Clinical trial NCT03219229: Metabolic Effects of Differential Organ Growth Rates
Official title: Metabolic Effects of Differential Organ Growth Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resting Energy Expenditure
Keywords: Fat-free mass
Tanner stage 1
Pre-pubertal
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 49
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be healthy African-American, Asian (Chinese, Korean, Japanese), and Caucasian pre-pubertal females and males (ages 7-11 years) at baseline. Lean (Body mass index (BMI) \< 85th by age and sex) and obese (BMI \> 95th percentile by age and sex.

Brief summary: Young children have a high resting energy expenditure (REE) relative to their body weight and metabolically active compartment, fat-free mass (FFM). Both body weight and FFM are, however, metabolically heterogeneous and include organs and tissues varying widely in specific metabolic rate (i.e., organ REE/kg/d). One prevailing hypothesis is that most, if not all, of the higher REE observed in young animals and children compared to adults can be accounted for by a larger proportion of high metabolic rate components such as brain, liver, and heart..

Detailed description: FFM was the traditional and only means of adjusting REE for between-individual differences in metabolically active tissue components. The investigators seek to improve the understanding of variation in REE by developing new and improved rapid magnetic resonance imaging (MRI) methods of quantifying some of the major heat producing organs and tissues in children and adults. The long-term aim is to provide an improved understanding of human energy requirements. Specifically, the investigators propose to test whether: 1) a portion of the elevated daily REE adjusted for FFM observed in young children (Tanner Stage 1) could be accounted for by the relative fractions of body mass as high metabolic activity tissues (heart, liver, kidney, brain) and low metabolic activity tissues (skeletal muscle, adipose tissue), 2) a portion of the age-related decline in daily REE adjusted for FFM observed in children could be accounted for by changes in the relative fractions of body mass as high and low metabolic rate tissues during growth.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Aged from 7-11 years
* Pre-pubertal (based on Tanner staging)
* Africa-American, Asian, and Caucasian (by self-report of all 4 grandparents of same race group)

Exclusion Criteria:

* Actively involved in a weight management program
* Have co-morbidities of obesity (Blounts disease, hypertension, diabetes; sleep apnea)
* Have entered puberty
* Precocious puberty
* Have known metabolic abnormalities
* Were born prematurely, or were small or large for gestational age
* Lean individuals who have a family history (parents or siblings) of obesity or Type 2 diabetes
* Current or previous significant use of any medication known to affect any of the variables being measured

Primary outcomes:
measure: Resting energy expenditure in kilocalories
timeFrame: Day 1
measure: Fat mass in kilograms
timeFrame: Day 1
measure: Fat-free mass in kilograms
timeFrame: Day 1
measure: Height in meters
timeFrame: Day 1
measure: Weight in kilograms
timeFrame: Day 1
measure: Liver in kilograms
timeFrame: Day 1
measure: Heart in kilogram
timeFrame: Day 1
measure: Kidneys in kilogram
timeFrame: Day 1
measure: Spleen in kilograms
timeFrame: Day 1
measure: Trunk high metabolic rate organs in kilograms
timeFrame: Day 1
measure: Brain mass in kilogram
timeFrame: Day 1
measure: Skeletal muscle mass in kilograms
timeFrame: Day 1
measure: Residual fat-free mass in kilograms
timeFrame: Day 1
measure: Total body adipose tissue mass in kilogram
timeFrame: Day 1
measure: Body mass index in kg/m2
timeFrame: Day 1
measure: Variability in resting energy expenditure
timeFrame: Day 1
Secondary outcomes:
measure: Change in resting energy expenditure in relation to changes in body composition and organ mass.
timeFrame: From baseline measure to follow-up, approximately 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Dympna Gallagher
state: New York
Study officials:
affiliation: Columbia University
name: Dympna Gallagher
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauer J, Thornton J, Heymsfield S, Kelly K, Ramirez A, Gidwani S, Gallagher D. Dual-energy X-ray absorptiometry prediction of adipose tissue depots in children and adolescents. Pediatr Res. 2012 Oct;72(4):420-5. doi: 10.1038/pr.2012.100. Epub 2012 Jul 20.
citation: Dorsey KB, Thornton JC, Heymsfield SB, Gallagher D. Greater lean tissue and skeletal muscle mass are associated with higher bone mineral content in children. Nutr Metab (Lond). 2010 May 11;7:41. doi: 10.1186/1743-7075-7-41.
citation: Shen W, Velasquez G, Chen J, Jin Y, Heymsfield SB, Gallagher D, Pi-Sunyer FX. Comparison of the relationship between bone marrow adipose tissue and volumetric bone mineral density in children and adults. J Clin Densitom. 2014 Jan-Mar;17(1):163-9. doi: 10.1016/j.jocd.2013.02.009. Epub 2013 Mar 21.
citation: Gao Y, Zong K, Gao Z, Rubin MR, Chen J, Heymsfield SB, Gallagher D, Shen W. Magnetic resonance imaging-measured bone marrow adipose tissue area is inversely related to cortical bone area in children and adolescents aged 5-18 years. J Clin Densitom. 2015 Apr-Jun;18(2):203-8. doi: 10.1016/j.jocd.2015.03.002. Epub 2015 Apr 1.