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Resting Energy ExpenditureNCT03219229

Metabolic Effects of Differential Organ Growth Rates

An observational study of Resting Energy Expenditure, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 7 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Resting Energy Expenditure
How many people
49 participants
Where
1 siteUnited States
Study dates
14 Feb 2004to 20 Feb 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Dympna Gallagher

    New York, New York, 10032

Other trials in United States

About this study

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..

Read the detailed 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.

Keywords
Fat-free mass, Tanner stage 1, Pre-pubertal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03219229
Study groupRoleWhat they receive
Prepubertal childrenHealthy 7-11 year old girls and boys.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resting energy expenditure in kilocalories

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

    Measured: Day 1

  2. Fat mass in kilograms

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

    Measured: Day 1

  3. Fat-free mass in kilograms

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

    Measured: Day 1

  4. Height in meters

    Measured using a stadiometer

    Measured: Day 1

  5. Weight in kilograms

    Measured using a calibrated scale

    Measured: Day 1

  6. Liver in kilograms

    Total volume measured by MRI

    Measured: Day 1

  7. Heart in kilogram

    Left ventricular mass measured by cardiac gated MRI

    Measured: Day 1

  8. Kidneys in kilogram

    Total volume measured by MRI

    Measured: Day 1

  9. Spleen in kilograms

    Total volume measured by MRI

    Measured: Day 1

  10. Trunk high metabolic rate organs in kilograms

    The sum of liver, kidneys, spleen, and heart

    Measured: Day 1

  11. Brain mass in kilogram

    Total volume measured by MRI

    Measured: Day 1

  12. Skeletal muscle mass in kilograms

    Skeletal muscle volume measured by MRI

    Measured: Day 1

  13. Residual fat-free mass in kilograms

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

    Measured: Day 1

  14. Total body adipose tissue mass in kilogram

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

    Measured: Day 1

  15. Body mass index in kg/m2

    Weight and height will be combined to report BMI

    Measured: Day 1

  16. 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.

    Measured: Day 1

Secondary outcomes (1)

  1. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2017
  2. Study start14 Feb 2004
  3. Primary completion20 Feb 2007
  4. Study completion20 Feb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03219229
Sponsor's protocol ID
AAAO3053
Status last verified
Jul 2017
First submitted
11 Jul 2017
Last updated
18 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22821057

  • 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.

    PubMed 20459832

  • 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.

    PubMed 23522982

  • 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.

    PubMed 25840474

Questions about this trial

What is this clinical trial studying?

An observational study of Resting Energy Expenditure, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resting energy expenditure in kilocalories (time frame: Day 1). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03219229, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.

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