DiabetesDiabetesNCT01781754
Changes in Mitochondrial Uncoupling Protein 2 (UCP2) Messenger RNA(mRNA) in Type 2 Diabetes (T2DM) Patients
An observational study of Diabetes, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Blood withdrawal
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Un balanced diabetic patients
Who may be able to join
- Un balanced diabetic patients.
Who cannot join
- No current infection.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Nachum Vaisman, MD, 972-3-6974807, vaisman@tasmc.health.gov.il
Nachum Vaisman, MD
About this study
Official title: Changes in UCP2 mRNA in T2DM Patients
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.
- Conditions
- Diabetes
- Being tested
- Blood withdrawal
- Keywords
- Glycemic control, Metabolic control, Oxidative stress, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood withdrawalProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Un balanced diabetic patients Receives: Procedure: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of gene expression for UCP2 (RQ)
Checking UCP2 levels compared to HgBA1c
Measured: 6 months
Secondary outcomes (1)
Improved metabolic state
Glycemic control (glucose level and HgA1c), levels of free reactive oxygen species (ROS) and non-esterified fatty acids (NEFAs).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781754
- Sponsor's protocol ID
- TASMC-11-NV-561-CTIL
- Acronym
- Diabetes
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/j.cccn.2004.12.019. Epub 2005 Mar 17.
PubMed 15936305Rudofsky 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. doi: 10.2337/diacare.29.01.06.dc05-0757.
PubMed 16373902Dulloo AG, Samec S. Uncoupling proteins: their roles in adaptive thermogenesis and substrate metabolism reconsidered. Br J Nutr. 2001 Aug;86(2):123-39. doi: 10.1079/bjn2001412.
PubMed 11502224Schrauwen P, Hesselink M. UCP2 and UCP3 in muscle controlling body metabolism. J Exp Biol. 2002 Aug;205(Pt 15):2275-85. doi: 10.1242/jeb.205.15.2275.
PubMed 12110661Rendel M. Advances in diabetes for the millennium: nutritional therapy of type 2 diabetes. MedGenMed. 2004 Sep 1;6(3 Suppl):10.
PubMed 15647715Krauss S, Zhang CY, Lowell BB. The mitochondrial uncoupling-protein homologues. Nat Rev Mol Cell Biol. 2005 Mar;6(3):248-61. doi: 10.1038/nrm1592.
PubMed 15738989Borecky J, Vercesi AE. Plant uncoupling mitochondrial protein and alternative oxidase: energy metabolism and stress. Biosci Rep. 2005 Jun-Aug;25(3-4):271-86. doi: 10.1007/s10540-005-2889-2.
PubMed 16283557
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in UCP2 mRNA in T2DM Patients
- ClinicalTrials.gov ID
- NCT01781754
- Acronym / sponsor ID
- Diabetes / TASMC-11-NV-561-CTIL
- Conditions
- Diabetes
- Keywords
- Glycemic control, Metabolic control, Oxidative stress, Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | – | Procedure: Blood withdrawalUn balanced diabetic patients |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Un balanced diabetic patients
Key inclusion criteria (1 listed)
- Un balanced diabetic patients.
Key exclusion criteria (1 listed)
- No current infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood withdrawalThis 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). | Procedure or surgery | Diabetic patients |
Primary outcome
Levels of gene expression for UCP2 (RQ)
Time frame: 6 months
Checking UCP2 levels compared to HgBA1c
1 secondary outcome
Improved metabolic state
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
- Background: PubMed 15936305Dmitriev 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. doi: 10.1016/j.cccn.2004.12.019. Epub 2005 Mar 17.
- Background: PubMed 16373902Rudofsky 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. doi: 10.2337/diacare.29.01.06.dc05-0757.
- Background: PubMed 11502224Dulloo AG, Samec S. Uncoupling proteins: their roles in adaptive thermogenesis and substrate metabolism reconsidered. Br J Nutr. 2001 Aug;86(2):123-39. doi: 10.1079/bjn2001412.
- Background: PubMed 12110661Schrauwen P, Hesselink M. UCP2 and UCP3 in muscle controlling body metabolism. J Exp Biol. 2002 Aug;205(Pt 15):2275-85. doi: 10.1242/jeb.205.15.2275.
- Background: PubMed 15647715Rendel M. Advances in diabetes for the millennium: nutritional therapy of type 2 diabetes. MedGenMed. 2004 Sep 1;6(3 Suppl):10.
- Background: PubMed 15738989Krauss S, Zhang CY, Lowell BB. The mitochondrial uncoupling-protein homologues. Nat Rev Mol Cell Biol. 2005 Mar;6(3):248-61. doi: 10.1038/nrm1592.
- Background: PubMed 16283557Borecky J, Vercesi AE. Plant uncoupling mitochondrial protein and alternative oxidase: energy metabolism and stress. Biosci Rep. 2005 Jun-Aug;25(3-4):271-86. doi: 10.1007/s10540-005-2889-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, MD (972-3-6974807, vaisman@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of gene expression for UCP2 (RQ) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781754, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013; AzTrials last refreshed its copy on 4 Nov 2026.