Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT01744769
Status:
UNKNOWN
Last Update Posted:
2012-12-07
First Post:
2012-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer
Sponsor:
Konkuk University Medical Center
Organization:
Study Overview
Official Title:
Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer
Status:
UNKNOWN
Status Verified Date:
2012-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: