- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041794
Tissue Partitioning in Early Childhood
Tissue Partitioning in Early Childhood: A Critical Period for Obesity Risk?
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:
Quantify body composition, adipose tissue distribution, and relative tissue ratios using magnetic resonance imaging (MRI) and dual-energy x-ray absorptiometry (DXA).
- Hypothesis: Early partitioning of 'resources' toward fat mass accrual will lead to decreased gains in bone mass that may persist long-term.
- 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.
- Hypothesis: Children with greater levels of physical activity (energy expenditure) will have greater partitioning towards bone (and lean) mass.
Quantify adipose tissue distribution and adipocyte cell size and number using MRI and histological techniques.
- 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.
- 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 Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- UAB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy
- Aged 3-7 years
- Not taking medications known to affect body composition or metabolism
Exclusion Criteria:
- Not meeting inclusion criteria
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate if early life experiences may induce long term effects on body composition by impacting biological and hormonal axes that regulate childhood body composition.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F091006004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Changes in Bone Mineral Content
-
University of AarhusCompletedChange in Bone Mineral Density | Change in Bone Marrow Fat ContentDenmark
-
Ioannis G. FatourosDemocritus University of ThraceUnknownAthletic Performance | Bone Density | Bone Turnover Markers | Bone Mineral ContentGreece
-
Henry Ford Health SystemCompletedTo Assess the Changes in Markers of Bone Turnover Over a Six Month Period After Epidural Steroid Inject | To Assess the Changes in Bone Mineral DensityUnited States
-
University of California, DavisCompletedEvaluate the Changes in Respiratory Heat Content During One Lung VentilationUnited States
-
Fudan UniversityUnknownBone Mineral Density | Bone Turnover Markers | Image Changes of Lumbar FusionChina
-
Insud PharmaChemo ResearchCompletedContraception | Change in Bone Mineral DensityUnited States, Canada
-
Assaf-Harofeh Medical CenterUnknownBone Mineral Density in Cow's Milk Allergic PatientsIsrael
-
Insud PharmaChemo ResearchActive, not recruitingBone Loss | Change in Bone Mineral DensityUnited States, Poland, Czechia
-
St. Jude Children's Research HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedBone Mineral Density | Bone StrengthUnited States
-
State University of New York - Upstate Medical...Completed