Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes
Recruitment status was: Not yet recruiting
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus|
- 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.
- 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 ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
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.
Metformin, pills, 850 mg three times a day for three months
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334684
|Casa Sollievo Della Sofferenza IRCCS|
|San Giovanni Rotondo, Foggia, Italy, 71013|
|Study Chair:||Salvatore De Cosmo, MD||Casa Sollievo della Sofferenza IRCCS|