Brown Adipose TissueBaby Fat PilotNCT03490227

Measurement of Body Fat in Infants

An observational study of Brown Adipose Tissue and Body Composition, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Up to 10 infants will complete the study aimed to establish a technique for measuring whole body adiposity and brown adipose tissue in infant subjects using dual energy x-ray absorptiometry and magnetic resonance imaging, respectively. Read more about this study

Who is it for?: Ages 14 to 28 daysHealthy volunteers can take part
Conditions the study is for: Brown Adipose Tissue, Body Composition
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2018to 2 Dec 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 14 to 28 days
All sexes
Healthy volunteers accepted
Child

Study population: Up to 10 healthy, full term infants aged 14 to 28 days old at enrollment with no contraindications to MRI will be recruited to Pennington Biomedical Research Center to participate in this study which includes two study visits to be completed within 1-10 days apart.

Who may be able to join

healthy, full-term infant
aged 14-28 days at Visit 1

Who cannot join

born preterm (<37 weeks gestation)
implanted metal or electronic objects that render MRI unsafe
unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center

Trial locations and contacts

1 site in 1 country.

United States1 site

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Conditions: Brown Adipose Tissue, Body Composition
Keywords: neonates, brown adipose tissue, body composition

What is being measured

The primary outcome is the main question the study is designed to answer.

Whole Body Fat Mass
Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.
Measured: 1 day
Average Brown Adipose Tissue Volume at First Visit
Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%.
Measured: 1 day
Average Brown Adipose Tissue Volume at Second Visit
Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%.
Measured: 1 day

Secondary outcomes (3)

Average Fat Signal Fraction of Brown Adipose Tissue at First Visit
Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue.
Measured: 1 day
Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit
Magnetic resonance imaging scans were traced for lipid: water ratio in the supraclavicular region. Fat signal fraction is defined as the lipid: water ratio found in the lipid tissues in the supraclavicular region. Only traced lipid tissues (between 10-50%) were included in the average fat signal fraction because only traced lipid tissues were classified as brown adipose tissue.
Measured: 1 day
Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit
Reliability of average brown adipose tissue volume measurement between visits was determined using intraclass correlation coefficient. Paired average brown adipose tissue volume measurements were included in the intraclass correlation coefficient computation.
Measured: 2 days within 10 days apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 20182 Dec 2019

First posted6 Apr 2018
Study start30 Apr 2018
Primary completion2 Dec 2019
Study completion2 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Brown Adipose TissueStudies 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: Cross-sectional
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03490227
Sponsor's protocol ID: PBRC 2017-050
Acronym: Baby Fat Pilot
Status last verified: Dec 2021
First submitted: 29 Mar 2018
Last updated: 7 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women
Cardiometabolic Diseases, Postmenopause
RecruitingObservational study
Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
Brown Adipose Tissue (BAT) Physiology, Phenotyping
RecruitingPhase 2
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
Atrial Fibrillation (AF)
Recruiting
Brown Adipose Tissue Activation by Spinal Cord Stimulation
Pain, Back, Obesity, Morbid
Not yet recruiting
Brown Adipose Tissue as a Mechanistic Determinant of Semaglutide Treatment Response in Obesity (BAT-Sema Study)
Obesity, Metabolic Syndrome

All Brown Adipose Tissue trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement of Body Fat in Infants
ClinicalTrials.gov ID: NCT03490227
Acronym / sponsor ID: Baby Fat Pilot / PBRC 2017-050
Conditions: Brown Adipose Tissue, Body Composition
Keywords: neonates, brown adipose tissue, body composition
Study type: Observational
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Pennington Biomedical Research CenterUniversity, hospital or other
Study start: 30 Apr 2018 (actual)
Primary completion: 2 Dec 2019 (actual)
Study completion: 2 Dec 2019 (actual)
First posted: 6 Apr 2018 (actual)
Results: Posted 12 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 14 to 28 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Up to 10 healthy, full term infants aged 14 to 28 days old at enrollment with no contraindications to MRI will be recruited to Pennington Biomedical Research Center to participate in this study which includes two study visits to be completed within 1-10 days apart.

Key inclusion criteria (2 listed)

healthy, full-term infant
aged 14-28 days at Visit 1

Key exclusion criteria (3 listed)

born preterm (<37 weeks gestation)
implanted metal or electronic objects that render MRI unsafe
unable to complete 2 clinic visits 1-10 days apart at Pennington Biomedical Research Center

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

Whole Body Fat Mass
Time frame: 1 day
Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.
Average Brown Adipose Tissue Volume at First Visit
Time frame: 1 day
Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%.
Average Brown Adipose Tissue Volume at Second Visit
Time frame: 1 day
Magnetic resonance imaging were traced for lipid: water ratio in the supraclavicular region. Brown adipose tissue volume was calculated by summing all brown adipose tissue volume in the supraclavicular region with a lipid: water ration (or fat signal fraction) between 10-50%.

3 secondary outcomes

Average Fat Signal Fraction of Brown Adipose Tissue at First Visit
Time frame: 1 day
Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit
Time frame: 1 day
Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit
Time frame: 2 days within 10 days apart

Results and safety

Results posted to the registry on 12 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	10	10

Primary outcome: Whole Body Fat Mass

Time frame: 1 day. Mean (Standard Deviation). Unit: percentage of fat mass

Measure	All Participants n = 10
Value	20.8 (1.8)

Primary outcome: Average Brown Adipose Tissue Volume at First Visit

Time frame: 1 day. Mean (Standard Deviation). Unit: cubic centimeters

Measure	All Participants n = 9
Value	5.41 (0.88)

Population analysed: One scan was not analyzed. The scan was completed but did not provide valid data.

Primary outcome: Average Brown Adipose Tissue Volume at Second Visit

Time frame: 1 day. Mean (Standard Deviation). Unit: cubic centimeters

Measure	All Participants n = 10
Value	5.50 (1.30)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Limitations and caveats (from the sponsor): During one MRI scan occurring at the respective participant's first visit, a magnetic resonance imaging (MRI) machine malfunction led to acquisition of images that were unanalyzable and therefore unusable. The study is limited by a small and relatively homogenous sample of ten infants. Given the nature of the method development study, we did not enroll equal numbers of males and females.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Brown Adipose Tissue

Not yet recruiting
Exercise and Prolonged Fasting to Improve Brown Adipose Tissue Function in Postmenopausal Women
Cardiometabolic Diseases, Postmenopause
RecruitingObservational study
Molecular, Cellular, and Genetic Characterization of Human Adipose Tissue and Its Role in Metabolism
Brown Adipose Tissue (BAT) Physiology, Phenotyping
RecruitingPhase 2
Finerenone After Catheter Ablation to Reduce Atrial Fibrillation Recurrence
Atrial Fibrillation (AF)
Recruiting
Brown Adipose Tissue Activation by Spinal Cord Stimulation
Pain, Back, Obesity, Morbid
Not yet recruiting
Brown Adipose Tissue as a Mechanistic Determinant of Semaglutide Treatment Response in Obesity (BAT-Sema Study)
Obesity, Metabolic Syndrome

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.

Leanne M Redman, Ph.D. principal investigator

Pennington Biomedical Research Center

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 Brown Adipose Tissue and Body Composition, run by Pennington Biomedical Research Center 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 2 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 7 Dec 2021. 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?

Yes. Results are posted in the registry (first posted 12 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Whole Body Fat Mass (time frame: 1 day). The study lists 3 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 NCT03490227.

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 7 Dec 2021.