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

Diabetes Clinical Trial

— Diabetes  

Official title:

Changes in UCP2 mRNA in T2DM Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01781754
• Other study ID #: TASMC-11-NV-561-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2013
• Last updated: January 30, 2013
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, MD
• Phone: 972-3-6974807
• Email: vaisman[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Un balanced diabetic patients.

Exclusion Criteria:

• No current infection.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Intervention

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).

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (7)

Borecký J, Vercesi AE. Plant uncoupling mitochondrial protein and alternative oxidase: energy metabolism and stress. Biosci Rep. 2005 Jun-Aug;25(3-4):271-86. Review. — View Citation

Dmitriev AD, Factor MI, Segal OL, Pavlova EV, Massino YS, Smirnova MB, Yakovleva DA, Dmitriev DA, Kizim EA, Kolyaskina GI, Brusov OS. Western blot analysis of human and rat serotonin transporter in platelets and brain using site-specific antibodies: evidence that transporter undergoes endoproteolytic cleavage. Clin Chim Acta. 2005 Jun;356(1-2):76-94. Epub 2005 Mar 17. — View Citation

Dulloo AG, Samec S. Uncoupling proteins: their roles in adaptive thermogenesis and substrate metabolism reconsidered. Br J Nutr. 2001 Aug;86(2):123-39. Review. — View Citation

Krauss S, Zhang CY, Lowell BB. The mitochondrial uncoupling-protein homologues. Nat Rev Mol Cell Biol. 2005 Mar;6(3):248-61. Review. — View Citation

Rendel M. Advances in diabetes for the millennium: nutritional therapy of type 2 diabetes. MedGenMed. 2004 Sep 1;6(3 Suppl):10. Review. — View Citation

Rudofsky G Jr, Schroedter A, Schlotterer A, Voron'ko OE, Schlimme M, Tafel J, Isermann BH, Humpert PM, Morcos M, Bierhaus A, Nawroth PP, Hamann A. Functional polymorphisms of UCP2 and UCP3 are associated with a reduced prevalence of diabetic neuropathy in patients with type 1 diabetes. Diabetes Care. 2006 Jan;29(1):89-94. — View Citation

Schrauwen P, Hesselink M. UCP2 and UCP3 in muscle controlling body metabolism. J Exp Biol. 2002 Aug;205(Pt 15):2275-85. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of gene expression for UCP2 (RQ)	Checking UCP2 levels compared to HgBA1c	6 months	No
Secondary	Improved metabolic state	Glycemic control (glucose level and HgA1c), levels of free reactive oxygen species (ROS) and non-esterified fatty acids (NEFAs).	6 months	No