Body Composition, Brown Adipose Tissue
Conditions
Keywords
neonates, brown adipose tissue, body composition
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.
Interventions
None listed
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
14 Days to 28 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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%. |
| 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 22.6 days STANDARD_DEVIATION 1.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Gestational Age at Birth | 39.129 weeks STANDARD_DEVIATION 1.296 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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%.
Time frame: 1 day
Population: One scan was not analyzed. The scan was completed but did not provide valid data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Average Brown Adipose Tissue Volume at First Visit | 5.41 cubic centimeters | Standard Deviation 0.88 |
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%.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Average Brown Adipose Tissue Volume at Second Visit | 5.50 cubic centimeters | Standard Deviation 1.3 |
Primary
Whole Body Fat Mass
Whole body fat mass will be measured in infant subjects using dual energy x-ray absorptiometry.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Whole Body Fat Mass | 20.8 percentage of fat mass | Standard Deviation 1.8 |
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.
Time frame: 1 day
Population: One scan was not analyzed. The scan was completed but did not provide valid data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Average Fat Signal Fraction of Brown Adipose Tissue at First Visit | 16.64 Percentage of lipid | Standard Deviation 3.31 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit | 16.43 Percentage of lipid | Standard Deviation 3.41 |
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.
Time frame: 2 days within 10 days apart
Population: One scan was not analyzed. The scan was completed but did not provide valid data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit | 0.92 intraclass correlation coefficient |