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Gene Expression Profiles and Metformin Efficacy in Type 2 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Casa Sollievo della Sofferenza IRCCS.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University Hospital, Catania
Information provided by:
Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier:
NCT01334684
First received: April 12, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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 Intervention
Type 2 Diabetes
Drug: Metformin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Casa Sollievo della Sofferenza IRCCS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Salvatore De Cosmo, Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier: NCT01334684     History of Changes
Other Study ID Numbers: GExpProMet
Study First Received: April 12, 2011
Last Updated: April 12, 2011
Health Authority: Italy: Ethics Committee

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014