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临床试验/NCT01349387
NCT01349387已完成不适用

Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing Whose Maturation Depends on the Protein HuR, Including Gene Encoding Insulin Receptor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
1
主要终点
Comparison of expression of isoforms A and B of the insulin receptor using quantitative RT PCR

研究概览

简要总结

Main objective : Show that treatment with metformin in patients with type 2 diabetes has an effect on alternative splicing of the insulin receptor.

Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with discontinuation of treatment with metformin can be réversé by the resumption of metformin treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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

  • Type 2 Diabetic patients usually treated with metformin (≥ 1400 mg/day), associated or not to other oral anti-diabetic treatment or. injection treatment
  • Patients major.
  • Patients with a social security number
  • Patients having signed a consent to participate in the study

排除标准

  • Intolerance metformin
  • Patients with type
  • Patients on pioglitazone or rosiglitazone
  • Renal failure by an anomaly of the creatinine clearance (< 60 mL/min).
  • Patients pregnant or likely to be.

研究组 & 干预措施

Arm1

Experimental

During their visit of consultation on the follow-up to the type 2 diabetes, les patients will be selected on the basis of active metformin treatment at a dose greater than or equal to 1400 mg/day. Patients will have to achieve a 10 ml blood sample. The blood will be processed by Ficoll gradient centrifugation to remove the red cells and isolate circulating leukocytes: this stage will be conducted in the CERITD. Analysis on circulating leukocytes and in particular the quantification of expressions of isoforms A and B of the INSR1 by quantitative RT - PCR gene will be conducted in the laboratory of the Professor Marc Peschanski (unit INSERM 861 I - STEM of Evry).

After inclusion in the study to J0, metformin treatment will be interrupted between J1 and J30, replaced by Januvia 100 mg/day dose, then resumed at J31.

干预措施: Metformin (Drug)

结局指标

主要结局

Comparison of expression of isoforms A and B of the insulin receptor using quantitative RT PCR

时间窗: inclusion (baseline), 30th days and 60th days

comparison of the A isoform (without inclusion of exon 11) and B isoform (with inclusion of exon 11) ratio of the receptor in insulin, during the first period (without metformin) and the second period (with metformin)

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 (1)

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