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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01744769
• Other study ID #: KUH1010379
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2012
• Last updated: December 6, 2012
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: December 2012
• Source: Konkuk University Medical Center
• Contact: Suk Kyeong Kim, MD, PhD
• Phone: 82-2-2030-7531
• Email: 20120137[@]kuh.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypothyroidism
• Thyroid Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of metabolic 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)	Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy	No
Secondary	Changes of bone turnover markers	bone formation marker: bone ALP; bone resorption marker: CTX	Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy	No