Trial Outcomes & Findings for Measurement of Body Fat in Infants (NCT NCT03490227)

NCT ID: NCT03490227

Last Updated: 2021-12-07

Results Overview

Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

1 day

Results posted on

2021-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measurement of Body Fat in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=10 Participants This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue.
Age, Continuous	22.6 days STANDARD_DEVIATION 1.31 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Gestational Age at Birth	39.129 weeks STANDARD_DEVIATION 1.296 • n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.

Outcome measures

Outcome measures
Measure	All Participants n=10 Participants This is an observational study where all participants did DXA once in order to assess infant body composition.
Whole Body Fat Mass	20.8 percentage of fat mass Standard Deviation 1.8

PRIMARY outcome

Timeframe: 1 day

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

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%.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants This is an observational study where all participants did DXA once in order to assess infant body composition.
Average Brown Adipose Tissue Volume at First Visit	5.41 cubic centimeters Standard Deviation 0.88

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	All Participants n=10 Participants This is an observational study where all participants did DXA once in order to assess infant body composition.
Average Brown Adipose Tissue Volume at Second Visit	5.50 cubic centimeters Standard Deviation 1.30

SECONDARY outcome

Timeframe: 1 day

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

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.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants This is an observational study where all participants did DXA once in order to assess infant body composition.
Average Fat Signal Fraction of Brown Adipose Tissue at First Visit	16.64 Percentage of lipid Standard Deviation 3.31

SECONDARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	All Participants n=10 Participants This is an observational study where all participants did DXA once in order to assess infant body composition.
Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit	16.43 Percentage of lipid Standard Deviation 3.41

SECONDARY outcome

Timeframe: 2 days within 10 days apart

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

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.

Outcome measures

Outcome measures
Measure	All Participants n=9 Participants This is an observational study where all participants did DXA once in order to assess infant body composition.
Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit	0.92 intraclass correlation coefficient Interval 0.65 to 0.98

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=10 participants at risk This is an observational study where all participants did DXA once and MRI twice in order to assess infant body composition and brown adipose tissue.
Gastrointestinal disorders Flatulence	10.0% 1/10 • Number of events 1 • 10 days

Additional Information

Dr. Leanne Redman

Pennington Biomedical Research Center

Phone: 225-763-0947

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place