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

NCT ID: NCT01349387

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-01-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume CHARPENTIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHSF-CERITD

Locations

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Countries

France

Other Identifiers

2011-000128-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2010-A01389-30

Identifier Type: -

Identifier Source: org_study_id