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

Type 1 Diabetes Mellitus Clinical Trial

— Honeymoon  

Official title:

Comparison of the Beta Cell Mass During and Shortly After the Honeymoon Phase of Type 1 Diabetes Using Gallium-68-exendin PET

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03917238
• Other study ID #: NL61915.091.17
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 11, 2019
• Est. completion date: December 25, 2026

Study information

• Verified date: January 2024
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: December 25, 2026
• Est. primary completion date: November 25, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland
Netherlands	Diabeter	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic uptake of gallium-68-NODAGA-exendin-4	Pancreatic uptake is measured by quantitative analysis of PET/CT scan	2 years