- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02040740
Mediators of Kidney-Bone Communication in Childhood (PAKC)
Pubertal Assessment of Kidney-Bone Crosstalk
An identified hormone linking bone and kidney function is Fibroblast Growth Factor-23 (FGF23). Data on the variation of FGF23 levels for bone and mineral metabolism in children are scarce. Currently it is assumed that meeting mineral requirements for the skeleton serves the body's overall needs. However, it is not clear as to whether this is true, particularly with growth. The contribution of dietary factors directly linked with the bone/kidney axis through measurement of intake (via 24hr recall) and kidney nutrient clearance (via serum and urinary analysis) will be included in investigations. Findings will serve as a springboard for delineating more specific mechanisms by which these systems become disordered and are influenced by diet. It is expected that adequacy of nutrients known to have a central role in bone function will optimize the hormonal milieu through crosstalk with the kidney.
This effort will allow ongoing investigation in detecting and treating disturbances in mineral metabolism related to kidney disease, specifically in the pediatric population and broaden the understanding of kidney disease itself, as well as that of chronic diseases in which kidney health is of importance, such as diabetes and osteoporosis. Findings of this research may stress the importance of achieving dietary adequacy essential for establishing optimal body composition trajectories, particularly puberty.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama at Birmingham
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Male
- ages 7-11y
- Tanner stage less than or equal to 3 according to the criteria of Marshall and Tanner
Exclusion Criteria:
- History of Cushing's Syndrome, hyperprolactinemia, congenital (non-classic) adrenal hyperplasia, type 1 or 2 diabetes, disturbances in glucose or lipid metabolism
- use of tobacco or consumption of alcohol; thyroid medication, diuretics, beta-blockers, or any medication that potentially could affect body composition, the lipid profile, insulin sensitivity, or blood pressure
- eating disorders, cancer, kidney disease, endocrinopathy, liver disease, heart disease, or thyroid disease.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Observation
Healthy early pubertal boys
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Fibroblast Growth Factor 23
Tidsram: 1 day
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Fasting plasma measure
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1 day
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Krista Casazza, PhD, RD, UAB, Nutrition Sciences
- Studierektor: Orlando M Gutierrez, MD, UAB, Department of Medicine
- Studierektor: Lynae J Hanks, PhD, RD, UAB, Department of Medicine
- Studierektor: Ambika P Ashraf, MD, Children's of Alabama, Pediatric Endocrinology
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- PAKC
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