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Completed

NCT Number: NCT03219229

Metabolic Effects of Differential Organ Growth Rates

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..

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dympna Gallagher

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Resting energy expenditure in kilocalories

    Time frame: Day 1

    REE is measured by indirect calorimetry over a 30 minute period and extrapolated to a 24 hour period

  2. Fat mass in kilograms

    Time frame: Day 1

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

  3. Fat-free mass in kilograms

    Time frame: Day 1

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

  4. Height in meters

    Time frame: Day 1

    Measured using a stadiometer

  5. Weight in kilograms

    Time frame: Day 1

    Measured using a calibrated scale

  6. Liver in kilograms

    Time frame: Day 1

    Total volume measured by MRI

  7. Heart in kilogram

    Time frame: Day 1

    Left ventricular mass measured by cardiac gated MRI

  8. Kidneys in kilogram

    Time frame: Day 1

    Total volume measured by MRI

  9. Spleen in kilograms

    Time frame: Day 1

    Total volume measured by MRI

  10. Trunk high metabolic rate organs in kilograms

    Time frame: Day 1

    The sum of liver, kidneys, spleen, and heart

  11. Brain mass in kilogram

    Time frame: Day 1

    Total volume measured by MRI

  12. Skeletal muscle mass in kilograms

    Time frame: Day 1

    Skeletal muscle volume measured by MRI

  13. Residual fat-free mass in kilograms

    Time frame: Day 1

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

  14. Total body adipose tissue mass in kilogram

    Time frame: Day 1

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

  15. Body mass index in kg/m2

    Time frame: Day 1

    Weight and height will be combined to report BMI

  16. Variability in resting energy expenditure

    Time frame: Day 1

    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.

Secondary outcomes

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

    Time frame: From baseline measure to follow-up, approximately 2 years

    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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 17, 2017
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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