Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA) expression profiles in white blood cells, predict metformin monotherapy efficacy in patients with type 2 diabetes. |
|---|---|
| Condition | Type 2 Diabetes |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Casa Sollievo della Sofferenza IRCCS |
| Responsible Party | Casa Sollievo della Sofferenza IRCCS |
| ClinicalTrials.gov Identifier | NCT01334684 |
| First Received | April 12, 2011 |
| Last Updated | April 12, 2011 |
| Last verified | February 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 12, 2011 |
|---|---|
| Last Updated Date | April 12, 2011 |
| Start Date | May 2011 |
| Estimated Primary Completion Date | September 2013 |
| Current Primary Outcome Measures | Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells [Time Frame: Baseline and after three months of metfomin therapy] [Designated as safety issue: Yes]Changes in fasting glucose levels will be used to evaluate if metformin monotherapy efficacy in type 2 diabetic patients is predicted by mRNA and/or miRNA expression profiles. Please note that metformin major effect is to decrease hepatic glucose output and, therefore, to lower fasting plasma glucose which is, in fact, the clinical outcome used in this study. Finally, because of a very short wash-out period (i.e. 5 days) we will not be able to use HbA1c which will be inevitably conditioned by previous oral hypoglicemic therapy. |
| Current Secondary Outcome Measures | Change in fasting insulin levels after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells [Time Frame: Baseline and after three months of metfomin therapy] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes |
|---|---|
| Official Title | White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus |
| Brief Summary | Our general aim is to investigate whether messenger RNA (mRNA) and/or microRNA (miRNA) expression profiles in white blood cells, predict metformin monotherapy efficacy in patients with type 2 diabetes. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Type 2 Diabetes |
| Intervention | Drug: Metformin Metformin, pills, 850 mg three times a day for three months |
| Study Arm (s) | Other: Metformin At study entry, all oral hypoglycemic agents will be discontinued for 5 days and then metformin (2,550 mg/daily) will be given for 3 months. Fasting plasma glucose will be measured at baseline and 3 months after metformin treatment. Patients will be stratified according to the median value of metformin efficacy as indicated by fasting glucose change after metformin treatment (i.e. baseline fasting glucose minus 3-month fasting glucose). So, two subgroups of patients will be obtained, defined as relatively "high responders" (individual fasting glucose change > median value) or relatively "low responders" (individual fasting glucose change < median value) to metformin monotherapy. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 100 |
| Estimated Completion Date | September 2013 |
| Estimated Primary Completion Date | April 2013 |
| Eligibility Criteria | Inclusion Criteria: - Type 2 diabetes (duration of diabetes of at least 2 years) - age 40-70 yrs - HbA1c > 6.4 < 9.0 Exclusion Criteria: - insulin therapy - contraindications to metformin use |
| Gender | Both |
| Ages | 40 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Salvatore De Cosmo, MD +39088241067 s.decosmo@operapadrepio.it |
| Location Countries | Italy |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01334684 |
|---|---|
| Other Study ID Numbers | GExpProMet |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Casa Sollievo della Sofferenza IRCCS |
| Study Sponsor | Casa Sollievo della Sofferenza IRCCS |
| Collaborators | University Hospital, Catania |
| Investigators | Study Chair: Salvatore De Cosmo, MD Casa Sollievo della Sofferenza IRCCS |
| Verification Date | February 2011 |
Locations[ + expand ][ + ]
| Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo, Foggia, Italy, 71013 Not yet recruiting |
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