Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing (METFORGENE)

February 8, 2012 updated by: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil Essonnes, France, 91106
        • Centre hospitalier Sud Francilien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 1.
  • Patients on pioglitazone or rosiglitazone
  • Renal failure by an anomaly of the creatinine clearance (< 60 mL/min).
  • Patients pregnant or likely to be.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Metformin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
inclusion (baseline), 30th days and 60th days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Guillaume CHARPENTIER, MD, CHSF-CERITD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 5, 2011

First Posted (ESTIMATE)

May 6, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-A01389-30
  • 2011-000128-13 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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