Beta Cell Imaging During and Shortly After the Honeymoon Phase of T1D (Honeymoon)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
gallium-68-exendin injection followed by PET/CT scan
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Radboud university medical centerRecruiting
- Diabeter
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with T1D
Arm Description
gallium-68-exendin followed by a PET/CT scan (twice)
Outcomes
Primary Outcome Measures
Pancreatic uptake of gallium-68-NODAGA-exendin-4
Pancreatic uptake is measured by quantitative analysis of PET/CT scan
Secondary Outcome Measures
Full Information
NCT ID
NCT03917238
First Posted
March 13, 2019
Last Updated
October 8, 2020
Sponsor
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03917238
Brief Title
Beta Cell Imaging During and Shortly After the Honeymoon Phase of T1D
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
November 25, 2021 (Anticipated)
Study Completion Date
December 25, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with T1D
Arm Type
Other
Arm Description
gallium-68-exendin followed by a PET/CT scan (twice)
Intervention Type
Radiation
Intervention Name(s)
gallium-68-exendin injection followed by PET/CT scan
Intervention Description
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 Measure Information:
Title
Pancreatic uptake of gallium-68-NODAGA-exendin-4
Description
Pancreatic uptake is measured by quantitative analysis of PET/CT scan
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Jansen, MSc
Phone
0031243667244
Email
tom.jp.jansen@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Gotthardt, Prof. Dr.
Phone
0031243619061
Email
martin.gotthardt@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Gotthardt, Prof. Dr.
Organizational Affiliation
Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Jansen, MSc
Phone
00312467244
Email
tom.jp.jansen@radboudumc.nl
First Name & Middle Initial & Last Name & Degree
Martin Gotthardt, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Tom Jansen, MSc
Facility Name
Diabeter
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3011 TA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henk-Jan Aanstoot, Dr.
Phone
0031882807277
Email
info@diabeter.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Beta Cell Imaging During and Shortly After the Honeymoon Phase of T1D
We'll reach out to this number within 24 hrs