Thyroid Hormones Effect on Brown Adipose Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01376648
Recruitment Status : Unknown
Verified November 2009 by Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : June 20, 2011
Last Update Posted : June 20, 2011
Information provided by:
Huashan Hospital

Brief Summary:
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 or disease

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
Estimated Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Study on the Relationship Between the Thyroid Hormones and the Activity of Brown Adipose Tissue in Human
Study Start Date : December 2009
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01376648

Contact: Yiming Li, Dr. 862152888055

Huashan Hospital Recruiting
Shanghai, China, 200040
Contact: Zhaoyun Zhang, Dr.   
Principal Investigator: Yiming Li, Dr.         
Sponsors and Collaborators
Huashan Hospital
Study Chair: Yiming Li, Dr. Huashan Hospital

Responsible Party: Yiming Li, Division of Endocrinology and Metabolism Identifier: NCT01376648     History of Changes
Other Study ID Numbers: KY2009-257
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: November 2009

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs