HypothyroidismNCT01744769
Effects of Thyroid Hormone Withdrawal on Metabolic Parameters During Radioactive Iodine Therapy in Thyroid Cancer
An observational study of Hypothyroidism, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypothyroidism
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients who experience severe hypothyroidism after thyroid hormone withdrawal for radioiodine therapy in differentiated thyroid cancer
Who may be able to join
- radioiodine therapy after total thyroidectomy in differentiated thyroid cancer
- age over 18
Who cannot join
- kidney failure, liver failure, heart failure
- infection
- inflammation
- autoimmune disease
- other chronic disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul, 143-729
Jee Hyun An, 82-10-9089-4655, jeehyunan@gmail.com
Suk Kyoung Kim, MD, PhD
About this study
Official title: Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer
- 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.
- 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.
- 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
- Study design measurement of various parameters during hypothyroid state (before 1 month, the day and after 1 month of RAI therapy)
- Measurements
- 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
- Scoring of symptoms and signs of hypothyroidism (Zulewski score)
- symptoms
- physical signs
- Conditions
- Hypothyroidism
- Keywords
- thyroid cancer, hypothyroidism, metabolic parameters, Hypothyroidism after levothyroxine withdrawal
- Medical subject headings
- Hypothyroidism, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypothyroidism for RAI | The group of patients who experience hypothyroidism after thyroid hormone withdrawal for radioactive iodine(RAI) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suk Kyeong Kim, Konkuk University Medical Center
- Investigators
- Suk Kyeong Kim, MD, PhD, Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744769
- Sponsor's protocol ID
- KUH1010379
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Thyroid Hormone Withdrawal on Metabolic and Cardiovascular Parameters During Radioactive Iodine Therapy in Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT01744769
- Acronym / sponsor ID
- KUH1010379
- Conditions
- Hypothyroidism
- Keywords
- thyroid cancer, hypothyroidism, metabolic parameters, Hypothyroidism after levothyroxine withdrawal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 7 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- We investigate the effects of thyroid hormone withdrawal on metabolic and cardiovascular parameters during radioactive iodine therapy in differentiated thyroid cancer.
Detailed description
- Study design measurement of various parameters during hypothyroid state (before 1 month, the day and after 1 month of RAI therapy)
- Measurements
- 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
- Scoring of symptoms and signs of hypothyroidism (Zulewski score)
- symptoms
- physical signs
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypothyroidism for RAI | – | –The group of patients who experience hypothyroidism after thyroid hormone withdrawal for radioactive iodine(RAI) therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients who experience severe hypothyroidism after thyroid hormone withdrawal for radioiodine therapy in differentiated thyroid cancer
Key inclusion criteria (2 listed)
- radioiodine therapy after total thyroidectomy in differentiated thyroid cancer
- age over 18
Key exclusion criteria (5 listed)
- kidney failure, liver failure, heart failure
- infection
- inflammation
- autoimmune disease
- other chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of metabolic parameters
Time frame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy
* 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)
1 secondary outcome
Changes of bone turnover markers
Time frame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine terapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
Related trials for Hypothyroidism
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
RecruitingObservational study
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Congenital Disorders of Glycosylation
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suk Kyeong Kim, MD, PhD principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suk Kyeong Kim, MD, PhD (82-2-2030-7531, 20120137@kuh.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of metabolic parameters (time frame: Before 1month of radioiodine therapy, Day of radioiodine therapy, After 1 month of radioiodine therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2012.