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临床试验/NCT03917238
NCT03917238进行中(未招募)不适用

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

Radboud University Medical Center4 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
14
试验地点
4
主要终点
Pancreatic uptake of gallium-68-NODAGA-exendin-4

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 2 years

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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