Type 1 Diabetes Mellitus
Conditions
Brief 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.
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.
Interventions
RADIATIONgallium-68-exendin injection followed by PET/CT scan
After injecting gallium-68-exendin, a PET/CT scan is performed during the honeymoon phase and repeated once the honeymoon phase has ended
Sponsors
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic uptake of gallium-68-NODAGA-exendin-4 | 2 years | Pancreatic uptake is measured by quantitative analysis of PET/CT scan |
Countries
Netherlands
Outcome results
None listed