Clinical trial NCT01744769: Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer
Official title: Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothyroidism
Keywords: thyroid cancer
hypothyroidism
metabolic parameters
Hypothyroidism after levothyroxine withdrawal
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2012-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who experience severe hypothyroidism after thyroid hormone withdrawal for radioiodine therapy in differentiated thyroid cancer

Brief summary: 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.

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 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

Primary outcomes:
measure: Changes of metabolic parameters
timeFrame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy
Secondary outcomes:
measure: Changes of bone turnover markers
timeFrame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Suk Kyeong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: