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Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer

This study is currently recruiting participants.
Verified December 2012 by Konkuk University Medical Center
Sponsor:
Information provided by (Responsible Party):
Suk Kyeong Kim, Konkuk University Medical Center
ClinicalTrials.gov Identifier:
NCT01744769
First received: December 5, 2012
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose
  1. The incidence of differentiated thyroid cancer is increasing in Korea. A significant number of them experience severe hypothyroidism in preparation for radioactive iodine (RAI) therapy after total thyroidectomy.
  2. Because the function of thyroid hormone is closely linked with lipid and glucose metabolism, overt hypothyroidism after thyroid hormone withdrawal during RAI therapy may induce the changes of metabolic parameters.
  3. We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.

Condition
Hypothyroidism

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Konkuk University Medical Center:

Primary Outcome Measures:
  • Changes of metabolic parameters [ Time Frame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy ] [ Designated as safety issue: No ]
    • glucose profiles : HbA1c, fasting glucose level
    • lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride
    • adipocytokines : retinol binding protein(RBP)4, leptin, resistin, adiponectin
    • markers of endothelial and cardiac function : high-sensitivity C-reactive - protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)


Secondary Outcome Measures:
  • Changes of bone turnover markers [ Time Frame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy ] [ Designated as safety issue: No ]
    • bone formation marker: bone ALP
    • bone resorption marker: CTX


Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hypothyroidism for RAI
The group of patients who experience hypothyroidism after thyroid hormone withdrawal for radioactive iodine(RAI) therapy

Detailed Description:
  1. Study design measurement of various parameters during hypothyroid state (before 1 month, the day and after 1 month of RAI therapy)

  2. Measurements

    1. Measurement of metabolic and cardiovascular parameters

      • glucose profiles : HbA1c, fasting glucose level
      • lipid profiles : free fatty acid, total, LDL-, HDL-, cholesterol, triglyceride
      • adipocytokines : retinol binding protein(RBP)
      • 4, leptin, resistin, adiponectin
      • markers of endothelial and cardiac function : high-sensitivity C-reactive protein(hsCRP), homocystein, B-type natriuretic peptide(BNP)
      • bone turnover markers : CTX, bone ALP

    2. Scoring of symptoms and signs of hypothyroidism (Zulewski score)

      • symptoms
      • physical signs
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

the patients who experience severe hypothyroidism after thyroid hormone withdrawal for radioiodine therapy in differentiated thyroid cancer

Criteria

Inclusion Criteria:

  • radioiodine therapy after total thyroidectomy in differentiated thyroid cancer
  • age over 18

Exclusion Criteria:

  • kidney failure, liver failure, heart failure
  • infection
  • inflammation
  • autoimmune disease
  • other chronic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744769

Contacts
Contact: Suk Kyeong Kim, MD, PhD 82-2-2030-7531 20120137@kuh.ac.kr
Contact: Jee Hyun An, MD, PhD 82-10-9089-4655 jeehyunan@gmail.com

Locations
Korea, Republic of
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 143-729
Contact: Jee Hyun An     82-10-9089-4655     jeehyunan@gmail.com    
Principal Investigator: Suk Kyoung Kim, MD, PhD            
Sub-Investigator: Jee Hyun An, MD, PhD            
Sub-Investigator: Ki Ho Song, MD, PhD            
Sub-Investigator: Dong Lim Kim, MD, PhD            
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
Principal Investigator: Suk Kyeong Kim, MD, PhD Konkuk University Medical Center
  More Information

No publications provided

Responsible Party: Suk Kyeong Kim, Associate professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01744769     History of Changes
Other Study ID Numbers: KUH1010379
Study First Received: December 5, 2012
Last Updated: December 6, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Konkuk University Medical Center:
thyroid cancer
hypothyroidism
metabolic parameters
Hypothyroidism after levothyroxine withdrawal

Additional relevant MeSH terms:
Hypothyroidism
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Hormones
Iodine
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013