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

January 4, 2024 updated by: Radboud University Medical Center

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 years
Pancreatic uptake is measured by quantitative analysis of PET/CT scan
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Martin Gotthardt, Prof. Dr., Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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