Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes Mellitus, Metformin Efficacy, Gene Expression Profiles, Personalized Medicine
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.
Interventions
DRUGMetformin
Metformin, pills, 850 mg three times a day for three months
Sponsors
University Hospital, Catania
Casa Sollievo della Sofferenza IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactSalvatore De Cosmo, MD
Backup ContactOrnella Ludovico, MD
Outcome results
None listed