Beta Cell Imaging During and Shortly After the Honeymoon Phase of T1D

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Beta Cell Mass During and Shortly After the Honeymoon Phase of Type 1 Diabetes Using Gallium-68-exendin PET

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Radiation: gallium-68-exendin injection followed by PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with T1D<br>gallium-68-exendin followed by a PET/CT scan (twice) | Radiation: gallium-68-exendin injection followed by PET/CT scan<br>* After injecting gallium-68-exendin, a PET/CT scan is performed during the honeymoon phase and repeated once the honeymoon phase has ended<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic uptake of gallium-68-NODAGA-exendin-4 | Pancreatic uptake is measured by quantitative analysis of PET/CT scan | 2 years |