Brown Fat Activity and White Fat Accumulation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Vicente Gilsanz, Children's Hospital Los Angeles

ClinicalTrials.gov Identifier:

NCT01517581

First received: January 20, 2012

Last updated: January 24, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

January 20, 2012

Last Updated Date

January 24, 2012

Start Date ^ICMJE

October 2008

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up [ Time Frame: Baseline and up to 1 year ] [ Designated as safety issue: No ]
Change from Baseline in Visceral Adipose Tissue Volume at Follow-up [ Time Frame: Baseline and up to 1 year ] [ Designated as safety issue: No ]
Change from Baseline in Presence of Brown Adipose Tissue [ Time Frame: Baseline and up to 1 year ] [ Designated as safety issue: No ]
Change from Baseline in Abdominal Musculature Volume [ Time Frame: Baseline and up to 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01517581 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from Baseline in Anthropometric Measures at Follow-up [ Time Frame: Baseline and up to 1 year ] [ Designated as safety issue: No ]

Age, height, weight and BMI

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Brown Fat Activity and White Fat Accumulation

Official Title ^ICMJE

Study on the Association Between Brown Adipose Tissue Activation and White Adipose Tissue Accumulation in Successfully Treated Pediatric Malignancy

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with a history of malignancy such that they are required to undergo PET/CT exams.

Condition ^ICMJE

Hodgkins Lymphoma
Non-hodgkins Lymphoma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01517581

Other Study ID Numbers ^ICMJE

CHLA-Gilsanz-BAT/WAT

Has Data Monitoring Committee

Responsible Party

Vicente Gilsanz, Children's Hospital Los Angeles

Study Sponsor ^ICMJE

Children's Hospital Los Angeles

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Vicente Gilsanz, MD, PhD

Children's Hospital Los Angeles

Information Provided By

Children's Hospital Los Angeles

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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