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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03917238
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : October 9, 2020
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Radiation: gallium-68-exendin injection followed by PET/CT scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of the Beta Cell Mass During and Shortly After the Honeymoon Phase of Type 1 Diabetes Using Gallium-68-exendin PET
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : November 25, 2021
Estimated Study Completion Date : December 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pancreatic uptake of gallium-68-NODAGA-exendin-4 [ Time Frame: 2 years ]
    Pancreatic uptake is measured by quantitative analysis of PET/CT scan

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03917238

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Contact: Tom Jansen, MSc 0031243667244
Contact: Martin Gotthardt, Prof. Dr. 0031243619061

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Radboud university medical center Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GA
Contact: Tom Jansen, MSc    00312467244   
Principal Investigator: Martin Gotthardt, Prof. Dr.         
Sub-Investigator: Tom Jansen, MSc         
Diabeter Not yet recruiting
Rotterdam, Zuid-Holland, Netherlands, 3011 TA
Contact: Henk-Jan Aanstoot, Dr.    0031882807277   
Sponsors and Collaborators
Radboud University
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Principal Investigator: Martin Gotthardt, Prof. Dr. Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands
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Responsible Party: Radboud University Identifier: NCT03917238    
Other Study ID Numbers: NL61915.091.17
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases