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Changes in Metabolic Status in Patients With Total Thyroidectomy (Thyroid cancer)

This study is currently recruiting participants.
Verified January 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01781767
First received: January 27, 2013
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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).


Condition
Thyroid Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Changes in UCP2 mRNA concentrations. [ Time Frame: Base line (before opporation), 2 weeks after opporation and for after opporation. ] [ Designated as safety issue: No ]
    The difference between the result at two weeks and four months compare to base line.


Secondary Outcome Measures:
  • Weight [ Time Frame: Approximately 4 months ] [ Designated as safety issue: No ]
  • Resting energy expenditure [ Time Frame: Approximatly 4 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood for UCP2 mRNA


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Blood will be drown before thyroidectomy, 2 weeks after the operation and 3-4 month after the operation.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with Diabetes.
  • Patients with any other chronic inflammatory diseases.
  • Steroid treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781767

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

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

Publications:

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01781767     History of Changes
Other Study ID Numbers: TASMC-12-NV-376-CTIL
Study First Received: January 27, 2013
Last Updated: January 30, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
UCP2
Thyroid function
Thyroid carcinoma

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
 Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013