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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01744769

Enrollment

Registered

2012-12-07

Start date

2012-07-31

Completion date

2013-05-31

Last updated

2012-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism

Keywords

thyroid cancer, hypothyroidism, metabolic parameters, Hypothyroidism after levothyroxine withdrawal

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactSuk Kyeong Kim, MD, PhD

20120137@kuh.ac.kr82-2-2030-7531

Backup ContactJee Hyun An, MD, PhD

jeehyunan@gmail.com82-10-9089-4655

Outcome results