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Status unknownNCT01744769Updated Dec 7, 2012

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

An observational study in Hypothyroidism, sponsored by Konkuk University Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-12-07.

Sponsored by Konkuk University Medical Center · Observational

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 80 Years
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Hypothyroidism

Keywords

  • thyroid cancer
  • hypothyroidism
  • metabolic parameters
  • Hypothyroidism after levothyroxine withdrawal
03

In context

Thyroid Neoplasms

802 studies on the registry are indexed under Thyroid Neoplasms; 216 are open to participants now.

This study's planned enrollment of 80 is below the median of 172 across 261 observational studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Konkuk University Medical Center is the lead sponsor of 93 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • kidney failure, liver failure, heart failure
  • infection
  • inflammation
  • autoimmune disease
  • other chronic disease
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Hypothyroidism for RAI

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

06

What researchers measure

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)

    Time frame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy

Secondary outcomes

  1. Changes of bone turnover markers

    * bone formation marker: bone ALP * bone resorption marker: CTX

    Time frame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy

07

Study locations

1 of 1 sites recruiting
  • Konkuk University Medical Center
    Seoul, 143-729, Korea, Republic of
    • Jee Hyun An · Contact · jeehyunan@gmail.com · 82-10-9089-4655
    • Suk Kyoung Kim, MD, PhD · Principal investigator
    • Jee Hyun An, MD, PhD · Sub investigator
    • Ki Ho Song, MD, PhD · Sub investigator
    • Dong Lim Kim, MD, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01744769
Lead sponsor
Konkuk University Medical Center
Responsible party
Suk Kyeong Kim (Associate professor, Konkuk University Medical Center) — Principal investigator
First posted
Dec 7, 2012
Start date
Jul 2012
Primary completion
May 2013 (estimated)
Completion
May 2013 (estimated)
Last update
Dec 7, 2012

Study contacts

Suk Kyeong Kim, MD, PhD
Contact
20120137@kuh.ac.kr
82-2-2030-7531
Jee Hyun An, MD, PhD
Contact
jeehyunan@gmail.com
82-10-9089-4655
Suk Kyeong Kim, MD, PhD
principal investigator · Konkuk University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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