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Clinical Trials in the Netherlands / NCT03917238
Active, not recruiting Not applicable

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

NCT03917238 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Radboud University Medical Center
Phase
Not applicable
Started
2019-10-11
Last updated
2024-01-05

Condition(s) studied

Type 1 Diabetes Mellitus

Investigational drug(s) / intervention(s)

gallium-68-exendin injection followed by PET/CT scan

gallium-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

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
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

Primary outcome measure(s)

  • Pancreatic uptake of gallium-68-NODAGA-exendin-4 — 2 years
    Pancreatic uptake is measured by quantitative analysis of PET/CT scan

Trial sites (2)

FacilityCityRegionStatus
Radboud university medical center Nijmegen Gelderland
Diabeter Rotterdam South Holland

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Other trials for the same condition

A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes Recruiting
Effect of Inulin Supplementation on Glycaemic Control and Immunological Parameters in Type 1 Diabetes (2024) Recruiting
Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03917238 on ClinicalTrials.gov ↗ ← All trials in the Netherlands