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临床试验/NCT02967354
NCT02967354已完成不适用

[11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 Diabetes

Per-Ola Carlsson0 个研究点目标入组 39 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
39
主要终点
[11C]5-hydroxy-tryptophan Uptake in the Pancreas

研究概览

简要总结

Cross-sectional study to investigate subjects at different stages of type 2 diabetes development with expected stratification of pancreatic islet mass. Non-diabetic individuals were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and retention in the pancreas as a surrogate marker for the endogenous islet mass.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes fulfilling criteria for the four different study groups, or healthy volunteers

排除标准

  • Ongoing pregnancy
  • Renal failure (GFR<60 ml/min)
  • Magnetic metal parts in the body
  • Ongoing treatment with selective serotonin receptor inhibitors

研究组 & 干预措施

Healthy control

Experimental

Healthy control

干预措施: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan (Radiation)

Obese with oral antidiabetic drugs

Experimental

BMI>30, Type 2 diabetes treated with oral antidiabetic drugs

干预措施: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan (Radiation)

Obese, treated with oral antidiabetic drugs + insulin

Experimental

BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin

干预措施: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan (Radiation)

Normal weight, treated with oral antidiabetic drugs

Experimental

BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs

干预措施: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan (Radiation)

Normal weight, treated with oral antidiabetic drugs + insulin

Experimental

BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin

干预措施: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan (Radiation)

结局指标

主要结局

[11C]5-hydroxy-tryptophan Uptake in the Pancreas

时间窗: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release

Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release

次要结局

  • Pancreatic Volume(Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release)
  • Pancreatic Fat Content(Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release)
  • Hepatic Fat Content(Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release)
  • Pancreatic Perfusion(Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Per-Ola Carlsson

Professor, Senior consultant

Uppsala University Hospital

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