search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Metformin
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Sud Francilien

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm1

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 3, 2011
Last Updated
February 8, 2012
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
search

1. Study Identification

Unique Protocol Identification Number
NCT01349387
Brief Title
Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing
Acronym
METFORGENE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm1
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of expression of isoforms A and B of the insulin receptor using quantitative RT PCR
Description
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)
Time Frame
inclusion (baseline), 30th days and 60th days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 1. Patients on pioglitazone or rosiglitazone Renal failure by an anomaly of the creatinine clearance (< 60 mL/min). Patients pregnant or likely to be.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume CHARPENTIER, MD
Organizational Affiliation
CHSF-CERITD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs