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

• Conditions: Hypothyroidism

• Registration Number: NCT01744769
• Lead Sponsor: Konkuk University Medical Center

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

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-12
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-06
• Last Update Submitted: 2012-12-06
• Study First Posted: 2012-12-07
• Last Update Posted: 2012-12-07
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of metabolic parameters	Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy	* 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

Name	Time	Method
Changes of bone turnover markers	Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy	* bone formation marker: bone ALP; * bone resorption marker: CTX

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of