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NCT01041898 · ClinicalTrials.gov registry record
The Bone-Fat-Pancreas Axis in Children
A clinical trial, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- 28
- Enrollment target
NCT01041898: Completed study, sponsored by University of Alabama at Birmingham.
NCT01041898 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041898 has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
The overarching hypothesis of this proposal is that obesity and positive energy balance in children promote both low bone mass accrual and risk for diabetes through events that are mechanistically associated and that involve bone as an endocrine organ. Recent studies conducted in mice have uncovered the presence of a unique "bone-fat-pancreas" axis that regulates energy homeostasis, coordinates energy partitioning between bone and adipose tissue, and impacts insulin sensitivity. The adipocyte-derived hormone leptin, elevated levels of which reflect both adiposity and positive energy balance, inhibits bone formation via sympathetic activation. Decreased bone formation in turn depresses insulin sensitivity and secretion via decreased production of undercarboxylated osteocalcin (unOC), a novel bone-derived hormone. Although data from mice are compelling, this novel pathway has not been widely tested in humans. Sparse data from adult men and women suggest that this axis is active in humans, and that unOC is regulated in part by exercise. No data are available regarding the bone-fat-pancreas axis in children. Because the foundations of body composition trajectories and metabolic "programming" are established early in the life course, childhood, particularly during early stages of growth and development, is an especially salient time period for evaluating the bone-fat-pancreas axis. With this pilot grant, we propose to gather evidence that these interrelationships exist in children. The data from this project will be used to prepare an NIH R01 proposal to conduct a lifestyle-based intervention in children aimed both at reducing risk for osteoporosis and type 2 diabetes, and at identifying the role of unOC in metabolism and tissue partitioning. Hypothesis 1: Obesity and positive energy balance in children decrease bone mass via elevated leptin. Specific Aim 1: Determine the association between bone mass by DXA and serum leptin concentration in lean and obese children. We
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2009-12 |
| Est. Completion | 2011-12 |
What the finished NCT01041898 record still lists
NCT01041898 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01041898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01041898 about?
NCT01041898 is a clinical study titled "The Bone-Fat-Pancreas Axis in Children". The overarching hypothesis of this proposal is that obesity and positive energy balance in children promote both low bone mass accrual and risk for diabetes through events that are mechanistically associated and that involve bone as an endocrine organ. Recent studies conducted in mice have uncovered...
What is the current status of trial NCT01041898?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2009-12. Estimated completion is 2011-12.
Who is sponsoring clinical trial NCT01041898?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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