Resting Energy Expenditure Clinical Trial
Official title:
Metabolic Effects of Differential Organ Growth Rates
Verified date | July 2017 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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..
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 |
Country | Name | City | State |
---|---|---|---|
United States | Dympna Gallagher | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
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
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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