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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 is a clinical trial that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 28 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01041898
The ClinicalTrials.gov registry entry for NCT01041898 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01041898 reports 0 study locations.
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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