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

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03917238
• Collaborator: (none)
• Enrollment: 14
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 26.5
• Patients Per Site: 7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Radiation: gallium-68-exendin injection followed by PET/CT scan	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Oct 11, 2019
• Anticipated Primary Completion Date: Nov 25, 2021
• Anticipated Study Completion Date: Dec 25, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pancreatic uptake of gallium-68-NODAGA-exendin-4 [2 years]

   Pancreatic uptake is measured by quantitative analysis of PET/CT scan

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud university medical center	Nijmegen	Gelderland	Netherlands	6525 GA
2	Diabeter	Rotterdam	Zuid-Holland	Netherlands	3011 TA

Sponsors and Collaborators

• Radboud University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT03917238
• Other Study ID Numbers: NL61915.091.17
• First Posted: Apr 17, 2019
• Last Update Posted: Oct 9, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Oct 9, 2020