THYROTOXICOSISNCT02886949
The Association Between Autoimmune or Inflammation and Thyroid Disease
An observational study of THYROTOXICOSIS, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate the effects of thyroid functions on energy homeostasis and inflammation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- THYROTOXICOSIS
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2011to Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a suspicion of thyroid disease.
Who may be able to join
- Subjects visits outpatient department due to a suspicion of thyroid disease
Who cannot join
- Psychological disorders, severe inflammatory or infection diseases.
Trial locations and contacts
1 site in 1 country.
I-Te Lee, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital
Taichang, 407
I-TE Lee, MD, itlee@vghtc.gov.tw
Wayne HH SHEU, MD, PhD, whhsheu@vghtc.gov.tw
About this study
Official title: The Relationship of Vascular Cell Adhesion Molecule 1, C-reactive Protein, Brain-derived Neurotrophic Factor, Orexin and Depressive Symptoms in the Subjects With Thyroid Disease
This study aims to evaluate the effects of thyroid functions on energy homeostasis and inflammation.
Read the detailed description
The subjects were enrolled for evaluation of thyroid functions. The associations between thyroid function and energy homeostasis and inflammation will be assessed.
- Conditions
- THYROTOXICOSIS
- Medical subject headings
- Thyrotoxicosis
What is being measured
The primary outcome is the main question the study is designed to answer.
brain-derived neurotrophic factor
BDNF
Measured: 3 months
Secondary outcomes (8)
vascular cell adhesion molecule 1 (VCAM-1)
Inflammation
Measured: 3 months
C-reactive protein (CRP)
Inflammation
Measured: 3 months
Orexin
Psychological assessment
Measured: 3 month
Zung Self-Rating Depression Scale (Zung SDS)
Depressive symptom
Measured: 3 month
Body composition
fat component
Measured: 3 month
ankle brachial index (ABI)
Arterial stiffness
Measured: 3 months
pulse wave velocity (PWV)
Arterial stiffness
Measured: 3 months
mean arterial pressure (MAP)
Arterial stiffness
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startNov 2011
- Primary completionDec 2020 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THYROTOXICOSISStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- I-Te Lee, MD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886949
- Sponsor's protocol ID
- CE11307
- Status last verified
- Jan 2020
- First submitted
- 2 Sep 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Vascular Cell Adhesion Molecule 1, C-reactive Protein, Brain-derived Neurotrophic Factor, Orexin and Depressive Symptoms in the Subjects With Thyroid Disease
- ClinicalTrials.gov ID
- NCT02886949
- Acronym / sponsor ID
- CE11307
- Conditions
- THYROTOXICOSIS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2016 (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.
This study aims to evaluate the effects of thyroid functions on energy homeostasis and inflammation.
Detailed description
The subjects were enrolled for evaluation of thyroid functions. The associations between thyroid function and energy homeostasis and inflammation will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a suspicion of thyroid disease.
Key inclusion criteria (1 listed)
- Subjects visits outpatient department due to a suspicion of thyroid disease
Key exclusion criteria (1 listed)
- Psychological disorders, severe inflammatory or infection diseases.
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
brain-derived neurotrophic factor
Time frame: 3 months
BDNF
8 secondary outcomes
vascular cell adhesion molecule 1 (VCAM-1)
Time frame: 3 months
C-reactive protein (CRP)
Time frame: 3 months
Orexin
Time frame: 3 month
Zung Self-Rating Depression Scale (Zung SDS)
Time frame: 3 month
Body composition
Time frame: 3 month
ankle brachial index (ABI)
Time frame: 3 months
pulse wave velocity (PWV)
Time frame: 3 months
mean arterial pressure (MAP)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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Thyrotoxicosis
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.
I-Te Lee, MD contact
I-Te Lee, MD principal investigator
Taichung Veterans General Hospital
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 THYROTOXICOSIS, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 Jan 2020. 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 Taiwan. 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 I-Te Lee, MD (itlee@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain-derived neurotrophic factor (time frame: 3 months). 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 Jan 2020; AzTrials last refreshed its copy on 31 Oct 2026.