Metabolic Effects of Differential Organ Growth Rates

NCT03219229 | Completed

• 1 other identifier: AAAO3053
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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..

Conditions

Resting Energy Expenditure

Keywords

Fat-free mass; Tanner stage 1; Pre-pubertal

Outcome Measures

Primary Outcomes (16)

• 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

• Fat mass in kilograms

  Measured from a whole-body dual energy X-ray absorptiometry (DXA) scan

  Day 1

• Fat-free mass in kilograms

  Measured from a whole-body dual energy X-ray absorptiometry (DXA) scan

  Day 1

• Height in meters

  Measured using a stadiometer

  Day 1

• Weight in kilograms

  Measured using a calibrated scale

  Day 1

• Liver in kilograms

  Total volume measured by MRI

  Day 1

• Heart in kilogram

  Left ventricular mass measured by cardiac gated MRI

  Day 1

• Kidneys in kilogram

  Total volume measured by MRI

  Day 1

• Spleen in kilograms

  Total volume measured by MRI

  Day 1

• Trunk high metabolic rate organs in kilograms

  The sum of liver, kidneys, spleen, and heart

  Day 1

• Brain mass in kilogram

  Total volume measured by MRI

  Day 1

• Skeletal muscle mass in kilograms

  Skeletal muscle volume measured by MRI

  Day 1

• Residual fat-free mass in kilograms

  Fat-free mass minus the sum of kidneys, liver, spleen, heart, and skeletal muscle

  Day 1

• Total body adipose tissue mass in kilogram

  Represents the sum of visceral, subcutaneous, and intermuscular adipose tissue by MRI

  Day 1

• Body mass index in kg/m2

  Weight and height will be combined to report BMI

  Day 1

• 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 Outcomes (1)

• Change in resting energy expenditure in relation to changes in body composition and organ mass.

  From baseline measure to follow-up, approximately 2 years

Study Arms (1)

Prepubertal children

Healthy 7-11 year old girls and boys.

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Dympna Gallagher

New York, New York, 10032, United States

Location

Related 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.

  PMID: 22821057 RESULT

• 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.

  PMID: 20459832 RESULT

• 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.

  PMID: 23522982 RESULT

• 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.

  PMID: 25840474 RESULT

Study Officials

• Dympna Gallagher

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nutritional Medicine

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 17, 2017
• Study Start: February 14, 2004
• Primary Completion: February 20, 2007
• Study Completion: February 20, 2007
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)