- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01517581
Brown Fat Activity and White Fat Accumulation
January 24, 2012 updated by: Vicente Gilsanz, Children's Hospital Los Angeles
Study on the Association Between Brown Adipose Tissue Activation and White Adipose Tissue Accumulation in Successfully Treated Pediatric Malignancy
White and brown adipocytes differ in their expression of hormones, cytokines, and inflammatory factors, and they modulate different biological functions.
While white adipose tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT) instead metabolizes fat to produce heat and regulate body temperature.
BAT is likely present in all humans, but the low prevalence of BAT depiction in adults and elderly subjects has hindered longitudinal assessments of the relation between BAT activity and WAT.
Under typical imaging conditions, BAT is detected more frequently in children and teenagers than in adults with malignancy.
Since most children with cancer have significantly shorter treatment courses and greater survival rates compared to adult patients, the investigators have the ability to examine the relation of repeated measures of body composition and BAT by selecting pediatric patients.
In this study, the investigators will longitudinally examine whether BAT activity is related to changes in weight and the amounts of SAT, VAT, and abdominal muscle in children successfully treated for pediatric cancer.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Los Angeles, California, United States, 90027-6062
- Children's Hospital Los Angeles
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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
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pediatric patients with a history of malignancy such that they are required to undergo PET/CT exams.
Description
Inclusion Criteria:
- Patients had PET/CT scans with evidence of malignant disease
- Patients had no metabolically active BAT at diagnosis on their PET/CT scan
- Patients were disease free within 1 year of diagnosis
Exclusion Criteria:
- Patients had PET/CT scans with no evidence of malignant disease
- Patients with metabolically active BAT at diagnosis on their PET/CT scan
- Patients were not disease free within 1 year of diagnosis
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
Cohorts and Interventions
Group / Cohort |
|---|
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Malignant Disease with no visualized BAT
Children 18 years or younger who 1) had PET/CT scans with evidence of malignant disease but no metabolically active brown adipose tissue (BAT) at diagnosis and 2) were disease free within 1 year of diagnosis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up
Time Frame: Baseline and up to 1 year
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Baseline and up to 1 year
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Change from Baseline in Visceral Adipose Tissue Volume at Follow-up
Time Frame: Baseline and up to 1 year
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Baseline and up to 1 year
|
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Change from Baseline in Presence of Brown Adipose Tissue
Time Frame: Baseline and up to 1 year
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Baseline and up to 1 year
|
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Change from Baseline in Abdominal Musculature Volume
Time Frame: Baseline and up to 1 year
|
Baseline and up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Anthropometric Measures at Follow-up
Time Frame: Baseline and up to 1 year
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Age, height, weight and BMI
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Baseline and up to 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vicente Gilsanz, MD, PhD, Children's Hospital Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hamilton G, Smith DL Jr, Bydder M, Nayak KS, Hu HH. MR properties of brown and white adipose tissues. J Magn Reson Imaging. 2011 Aug;34(2):468-73. doi: 10.1002/jmri.22623.
- Gilsanz V, Chung SA, Jackson H, Dorey FJ, Hu HH. Functional brown adipose tissue is related to muscle volume in children and adolescents. J Pediatr. 2011 May;158(5):722-6. doi: 10.1016/j.jpeds.2010.11.020. Epub 2010 Dec 18.
- Gilsanz V, Smith ML, Goodarzian F, Kim M, Wren TA, Hu HH. Changes in brown adipose tissue in boys and girls during childhood and puberty. J Pediatr. 2012 Apr;160(4):604-609.e1. doi: 10.1016/j.jpeds.2011.09.035. Epub 2011 Nov 1.
- Gilsanz V, Chung SA, Kaplowitz N. Differential effect of gender on hepatic fat. Pediatr Radiol. 2011 Sep;41(9):1146-53. doi: 10.1007/s00247-011-2021-7. Epub 2011 Mar 15.
- Hu HH, Chung SA, Nayak KS, Jackson HA, Gilsanz V. Differential computed tomographic attenuation of metabolically active and inactive adipose tissues: preliminary findings. J Comput Assist Tomogr. 2011 Jan-Feb;35(1):65-71. doi: 10.1097/RCT.0b013e3181fc2150.
- Chalfant JS, Smith ML, Hu HH, Dorey FJ, Goodarzian F, Fu CH, Gilsanz V. Inverse association between brown adipose tissue activation and white adipose tissue accumulation in successfully treated pediatric malignancy. Am J Clin Nutr. 2012 May;95(5):1144-9. doi: 10.3945/ajcn.111.030650. Epub 2012 Mar 28.
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
October 1, 2008
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
January 20, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (Estimate)
January 25, 2012
Study Record Updates
Last Update Posted (Estimate)
January 25, 2012
Last Update Submitted That Met QC Criteria
January 24, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHLA-Gilsanz-BAT/WAT
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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