Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT01334684|
Recruitment Status : Unknown
Verified February 2011 by Casa Sollievo della Sofferenza IRCCS.
Recruitment status was: Not yet recruiting
First Posted : April 13, 2011
Last Update Posted : April 13, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: Metformin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||April 2013|
|Estimated Study Completion Date :||September 2013|
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
- 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 ]
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334684
|Contact: Salvatore De Cosmo, MDfirstname.lastname@example.org|
|Contact: Ornella Ludovico, MDemail@example.com|
|Casa Sollievo Della Sofferenza IRCCS||Not yet recruiting|
|San Giovanni Rotondo, Foggia, Italy, 71013|
|Study Chair:||Salvatore De Cosmo, MD||Casa Sollievo della Sofferenza IRCCS|