Comparison of the beta cell mass during and shortly after the honeymoon phase of type 1 diabetes using Ga-68-exendin PET
- Conditions
- Diabetes mellitus type 1diabetes type 110018424
- Registration Number
- NL-OMON47470
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
honeymoon phase
- Age >=16 years
- Subject is diagnosed with type 1 diabetes (T1D)
- Presence of anti-GAD (glutamic acid decarboxylase)
- Subject is in the honeymoon phase of T1D: IDAA1c <9
- 17<= BMI <=30 kg/m^2 at the moment of the first visit
- Ability to sign informed consent
- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors
- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than 3 times the upper limit of normal range
- Renal disease defined as MDRD <40 ml/min/1.73m^2
- Pregnancy or the wish to become pregnant within 6 months after the study
- Breastfeeding
- BMI <17 kg/m^2 or BMI >30 kg/m^2
- Age <16 years
- When the end of the honeymoon phase (IDAA1c >=9) is not observed within 11 to 13 months after the inclusion of the subject
- Inability to sign informed consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study objective is to determine the beta cell mass in subjects with<br /><br>type 1 diabetes during and shortly after the honeymoon phase, to examine<br /><br>possible differences in beta cell mass and to improve understanding of the<br /><br>change in metabolic control after the honeymoon phase.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary aim is to correlate the beta cell mass to the beta cell function<br /><br>from the measurements that will be performed during and shortly after the<br /><br>honeymoon phase.</p><br>