Thyroid Hormones Effect on Brown Adipose Tissue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Huashan Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Huashan Hospital
ClinicalTrials.gov Identifier:
NCT01376648
First received: June 17, 2011
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition
Hyperthyroidism

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study on the Relationship Between the Thyroid Hormones and the Activity of Brown Adipose Tissue in Human

Resource links provided by NLM:


Further study details as provided by Huashan Hospital:

Biospecimen Retention:   Samples Without DNA

TSH, TT3, TT4, fT3, fT4, γT3,Norepinephrine,Blood-fat,FPG,Insulin,Leptin,Aadiponectin,Retinol-binding protein 4,Fatty acid binding protein 4,IL-6,TNF-α,CRP,Monocyte chemotactic protein 1


Estimated Enrollment: 20
Study Start Date: December 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376648

Contacts
Contact: Yiming Li, Dr. 862152888055 yimingli@fudan.edu.cn

Locations
China
Huashan Hospital Recruiting
Shanghai, China, 200040
Contact: Zhaoyun Zhang, Dr.       zhaoyunzhang@fudan.edu.cn   
Principal Investigator: Yiming Li, Dr.         
Sponsors and Collaborators
Huashan Hospital
Investigators
Study Chair: Yiming Li, Dr. Huashan Hospital, Fudan University
  More Information

No publications provided

Responsible Party: Yiming Li, Division of Endocrinology and Metabolism
ClinicalTrials.gov Identifier: NCT01376648     History of Changes
Other Study ID Numbers: KY2009-257
Study First Received: June 17, 2011
Last Updated: June 17, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014