Measurement of Body Fat in Infants

Completed

• Conditions: Brown Adipose Tissue; Body Composition

• Registration Number: NCT03490227
• Lead Sponsor: Pennington Biomedical Research Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-06
• Study Start: 2018-04-30
• Primary Completion: 2019-12-02
• Study Completion: 2019-12-02
• Results First Submitted: 2021-09-14
• Results First Submitted QC: 2021-09-14
• Results First Posted: 2021-10-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whole Body Fat Mass	1 day	Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.
Average Brown Adipose Tissue Volume at Second Visit	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 First Visit	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%.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States