Clinical trial NCT01334684: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes Mellitus
Metformin Efficacy
Gene Expression Profiles
Personalized Medicine
Lead sponsor: Casa Sollievo della Sofferenza IRCCS
Sponsor class: OTHER
Collaborators: name: University Hospital, Catania
First posted: 2011-04-13
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Fasting glucose change after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells
timeFrame: Baseline and after three months of metfomin therapy
Secondary outcomes:
measure: Change in fasting insulin levels after metformin treatment in respect to mRNA and miRNA expression profiles in white blood cells
timeFrame: Baseline and after three months of metfomin therapy
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: Casa Sollievo Della Sofferenza IRCCS
state: Foggia
Study officials:
affiliation: Casa Sollievo della Sofferenza IRCCS
name: Salvatore De Cosmo, MD
role: STUDY_CHAIR
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