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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03219229
Other study ID # AAAO3053
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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