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Trial Title:
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer
NCT ID:
NCT01744769
Condition:
Hypothyroidism
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Hypothyroidism
Conditions: Keywords:
thyroid cancer
hypothyroidism
metabolic parameters
Hypothyroidism after levothyroxine withdrawal
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
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.
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
Criteria for eligibility:
Study pop:
the patients who experience severe hypothyroidism after thyroid hormone withdrawal for
radioiodine therapy in differentiated thyroid cancer
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Konkuk University Medical Center
Address:
City:
Seoul
Zip:
143-729
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Jee Hyun An
Phone:
82-10-9089-4655
Email:
jeehyunan@gmail.com
Investigator:
Last name:
Suk Kyoung Kim, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jee Hyun An, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Ki Ho Song, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Dong Lim Kim, MD, PhD
Email:
Sub-Investigator
Start date:
July 2012
Completion date:
May 2013
Lead sponsor:
Agency:
Konkuk University Medical Center
Agency class:
Other
Source:
Konkuk University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01744769
