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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01781754
First received: January 8, 2013
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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
Diabetes
Procedure: Blood withdrawal

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

Resource links provided by NLM:


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).

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01781754

Contacts
Contact: Nachum Vaisman, MD 972-3-6974807 vaisman@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Nachum Vaisman, MD    972-3-6974807    vaisman@tasmc.health.gov.il   
Principal Investigator: Nachum Vaisman, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

Publications:
Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov 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
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mitochondrial uncoupling protein 2
Uncoupling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014