An Examination of Brown Adipose Tissue and Energy Expenditure in Infants (Born2Burn)

Excess fetal adipose tissue growth during intrauterine development increases future obesity risk. Development of brown adipose tissue, a highly thermogenic organ in utero, may affect postnatal energy expenditure, thus influencing obesity risk. This research study is designed to understand the developmental origins of energy balance by examining maternal and neonatal factors that influence neonatal brown adipose tissue and to quantify its physiological relevance to energy expenditure in human neonates.

Study Overview

• Status: Recruiting
• Conditions: Brown Adipose Tissue

Detailed Description

The developmental origins of obesity begin in utero with growth and differentiation of adipose tissue. Fetal white adipose tissue accretion is highly variable and dependent on the maternal intrauterine environment. Unlike white adipose tissue, brown adipose tissue has a high capacity for thermogenesis. Brown adipose tissue is present at birth and it is believed to support the critical function of thermoregulation in early postnatal life. Therefore, Brown adipose tissue may also influence the development of neonatal energy balance. Similar to white adipose tissue, it is hypothesized that development of Brown adipose tissue in utero is also influenced by maternal factors such as prepregnancy body mass index and gestational weight gain. The research aims of this study to 1) identify maternal and neonatal factors that contribute to neonatal Brown adipose tissue and 2) to identify changes in neonatal Brown adipose tissue and to energy expenditure in response to a mild cold exposure. To achieve these aims, we will conduct a cross-sectional, observational study in up to 60 infants 0-3 weeks of age. Using state-of-the-art methodology, we will assess brown adipose tissue, body composition, and resting metabolic rate under thermoneutral and mild-cold stimulated conditions.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Emily W Flanagan, PhD; Phone Number: 225-763-2828; Email: emily.flanagan@pbrc.edu
• Study Contact Backup: Name: Abby D Altazan, MS; Phone Number: 225-763-2801; Email: abby.duhe@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Pennington Biomedical Research Center
      • Contact: Emily W Flanagan, PhD; Phone Number: 225-763-2828; Email: emily.flanagan@pbrc.edu
      • Contact: Abby D Altazan, MS; Phone Number: 225-763-2801; Email: abby.duhe@pbrc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

This study will enroll neonates from two mechanisms: 1) recruited from the greater Baton Rouge area, and 2) recruited from an ongoing prenatal weight maintenance intervention randomized controlled trial (R01DK099175).

Description

Inclusion Criteria:

• aged 0 weeks to less than 3 weeks at visit 1
• be willing to complete MRI procedures

Exclusion Criteria:

• Unable to complete two clinic visits within 14 days
• Born with health conditions that would render the procedures unsafe
• Born earlier than 36 and 0 days gestation
• Taken a steroid drug since birth
• Implanted metal or electronic objects that render MRI unsafe

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brown Adipose Tissue Fat-signal Fraction Difference Between Thermoneutral and Mild-Cold Environment	The difference in the infants' fat-signal fraction (ratio of lipid to water, expressed as a percentage), assessed by Magnetic Resonance Imaging, between a thermoneutral environment and a mild-cold exposure.	14 days
Energy Expenditure Difference Between Thermoneutral and Mild-Cold Environment	The difference in the infants' energy expenditure (expressed as kilocalories per day), assessed by room calorimetry, between a thermoneutral environment and a mild-cold exposure.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brown Adipose Tissue Volume Difference Between Mothers Enrolled in Prenatal Intervention	In an ancillary aim of the study, we will examine the difference in the infants' brown adipose tissue volume (expressed as cubic centimeters), assessed by Magnetic Resonance Imaging, between infants born to mothers enrolled in a prenatal weight maintenance intervention (R01DK124806) and infants born to mothers seeking routine prenatal care.	1 day

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Emily W Flanagan, PhD, Pennington Biomedical Research Center

Publications and helpful links

General Publications

• Flanagan EW, Altazan AD, Carmichael OT, Hu HH, Redman LM. Practical application of in vivo MRI-based brown adipose tissue measurements in infants. Obesity (Silver Spring). 2021 Oct;29(10):1676-1683. doi: 10.1002/oby.23237.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging; Infant; Energy Expenditure; Neonatal; Brown Fat; Indirect Calorimetry
• Other Study ID Numbers: PBRC 2021-054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No