Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Type 2 Diabetes |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète |
| Responsible Party | Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète |
| ClinicalTrials.gov Identifier | NCT01349387 |
| First Received | May 3, 2011 |
| Last Updated | February 8, 2012 |
| Last verified | May 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 3, 2011 |
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| Last Updated Date | February 8, 2012 |
| Start Date | May 2011 |
| Estimated Primary Completion Date | January 2012 |
| Current Primary Outcome Measures | 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] [Designated as safety issue: No]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) |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing |
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| 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 |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science |
| Condition | Type 2 Diabetes |
| Intervention | 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. |
| Study Arm (s) | 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. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 25 |
| Estimated Completion Date | January 2012 |
| Estimated Primary Completion Date | November 2011 |
| 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | France |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01349387 |
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| Other Study ID Numbers | 2010-A01389-30 |
| Has Data Monitoring Committee | No |
| Information Provided By | Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète |
| Study Sponsor | Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Guillaume CHARPENTIER, MD CHSF-CERITD |
| Verification Date | May 2011 |
Locations[ + expand ][ + ]
| Centre Hospitalier Sud Francilien | Corbeil Essonnes, France, 91106 |
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