Evaluation of the Use of 11C-5-HTP PET to Calculate βCell Mass in Clinical Islet Transplantation (DAIT CIT-09)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- The relationship between β cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes
研究概览
简要总结
In people with type I diabetes, the insulin producing cells in the pancreas have been destroyed. Presently one can only evaluate the function of the graft through laboratory tests, blood sugars and the insulin requirements. The mass of the insulin producing cells and their location are not known. The possibility to study the mass of insulin producing cells is of importance when developing new treatment regimes, in order to evaluate their efficacy on this parameter.
The researchers in this study are aiming to develop methods to measure the mass of insulin producing cells. A method (positron emission tomography, PET) previously used for the diagnosis of tumors of insulin producing cells may also be used to measure the amount of insulin producing cells in patients with type I diabetes. They plan to evaluate participants with type 1 diabetes that have undergone islet transplantation, to evaluate if PET can be used to measure the beta cell mass after islet transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be considered eligible for participation in the study:
- •Subjects who are able to provide written informed consent and comply with the procedures of the study protocol.
- •Patient that has received an islet transplant in or outside the CIT01 trial (post primary endpoint).
排除标准
- •Subjects who meet any of these criteria are not eligible for participation in the study:
- •For female subjects: Positive serum pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures at the time of PET scan +/- 2 weeks.
- •Known history of severe co-existing cardiac disease, characterized by any one of the following conditions:
- •Recent myocardial infarction (within past 6 months).
- •Evidence of ischemia on functional cardiac exam within the last year.
- •Left ventricular ejection fraction <30%.
- •Persistent elevation of liver function tests at the time of study entry. Persistent Aspartate Aminotransferase (serum glutamic-oxaloacetic transaminase), Alanine Aminotransferase (serum glutamate pyruvate transaminase), Alkaline phosphatase or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
- •Treatment with any anti-diabetic medication, other than insulin, within 4 weeks of enrollment.
- •Use of any investigational agents within 4 weeks of enrollment.
- •Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
结局指标
主要结局
The relationship between β cell mass calculated from the 11C-5-HTP PET scans and the MMTT C-peptide at 90 minutes
时间窗: 8 month
Regression methods will be used to describe the association between the beta cell mass and 90 minute c-peptide.
次要结局
- The relationship between βcell mass calculated from the 11C-5-HTP PET and the β-score computed at the time of the PET scan(8 month)
- The relationship between βcell mass calculated from the 11C-5-HTP PET and CPGCR computed at the time of the PET scan(8 month)
- The relationship with PET and peak C-peptide(8 month)
- The distribution of islets in the liver related to distribution of fat accumulation in the liver as measured by MRI(8 month)
- The relationship between βcell mass calculated from the 11C-5-HTP PET and number of islets transplanted (Total IEQ)(8 month)
- The relationship between distribution patterns in the liver and MMTT C-peptide at 90 minutes computed at the time of the PET scan(8 month)
- The incidence and severity of adverse events related to the PET investigation including allergic reactions(8 month)
- The distribution of islets in the liver(8 month)
- The distribution of fat accumulation in the liver(8 month)
- The relationship with PET and C-peptide AUC(8 month)