Changes in Mitochondrial Uncoupling Protein 2 (UCP2) Messenger RNA(mRNA) in Type 2 Diabetes (T2DM) Patients (Diabetes)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781754
Recruitment Status : Unknown
Verified January 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : February 1, 2013
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Brief Summary:

Many patients with Diabetes find difficulties in achieving glycemic control. Hemoglobin A1c(HgBA1c) is used as a marker for glycemic control. UCP2 is affected by high glucose levels, high free fatty acids and high oxidative stress.

The investigators intend to learn about the changes in UCP2 along the process of reaching glycemic control.

Condition or disease Intervention/treatment
Diabetes Procedure: Blood withdrawal

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in UCP2 mRNA in T2DM Patients
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Diabetic patients
Un balanced diabetic patients
Procedure: Blood withdrawal
This is the only intervention that is part of the study. A family physician or other physician will be responsible of the diabetic treatment (common treatment, e.g Metformin).

Primary Outcome Measures :
  1. Levels of gene expression for UCP2 (RQ) [ Time Frame: 6 months ]
    Checking UCP2 levels compared to HgBA1c

Secondary Outcome Measures :
  1. Improved metabolic state [ Time Frame: 6 months ]
    Glycemic control (glucose level and HgA1c), levels of free reactive oxygen species (ROS) and non-esterified fatty acids (NEFAs).

Biospecimen Retention:   Samples Without DNA
Whole blood for UCP2 mRNA

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Un balanced diabetic patients

Inclusion Criteria:

  • Un balanced diabetic patients.

Exclusion Criteria:

  • No current infection.

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 identifier (NCT number): NCT01781754

Contact: Nachum Vaisman, MD 972-3-6974807

Tel Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Nachum Vaisman, MD    972-3-6974807   
Principal Investigator: Nachum Vaisman, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01781754     History of Changes
Other Study ID Numbers: TASMC-11-NV-561-CTIL
First Posted: February 1, 2013    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Tel-Aviv Sourasky Medical Center:
Glycemic control
Metabolic control
Oxidative stress