Hodgkins LymphomaNCT01517581
Brown Fat Activity and White Fat Accumulation
An observational study of Hodgkins Lymphoma and Non-hodgkins Lymphoma, run by Children's Hospital Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hodgkins Lymphoma, Non-hodgkins Lymphoma
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients with a history of malignancy such that they are required to undergo PET/CT exams.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027-6062
About this study
Official title: 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.
- Conditions
- Hodgkins Lymphoma, Non-hodgkins Lymphoma
- Keywords
- Brown adipose tissue
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up
Measured: Baseline and up to 1 year
Change from Baseline in Visceral Adipose Tissue Volume at Follow-up
Measured: Baseline and up to 1 year
Change from Baseline in Presence of Brown Adipose Tissue
Measured: Baseline and up to 1 year
Change from Baseline in Abdominal Musculature Volume
Measured: Baseline and up to 1 year
Secondary outcomes (1)
Change from Baseline in Anthropometric Measures at Follow-up
Age, height, weight and BMI
Measured: Baseline and up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hodgkins LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Gilsanz, Children's Hospital Los Angeles
- Investigators
- Vicente Gilsanz, MD, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517581
- Sponsor's protocol ID
- CHLA-Gilsanz-BAT/WAT
- Status last verified
- Jan 2012
- First submitted
- 20 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21780237Gilsanz 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.
PubMed 21168855Gilsanz 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.
PubMed 22048045Gilsanz 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.
PubMed 21404026Hu 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.
PubMed 21245691Chalfant 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.
PubMed 22456659
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association Between Brown Adipose Tissue Activation and White Adipose Tissue Accumulation in Successfully Treated Pediatric Malignancy
- ClinicalTrials.gov ID
- NCT01517581
- Acronym / sponsor ID
- CHLA-Gilsanz-BAT/WAT
- Conditions
- Hodgkins Lymphoma, Non-hodgkins Lymphoma
- Keywords
- Brown adipose tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients with a history of malignancy such that they are required to undergo PET/CT exams.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up
Time frame: 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
Change from Baseline in Presence of Brown Adipose Tissue
Time frame: Baseline and up to 1 year
Change from Baseline in Abdominal Musculature Volume
Time frame: Baseline and up to 1 year
1 secondary outcome
Change from Baseline in Anthropometric Measures at Follow-up
Time frame: Baseline and up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- Background: PubMed 21780237Hamilton 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.
- Results publication: PubMed 21168855Gilsanz 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.
- Results publication: PubMed 22048045Gilsanz 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.
- Results publication: PubMed 21404026Gilsanz 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.
- Results publication: PubMed 21245691Hu 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.
- Derived from this study: PubMed 22456659Chalfant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicente Gilsanz, MD, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkins Lymphoma and Non-hodgkins Lymphoma, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up (time frame: Baseline and up to 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01517581, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2012.