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Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01334684
Recruitment Status : Unknown
Verified February 2011 by Casa Sollievo della Sofferenza IRCCS.
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2011
Last Update Posted : April 13, 2011
Sponsor:
Collaborator:
University Hospital, Catania
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Metformin Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: White Blood Cells Gene Expression Profiles as a Tool for Predicting Metformin Efficacy in Patients With Type 2 Diabetes Mellitus
Study Start Date : May 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334684


Contacts
Contact: Salvatore De Cosmo, MD +39088241067 s.decosmo@operapadrepio.it
Contact: Ornella Ludovico, MD +390882410625 o.ludovico@operapadrepio.it

Locations
Italy
Casa Sollievo Della Sofferenza IRCCS Not yet recruiting
San Giovanni Rotondo, Foggia, Italy, 71013
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
University Hospital, Catania
Investigators
Study Chair: Salvatore De Cosmo, MD Casa Sollievo della Sofferenza IRCCS

Publications:

Responsible Party: Salvatore De Cosmo, Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier: NCT01334684     History of Changes
Other Study ID Numbers: GExpProMet
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: April 13, 2011
Last Verified: February 2011

Keywords provided by Casa Sollievo della Sofferenza IRCCS:
Type 2 Diabetes Mellitus
Metformin Efficacy
Gene Expression Profiles
Personalized Medicine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs