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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Radiation: gallium-68-exendin injection followed by PET/CT scan

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.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud University Medical Center
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3011 TA
      • Diabeter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with T1D; gallium-68-exendin followed by a PET/CT scan (twice)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreatic uptake of gallium-68-NODAGA-exendin-4	Pancreatic uptake is measured by quantitative analysis of PET/CT scan	2 years

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Investigators: Principal Investigator: Martin Gotthardt, Prof. Dr., Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 25, 2026

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: NL61915.091.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No