Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mehmet Ali Cikrikcioglu, Vakif Gureba Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01102205
First received: April 9, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.


Condition
Hashimoto Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease

Resource links provided by NLM:


Further study details as provided by Vakif Gureba Training and Research Hospital:

Primary Outcome Measures:
  • Poxidative stress markers [ Time Frame: After levotren therapy ] [ Designated as safety issue: No ]
    ...


Biospecimen Retention:   Samples Without DNA

after overnight fasting state,venous blood will be taken to obtain serum.speciemens stored -70 cantigrade celcius untillanalysing.


Enrollment: 130
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy
euthyroid hashimoto
hypothyroid hashimoto

Detailed Description:

oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

adult with Hashimoto disease in euthyroid or subclinical hypothyroid state and healthy control.

Criteria

Inclusion Criteria:

  • age more than 18 years

Exclusion Criteria:

  • inability to give a written consent
  • other conditions and drug usage affect oxidative stress
  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: NCT01102205

Locations
Turkey
Vakif Gureba Training and Research Hospital
Istanbul, Turkey, 34100
Sponsors and Collaborators
Vakif Gureba Training and Research Hospital
Investigators
Study Chair: Mehmet ali Cikrikcioglu, MD vakif gureba TRH,fatih,istanbul,turkey.specialist in internal medicine
  More Information

No publications provided

Responsible Party: Mehmet Ali Cikrikcioglu, Vakif Gureba TRH, Vakif Gureba Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01102205     History of Changes
Other Study ID Numbers: tastoshashi
Study First Received: April 9, 2010
Last Updated: June 11, 2013
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Hashimoto Disease
Thyroiditis, Autoimmune
Thyroiditis
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014