Metabolic Effects of Differential Organ Growth Rates

Resting Energy Expenditure Clinical Trial

Official title:

Metabolic Effects of Differential Organ Growth Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219229
• Other study ID #: AAAO3053
• Status: Completed
• Phase: N/A
• First received: July 11, 2017
• Last updated: July 14, 2017
• Start date: February 14, 2004
• Est. completion date: February 20, 2007

Study information

• Verified date: July 2017
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 20, 2007
• Est. primary completion date: February 20, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Resting Energy Expenditure

Locations

Country	Name	City	State
United States	Dympna Gallagher	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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 A — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting energy expenditure in kilocalories	REE is measured by indirect calorimetry over a 30 minute period and extrapolated to a 24 hour period	Day 1
Primary	Fat mass in kilograms	Measured from a whole-body dual energy X-ray absorptiometry (DXA) scan	Day 1
Primary	Fat-free mass in kilograms	Measured from a whole-body dual energy X-ray absorptiometry (DXA) scan	Day 1
Primary	Height in meters	Measured using a stadiometer	Day 1
Primary	Weight in kilograms	Measured using a calibrated scale	Day 1
Primary	Liver in kilograms	Total volume measured by MRI	Day 1
Primary	Heart in kilogram	Left ventricular mass measured by cardiac gated MRI	Day 1
Primary	Kidneys in kilogram	Total volume measured by MRI	Day 1
Primary	Spleen in kilograms	Total volume measured by MRI	Day 1
Primary	Trunk high metabolic rate organs in kilograms	The sum of liver, kidneys, spleen, and heart	Day 1
Primary	Brain mass in kilogram	Total volume measured by MRI	Day 1
Primary	Skeletal muscle mass in kilograms	Skeletal muscle volume measured by MRI	Day 1
Primary	Residual fat-free mass in kilograms	Fat-free mass minus the sum of kidneys, liver, spleen, heart, and skeletal muscle	Day 1
Primary	Total body adipose tissue mass in kilogram	Represents the sum of visceral, subcutaneous, and intermuscular adipose tissue by MRI	Day 1
Primary	Body mass index in kg/m2	Weight and height will be combined to report BMI	Day 1
Primary	Variability in resting energy expenditure	The collected measures will be aggregated to statistically test the following question: How much of the variability in resting energy expenditure can be accounted for by the mass of the measured organs (liver, kidneys, spleen, heart) and tissues (fat, skeletal muscle, brain) and is the explained variance greater than the variance explained when predicting resting energy explained from a model using fat and fat-free mass alone.	Day 1
Secondary	Change in resting energy expenditure in relation to changes in body composition and organ mass.	A portion of age-related decline (2-years) in daily REE adjusted for FFM observed in children is explainable in part by changes in the relative fractions of body mass as high (brain, heart, liver, kidney) and low (skeletal muscle, adipose tissue) metabolic activity tissues with growth and pubertal progress	From baseline measure to follow-up, approximately 2 years