White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Metformin
- Conditions
- Type 2 Diabetes
- Sponsor
- Casa Sollievo della Sofferenza IRCCS
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: Metformin
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in fasting insulin levels after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells(Baseline and after three months of metfomin therapy)