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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03490227
Other study ID # PBRC 2017-050
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 30, 2018
Est. completion date December 2, 2019

Study information

Verified date December 2021
Source Pennington Biomedical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 2, 2019
Est. primary completion date December 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria: - healthy, full-term infant - aged 14-28 days at Visit 1 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Whole Body Fat Mass Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry. 1 day
Primary 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%. 1 day
Primary 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%. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 2 days within 10 days apart
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