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

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:
NCT01781767
First received: January 27, 2013
Last updated: January 30, 2013
Last verified: January 2013
  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:


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
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: 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 July 28, 2014