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Completed No phase listed Observational Accepts healthy volunteers

Tissue Partitioning in Early Childhood

ClinicalTrials.gov ID: NCT01041794

Public ClinicalTrials.gov record NCT01041794. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 14, 2026, 3:28 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Tissue Partitioning in Early Childhood: A Critical Period for Obesity Risk?

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Early childhood (\~4-6 years of age) is an important window for determining body composition trajectory and may be a critical period for the development of tissue partitioning patterns that influence later disease risk, including obesity and type 2 diabetes. As adiposity accelerates during this critical period, deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of tissue mass accrued in early childhood has implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting energy expenditure. The interplay between fat and bone deposition represents a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly the phenotype underlying obesity and diabetes risk may be determined by the differentiation of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development. In vitro studies demonstrate transdifferentiation under the influence of specific external stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass accrual in adulthood, even when the stimulus is later removed (animals are no longer exercising). Children's early experiences (engagement in physical activity) may 'environmentally induce' alterations in body composition and predispose individuals to diabetes throughout life (Figure 1). Hypotheses and Specific Aims: Early growth patterns and cell differentiation may induce long term effects on body composition by impacting biological and hormonal axes that regulate childhood body composition. Body composition comprises not only absolute mass, but also aspects of size, shape and location. To that end, the following specific aims will be evaluated: 1. Quantify body composition, adipose tissue distribution, and relative tissue ratios using magnetic resonance imaging (MRI) and dual-energy x-ray absorptiometry (DXA). 1. Hypothesis: Early partitioning of 'resources' toward fat mass accrual will lead to decreased gains in bone mass that may persist long-term. 2. Hypothesis: Partitioning of tissue toward fat at the expense of bone mass (and indirectly, lean mass) will result in adverse effects on glucose/insulin metabolism, total energy expenditure, resting metabolic rate and hormone signaling. 3. Hypothesis: Children with greater levels of physical activity (energy expenditure) will have greater partitioning towards bone (and lean) mass. 2. Quantify adipose tissue distribution and adipocyte cell size and number using MRI and histological techniques. 1. Hypothesis: A relatively greater amount of bone marrow adipose tissue will be apparent in those children with low levels of physical activity, resulting in the preferential differentiation of pluripotent stem cells towards adipocytes vs osteocytes in the bone marrow cavity. 2. A relatively greater adipocyte cell number will be apparent in those children with low levels of physical activity indicating greater differentiation of MSC towards adipocytes vs osteocytes.

Study identification

NCT ID
NCT01041794
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
24 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Years to 7 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2009
Primary completion
Nov 30, 2010
Completion
May 31, 2011
Last update posted
Nov 24, 2019

2009 – 2011

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
UAB Birmingham Alabama 35294

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01041794, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 24, 2019 · Synced Sep 14, 2026

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