Type 1 Diabetes MellitusHoneymoonNCT03917238
Beta Cell Imaging During and Shortly After the Honeymoon Phase of T1D
A study testing gallium-68-exendin injection followed by PET/CT scan in people with Type 1 Diabetes Mellitus, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial summary
The primary goal is to correlate beta cell mass to beta cell function from measurements during and shortly after the honeymoon phase of type 1 diabetes, to improve understanding of the change in metabolic control after the honeymoon phase. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- gallium-68-exendin injection followed by PET/CT scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesNetherlands
- Study dates
- 11 Oct 2019to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years
- Diagnosed with T1D
- Presence of anti-GAD
- Subject is in honeymoon phase
- 17 ≤ BMI ≥ 30 kg/m^2 at moment of visit
- Ability to sign informed consent
Who cannot join
- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- Liver disease
- Renal disease
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- BMI <17 kg/m2 or BMI >30 kg/m2
Show all 9Show fewer
- Age <16 years
- When the end of the honeymoon phase is not observed within 11 to 13 months after the inclusion of the subject
- Inability to sign informed consent
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
Diabeter
Rotterdam, South Holland, 3011 TA
About this study
Official title: Comparison of the Beta Cell Mass During and Shortly After the Honeymoon Phase of Type 1 Diabetes Using Gallium-68-exendin PET
The primary goal is to correlate beta cell mass to beta cell function from measurements during and shortly after the honeymoon phase of type 1 diabetes, to improve understanding of the change in metabolic control after the honeymoon phase.
Read the detailed description
The exact role of beta cell mass during the development and course of diabetes is still poorly understood. Further research on beta cell mass is essential to obtain more insights that might aid in the development of diabetes treatment. This study aims at a specific phase of T1D that is called the 'honeymoon phase' or period of partial remission. Once insulin treatment has started, the honeymoon phase will arise in most patients. In this period, T1D patients become temporarily less insulin-dependent. Unfortunately, the honeymoon phase is only temporary, in which a decline in blood glucose regulation will be seen afterwards, leading to an increasing demand for insulin. To increase understanding of this change in metabolic control after the honeymoon phase, repeated measurements of the beta cell mass and function are performed during and shortly after the honeymoon phase. The comparison of both measurements might lead to an increased understanding whether changes in insulin demand after the honeymoon phase is mainly dependent on a decline in the beta cell mass, or because of a decrease in functional beta cells. The outcome of this study can provide new insights, which can contribute to the development of novel treatment options.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- gallium-68-exendin injection followed by PET/CT scan
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gallium-68-exendin injection followed by PET/CT scanRadiation
After injecting gallium-68-exendin, a PET/CT scan is performed during the honeymoon phase and repeated once the honeymoon phase has ended
| Study group | Role | What they receive |
|---|---|---|
| Patients with T1D | Other | gallium-68-exendin followed by a PET/CT scan (twice) Receives: Radiation: gallium-68-exendin injection followed by PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic uptake of gallium-68-NODAGA-exendin-4
Pancreatic uptake is measured by quantitative analysis of PET/CT scan
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start11 Oct 2019
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Gotthardt, Prof. Dr., Principal investigator, Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917238
- Sponsor's protocol ID
- NL61915.091.17
- Acronym
- Honeymoon
- Status last verified
- Jan 2024
- First submitted
- 13 Mar 2019
- Last updated
- 5 Jan 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Beta Cell Mass During and Shortly After the Honeymoon Phase of Type 1 Diabetes Using Gallium-68-exendin PET
- ClinicalTrials.gov ID
- NCT03917238
- Acronym / sponsor ID
- Honeymoon / NL61915.091.17
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 17 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 primary goal is to correlate beta cell mass to beta cell function from measurements during and shortly after the honeymoon phase of type 1 diabetes, to improve understanding of the change in metabolic control after the honeymoon phase.
Detailed description
The exact role of beta cell mass during the development and course of diabetes is still poorly understood. Further research on beta cell mass is essential to obtain more insights that might aid in the development of diabetes treatment. This study aims at a specific phase of T1D that is called the 'honeymoon phase' or period of partial remission. Once insulin treatment has started, the honeymoon phase will arise in most patients. In this period, T1D patients become temporarily less insulin-dependent. Unfortunately, the honeymoon phase is only temporary, in which a decline in blood glucose regulation will be seen afterwards, leading to an increasing demand for insulin. To increase understanding of this change in metabolic control after the honeymoon phase, repeated measurements of the beta cell mass and function are performed during and shortly after the honeymoon phase. The comparison of both measurements might lead to an increased understanding whether changes in insulin demand after the honeymoon phase is mainly dependent on a decline in the beta cell mass, or because of a decrease in functional beta cells. The outcome of this study can provide new insights, which can contribute to the development of novel treatment options.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with T1D | Other | Radiation: gallium-68-exendin injection followed by PET/CT scangallium-68-exendin followed by a PET/CT scan (twice) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 16 years
- Diagnosed with T1D
- Presence of anti-GAD
- Subject is in honeymoon phase
- 17 ≤ BMI ≥ 30 kg/m^2 at moment of visit
Key exclusion criteria (9 listed)
- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- Liver disease
- Renal disease
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
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 |
|---|---|---|
| gallium-68-exendin injection followed by PET/CT scanAfter injecting gallium-68-exendin, a PET/CT scan is performed during the honeymoon phase and repeated once the honeymoon phase has ended | Radiation | Patients with T1D |
Primary outcome
Pancreatic uptake of gallium-68-NODAGA-exendin-4
Time frame: 2 years
Pancreatic uptake is measured by quantitative analysis of PET/CT scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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.
Martin Gotthardt, Prof. Dr. principal investigator
Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gallium-68-exendin injection followed by PET/CT scan in people with Type 1 Diabetes Mellitus, run by Radboud University Medical Center at 2 sites 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 6 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Pancreatic uptake of gallium-68-NODAGA-exendin-4 (time frame: 2 years). 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 5 Jan 2024.