Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Drug: Metformin

• Registration Number: NCT01334684
• Lead Sponsor: Casa Sollievo della Sofferenza IRCCS

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2011-02
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-12
• Last Update Submitted: 2011-04-12
• Study First Posted: 2011-04-13
• Last Update Posted: 2011-04-13
• Study Start: 2011-05
• Primary Completion: 2013-04
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Type 2 diabetes (duration of diabetes of at least 2 years)
• age 40-70 yrs
• HbA1c > 6.4 < 9.0

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Exclusion Criteria

• insulin therapy
• contraindications to metformin use

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Casa Sollievo Della Sofferenza IRCCS; 🇮🇹 San Giovanni Rotondo, Foggia, Italy