Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

April 12, 2011 updated by: Casa Sollievo della Sofferenza IRCCS

White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Foggia
      • San Giovanni Rotondo, Foggia, Italy, 71013
        • Casa Sollievo Della Sofferenza IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Drug: Metformin
Metformin, pills, 850 mg three times a day for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after three months of metfomin therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and after three months of metfomin therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa Sollievo della Sofferenza IRCCS

Collaborators

University Hospital, Catania

Investigators

  • Study Chair: Salvatore De Cosmo, MD, Casa Sollievo Della Sofferenza IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

April 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 12, 2011

First Posted (ESTIMATE)

April 13, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 13, 2011

Last Update Submitted That Met QC Criteria

April 12, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GExpProMet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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