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Clinical Trials/NCT01349387
NCT01349387
Completed
Not Applicable

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 site in 1 country25 target enrollmentMay 2011
ConditionsType 2 Diabetes
InterventionsMetformin

Overview

Phase
Not Applicable
Intervention
Metformin
Conditions
Type 2 Diabetes
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Enrollment
25
Locations
1
Primary Endpoint
Comparison of expression of isoforms A and B of the insulin receptor using quantitative RT PCR
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
January 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

Arm1

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.

Intervention: Metformin

Outcomes

Primary Outcomes

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

Time Frame: 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)

Study Sites (1)

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