- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01376648
Thyroid Hormones Effect on Brown Adipose Tissue
June 17, 2011 updated by: Huashan Hospital
Study on the Relationship Between the Thyroid Hormones and the Activity of Brown Adipose Tissue in Human
Brown adipose tissue (BAT) is important in energy expenditure through thermogenesis although the regulatory factors are not well known in humans.
There is evidence suggesting that the thyroid hormones affect BAT functions in lower mammals, but the effects of the thyroid hormones on BAT activity in humans are still unclear.
The objective of this study was to investigate the effects of thyroid hormones on glucose metabolism of BAT and other organs in humans.
Study Overview
Status
Unknown
Conditions
Detailed Description
Twenty consecutive patients with Graves'-caused hyperthyroidism who are newly diagnosed and untreated will be studied at the Endocrine Department of Huashan Hospital, Fudan University.
All subjects are screened and examined by two senior investigators.
Putative BAT activity is determined by the integrated 18F-fluorodeoxyglucose (18F-FDG) PET-CT.
After the first PET scan, hyperthyroid patients will be treated with Methimazole following clinical guidelines.
None of them uses beta adrenergic blockade.
The initial dose of methimazole employed is 10mg thrice a day.
During follow-up, the thyroid hormone levels (free triiodothyronine and free thyroxine) will be measured every twenty days.
The PET-CT scans and assessments will be repeated when the symptoms have disappeared and the thyroid hormone levels return to normal range.
Then the dose of methimazole will be adjusted accordingly.
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yiming Li, Dr.
- Phone Number: 862152888055
- Email: yimingli@fudan.edu.cn
Study Locations
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-
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Shanghai, China, 200040
- Recruiting
- Huashan Hospital
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Contact:
- Zhaoyun Zhang, Dr.
- Email: zhaoyunzhang@fudan.edu.cn
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Principal Investigator:
- Yiming Li, Dr.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Twenty Graves' disease-caused hyperthyroid patients who were newly diagnosed and untreated were included.
All hyperthyroid patients were treated with Methimazole and had been followed up until their symptoms disappeared and the thyroid hormone levels went back to normal range.
Description
Inclusion Criteria:
- Newly diagnosed and untreated hyperthyroid patients
- Informed consent was obtained
Exclusion Criteria:
- History of other endocrine diseases
- Useing beta adrenergic blockade
- Pregnant women
- Pacemaker implantation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (ANTICIPATED)
May 1, 2012
Study Completion (ANTICIPATED)
May 1, 2012
Study Registration Dates
First Submitted
June 17, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (ESTIMATE)
June 20, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
June 20, 2011
Last Update Submitted That Met QC Criteria
June 17, 2011
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2009-257
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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