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

NCT ID: NCT01744769

Last Updated: 2012-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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

Conditions

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Hypothyroidism

Keywords

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thyroid cancer hypothyroidism metabolic parameters Hypothyroidism after levothyroxine withdrawal

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypothyroidism for RAI

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Suk Kyeong Kim

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suk Kyeong Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Locations

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Konkuk University Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Suk Kyeong Kim, MD, PhD

Role: CONTACT

Phone: 82-2-2030-7531

Email: [email protected]

Jee Hyun An, MD, PhD

Role: CONTACT

Phone: 82-10-9089-4655

Email: [email protected]

Facility Contacts

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Jee Hyun An

Role: primary

Other Identifiers

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KUH1010379

Identifier Type: -

Identifier Source: org_study_id