NCT01781767

Brief Summary

This study objective is to evaluate the change in mitochondrial uncoupling protein 2 (UCP2) mRNA expression as function of thyroid activity (TSH, T3 and Free T4).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

1.5 years

First QC Date

January 27, 2013

Last Update Submit

January 30, 2013

Conditions

Thyroid Cancer

Keywords

UCP2Thyroid functionThyroid carcinoma

Outcome Measures

Primary Outcomes (1)

  • Changes in UCP2 mRNA concentrations.

    The difference between the result at two weeks and four months compare to base line.

    Base line (before opporation), 2 weeks after opporation and for after opporation.

Secondary Outcomes (2)

  • Weight

    Approximately 4 months

  • Resting energy expenditure

    Approximatly 4 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were diagnosed with thyroid carcinoma and are going throgh total thyroidectomy and recive a thyroid replacement therapy.

You may qualify if:

  • Patients who were diagnosed with thyroid carcinoma and are going to have total thyroidectomy.
  • Patients with unbalanced thyroid hormones.
  • Aged 18-65 years at the time of screening.
  • Provision of written informed consent.

You may not qualify if:

  • Patients with Diabetes.
  • Patients with any other chronic inflammatory diseases.
  • Steroid treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (5)

  • Yen PM. Physiological and molecular basis of thyroid hormone action. Physiol Rev. 2001 Jul;81(3):1097-142. doi: 10.1152/physrev.2001.81.3.1097.

    PMID: 11427693BACKGROUND

  • Schwartz HL, Oppenheimer JH. Physiologic and biochemical actions of thyroid hormone. Pharmacol Ther B. 1978;3(3):349-76. doi: 10.1016/s0306-039x(78)80002-6. No abstract available.

    PMID: 203955BACKGROUND

  • Brand MD, Esteves TC. Physiological functions of the mitochondrial uncoupling proteins UCP2 and UCP3. Cell Metab. 2005 Aug;2(2):85-93. doi: 10.1016/j.cmet.2005.06.002.

    PMID: 16098826BACKGROUND

  • Nicholls DG, Locke RM. Thermogenic mechanisms in brown fat. Physiol Rev. 1984 Jan;64(1):1-64. doi: 10.1152/physrev.1984.64.1.1. No abstract available.

    PMID: 6320232BACKGROUND

  • Gjedde S, Gormsen LC, Riis AL, Jorgensen JO, Rungby J, Moller N, Weeke J, Pedersen SB. Reduced expression of uncoupling protein 2 in adipose tissue in patients with hypothyroidism. J Clin Endocrinol Metab. 2010 Jul;95(7):3537-41. doi: 10.1210/jc.2009-0907. Epub 2010 Apr 28.

    PMID: 20427509BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood for UCP2 mRNA

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Nachum Vaisman, M.D.

CONTACT

972-3-6974807vaisman@tasmc.health.gov.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2013

First Posted

February 1, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

IL(1)