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

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.

Study Overview

• Status: Unknown
• Conditions: Hypothyroidism

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

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 143-729
    • Recruiting
    • Konkuk University Medical Center
    • Contact: Jee Hyun An; Phone Number: 82-10-9089-4655; Email: jeehyunan@gmail.com
    • Principal Investigator: Suk Kyoung Kim, MD, PhD
    • Sub-Investigator: Jee Hyun An, MD, PhD
    • Sub-Investigator: Ki Ho Song, MD, PhD
    • Sub-Investigator: Dong Lim Kim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Hypothyroidism for RAI; The group of patients who experience hypothyroidism after thyroid hormone withdrawal for radioactive iodine(RAI) therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Principal Investigator: Suk Kyeong Kim, MD, PhD, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (Estimate): December 7, 2012

Study Record Updates

• Last Update Posted (Estimate): December 7, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: thyroid cancer; hypothyroidism; metabolic parameters; Hypothyroidism after levothyroxine withdrawal
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Hypothyroidism; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: KUH1010379