The comparison of the number of insulin-producing cells during and shortly after the honeymoon phase of type 1 diabetes

Phase 1

• Conditions: Type 1 diabetes; MedDRA version: 20.0Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2017-002959-29-NL
• Lead Sponsor: Radboud university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-13
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

-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
-Ability to sign informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 18
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous treatment (within 6 months) with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase lV
inhibitors
- Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of the normal range
- Renal disease defined as MDRD <40 ml/min/1.73 m^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
- lnability to sign informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine possible differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.;Secondary Objective: The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase.;Primary end point(s): The primary study objective is to determine the beta cell mass in subjects with type 1 diabetes during and shortly after the honeymoon phase, to examine the differences in beta cell mass and to improve understanding of the change in metabolic control after the honeymoon phase.;Timepoint(s) of evaluation of this end point: 1 hour after the administration of the tracer (for both scans)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary aim is to correlate the beta cell mass to the beta cell function from the measurements that will be performed during and shortly after the honeymoon phase.;Timepoint(s) of evaluation of this end point: After the analysis of the mixed-meal tolerance tests and PET/CT scans