Measurement of Body Fat in Infants

NCT03490227 | Completed Results

• 1 other identifier: PBRC 2017-050
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Brown Adipose Tissue; Body Composition

Keywords

neonates; brown adipose tissue; body composition

Outcome Measures

Primary Outcomes (3)

• Whole Body Fat Mass

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

  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%.

  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%.

  1 day

Secondary Outcomes (3)

• Average Fat Signal Fraction of Brown Adipose Tissue at First Visit

  1 day

• Average Fat Signal Fraction of Brown Adipose Tissue at Second Visit

  1 day

• Reliability of Average Brown Adipose Tissue Volume Measurement Between the First and Second Visit

  2 days within 10 days apart

Eligibility Criteria

• Age: 14 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Leanne Redman
• Organization: Pennington Biomedical Research Center

leanne.redman@pbrc.edu

225-763-0947

Study Officials

• Leanne M Redman, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 6, 2018
• Study Start: April 30, 2018
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: December 7, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)