跳至主要内容
临床试验/NCT01349374
NCT01349374终止不适用

Study Aiming to Collect Skin Samples of Diabetic Patients and Healthy Volunteers for Cellular Reprogramming, Within the Framework of New Therapeutic Strategies in Diabetes Treatment

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
80
试验地点
2
主要终点
Nothing will be measured, the aim of the study is the obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines.

研究概览

简要总结

The main objective of this study is the Obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

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

入选标准

  • Diabetic patients diagnosed for type 2 diabetes, with a BMI between 20 and 25, without familial history and known genetic cause of diabetes.
  • Diabetic patients diagnosed for MODY diabetes (1, 2, 3, 4, 5 or 6), with a BMI between 20 and
  • Healthy volunteers, siblings of MODY patients (1, 2, 3, 4, 5 or 6).
  • Healthy volunteers without familial history of diabetes.
  • Patients over 18 years old.
  • Patients with social insurance coverage
  • Patients who signed a consent form

排除标准

  • Type 1 diabetic patients.
  • Pregnant women or women who might get pregnant

结局指标

主要结局

Nothing will be measured, the aim of the study is the obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines.

时间窗: patients will be followed for the duration of hospital stay, an expected average of 2 hours.

* Each patient will have a consultation at the hospital. During this consultation, if the patient agrees to participate in the study, the doctor will make him/her sign a consent form and an appointment will be scheduled with the dermatologist for the skin biopsy. * The dermatologist will perform the skin biopsy, the sample will then be carried to the Evry genopole, where the derivation of dermal fibroblasts will be done, and the cells will then be sent to iPierian center, in California, which will take care of the obtention of cell lines.

次要结局

未报告次要终点

研究者

发起方
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
申办方类型
Other
责任方
Sponsor

研究点 (2)

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