An Examination of Brown Adipose Tissue and Energy Expenditure in Infants

Brown Adipose Tissue Clinical Trial

— Born2Burn  

Official title:

An Examination of Brown Adipose Tissue and Energy Expenditure in Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517967
• Other study ID #: PBRC 2021-054
• Status: Recruiting
• Start date: August 17, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Pennington Biomedical Research Center
• Contact: Emily W Flanagan, PhD
• Phone: 225-763-2828
• Email: emily.flanagan[@]pbrc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: N/A to 5 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Brown Adipose Tissue

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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