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

NCT01744769 | Unknown

• 1 other identifier: KUH1010379
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.

Conditions

Hypothyroidism

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Changes of bone turnover markers

  Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy

Study Arms (1)

Hypothyroidism for RAI

The group of patients who experience hypothyroidism after thyroid hormone withdrawal for radioactive iodine(RAI) therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the patients who experience severe hypothyroidism after thyroid hormone withdrawal for radioiodine therapy in differentiated thyroid cancer

You may qualify if:

• radioiodine therapy after total thyroidectomy in differentiated thyroid cancer
• age over 18

You may not qualify if:

• kidney failure, liver failure, heart failure
• infection
• inflammation
• autoimmune disease
• other chronic disease

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Hypothyroidism; Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Study Officials

• Suk Kyeong Kim, MD, PhD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suk Kyeong Kim, MD, PhD

CONTACT

82-2-2030-7531; 20120137@kuh.ac.kr

Jee Hyun An, MD, PhD

CONTACT

82-10-9089-4655; jeehyunan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 7, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 7, 2012

Record last verified: 2012-12

Locations

KR (1)