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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01517581
Other study ID # CHLA-Gilsanz-BAT/WAT
Secondary ID
Status Completed
Phase N/A
First received January 20, 2012
Last updated January 24, 2012
Start date October 2008
Est. completion date September 2011

Study information

Verified date January 2012
Source Children's Hospital Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 18 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
United States Children's Hospital Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up Baseline and up to 1 year No
Primary Change from Baseline in Visceral Adipose Tissue Volume at Follow-up Baseline and up to 1 year No
Primary Change from Baseline in Presence of Brown Adipose Tissue Baseline and up to 1 year No
Primary Change from Baseline in Abdominal Musculature Volume Baseline and up to 1 year No
Secondary Change from Baseline in Anthropometric Measures at Follow-up Age, height, weight and BMI Baseline and up to 1 year No
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