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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center Identifier:
First received: January 8, 2013
Last updated: January 30, 2013
Last verified: January 2013

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 Intervention
Procedure: Blood withdrawal

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in UCP2 mRNA in T2DM Patients

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Levels of gene expression for UCP2 (RQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Checking UCP2 levels compared to HgBA1c

Secondary Outcome Measures:
  • Improved metabolic state [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).


Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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.
  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 identifier: 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
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01781754     History of Changes
Other Study ID Numbers: TASMC-11-NV-561-CTIL 
Study First Received: January 8, 2013
Last Updated: January 30, 2013
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Mitochondrial uncoupling protein 2
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Uncoupling Agents processed this record on May 24, 2016