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

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

    • California
      • Los Angeles, California, United States, 90027-6062
        • Children's Hospital Los Angeles

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
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.

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
Baseline and up to 1 year
Change from Baseline in Visceral Adipose Tissue Volume at Follow-up
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
Change from Baseline in Presence of Brown Adipose Tissue
Time Frame: Baseline and up to 1 year
Baseline and up to 1 year
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
Age, height, weight and BMI
Baseline and up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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.

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

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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