status by performing an OGTT (mmol/l)
Measured: 1.5 year
Metabolic status (ACTH)
Assessment of the metabolic status by performing an ACTH assay (mol/l)
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start23 May 2019
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923114
- Sponsor's protocol ID
- NL67316.091.18
- Acronym
- iPAVE
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2019
- Last updated
- 22 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPAVE - Imaging Pituitary ActiVation by Exendin
- ClinicalTrials.gov ID
- NCT03923114
- Acronym / sponsor ID
- iPAVE / NL67316.091.18
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- exendin, GLP-1 receptor agonist, HPA-axis, Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 22 Apr 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.
The main goal is the comparison of pituitary uptake of Ga-68-NODAGA-exendin-4 in patients with and without adequate response (based on HbA1c or weight loss) to GLP-1R agonist treatment.
Detailed description
The prevalence of type 2 diabetes (T2D) is increasing and a better understanding of the mechanisms of T2D becomes increasingly important. The glucagon-like peptide 1 receptor agonists (GLP-1RA), such as exendin, can be used as potent antidiabetic drugs for treatment of T2D. Not all patients with T2D respond to treatment with GLP-1RA and some even respond with contradictory effects, but the underlying mechanism for this observation remains unclear. Interestingly, uptake of an exendin-based radiotracer was observed in the pituitary gland in diabetes patients. In this study, the effect of GLP-1RA on the HPA axis will be further studied for an improved understanding of the mechanisms and contradictory treatment responses.
Patient data will be obtained and will consist of metabolic characterization (laboratory parameters and oral glucose tolerance test), an ACTH assay and determination of cortisol excretion. In addition, Ga-68-NODAGA-exendin-4 PET/CT imaging will be performed in 10 patients with treatment response (decrease in HbA1c or weight loss) and 10 patients without response after GLP-1RA therapy. In 5 patients with high radiotracer uptake, an additional brain MRI scan will be performed for improved anatomical referencing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group with treatment response | Other | Radiation: Ga-68-NODAGA-exendin-4 PET/CTPET/CT imaging of patients with response to GLP-1 receptor agonist treatment |
| Patient group without treatment response | Other | Radiation: Ga-68-NODAGA-exendin-4 PET/CTPET/CT imaging of patients with no response to GLP-1 receptor agonist treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years
- Subject is diagnosed with type 2 diabetes
- Subject showed response to GLP-1RA treatment
- Ability to sign informed consent
- Age ≥18 years
Key exclusion criteria (14 listed)
- Liver disease
- Renal disease
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- Age <18 years
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 |
|---|---|---|
| Ga-68-NODAGA-exendin-4 PET/CTPET/CT imaging after injection with Ga-68-NODAGA-exendin-4 | Radiation | Patient group with treatment response, Patient group without treatment response |
Primary outcome
Pituitary uptake of Ga-68-NODAGA-exendin
Time frame: 1.5 year
Comparison of the pituitary uptake (Bq) of Ga-68-NODAGA-exendin-4 obtained by quantitative analysis
2 secondary outcomes
Metabolic status (OGTT)
Time frame: 1.5 year
Metabolic status (ACTH)
Time frame: 1.5 year
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 22 May 2024.
- 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.
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 study testing Ga-68-NODAGA-exendin-4 PET/CT in people with Diabetes Mellitus, Type 2, run by Radboud University Medical Center at 1 site in Netherlands.
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 10 inclusion and 14 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 22 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 Netherlands. 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. 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?
Pituitary uptake of Ga-68-NODAGA-exendin (time frame: 1.5 year). 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 22 May 2024.