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NCT Number: NCT03917238

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gallium-68-exendin injection followed by PET/CT scan

Radiation

After injecting gallium-68-exendin, a PET/CT scan is performed during the honeymoon phase and repeated once the honeymoon phase has ended

Primary outcomes

  1. Pancreatic uptake of gallium-68-NODAGA-exendin-4

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Acronym: Honeymoon

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2019
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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