- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01798030
Vitamin D Retrospective Study and Role With Disease
Association of Vitamin D With Diabetes, Osteoporosis and Cardiovascular Risk
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
The heightened prevalence of obesity in aging especially in postmenopausal women suggests that interventions to raise Vitamin D levels might be preventive of these diseases. Investigators have completed studies of the effects of weight loss and exercise interventions in approximately 400 older women and men over the last 15 years, many of whom are obese. Investigators have data on glucose tolerance, blood pressure and bone density in these studies and stored plasma in which investigators can analyze Vitamin D levels. Vitamin D may be an important risk factor for these metabolic diseases and the availability of these samples for Vitamin D analysis will allow investigators to perform a cross-sectional study to address relationships of Vitamin D levels to glucose intolerance and diabetes, hypertension/blood pressure status, bone mineral density, the degree of obesity, and physical activity status measured as maximal aerobic capacity and accelerometry in these older men and women.
The results of this study have the potential to impact clinical practice in the prevention and treatment of diabetes, hypertension, and osteopenia/osteoporosis. This would circumvent the current dilemma for prevention of these chronic diseases through treatment of obesity, as these data would provide immediate prospects for changing the recommended doses of Vitamin D beneficial for reducing risk for these diseases.
The purpose of this study is to 1) determine the prevalence of Vitamin D deficiency in obese, older men and postmenopausal women and 2) the association of Vitamin D levels to glucose tolerance, blood pressure, bone mineral density, and hyperlipidemia, as well as association with Vitamin D receptor gene polymorphisms affecting metabolic responses to Vitamin D.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- Baltimore VAMC
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria: 45-85 years of age
Exclusion Criteria: none
-
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Vitamin D
Specimen analysis
|
N/A, frozen specimen study
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Vitamin D
Tidsramme: Day 1
|
Vitamin D level ng/dl
|
Day 1
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
IGF-1
Tidsramme: Day 1
|
Insulin like growth factor
|
Day 1
|
|
IGF binding proteins
Tidsramme: Day 1
|
Insulin Growth Factor Binding protein levels
|
Day 1
|
|
PTH
Tidsramme: Day 1
|
Parathyroid Hormone levels
|
Day 1
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Alice S Ryan, PhD, Baltimore VAMC
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 43973
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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