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

Not Applicable

Active, not recruiting

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Radiation: gallium-68-exendin injection followed by PET/CT scan

• Registration Number: NCT03917238
• Lead Sponsor: Radboud University Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-17
• Study Start: 2019-10-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-05
• Primary Completion: 2026-11-25
• Study Completion: 2026-12-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with T1D	gallium-68-exendin injection followed by PET/CT scan	gallium-68-exendin followed by a PET/CT scan (twice)

Primary Outcome Measures

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

Trial Locations

Locations (2)

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Diabeter; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands