- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00374361
Study of the Relationship Between Blood Vessels and Insulin Response in Adolescents
Relationship of Endothelial Function to Insulin Sensitivity in African American and Caucasian Adolescents
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Purpose: The purpose of the research is to learn more about how the lining of arteries in the body (called the endothelium) and insulin work in adolescents. Abnormalities in how the blood vessels and insulin work in adolescents may cause high blood pressure, type 2 diabetes, stroke and heart disease.
Healthy adolescents between 8 and 18 years of age are being studied in the Ohio State University General Clinical Research Center. Two visits will be necessary. One will be a screening visit to determine the child's stage of puberty and obtain a medical history. The second will be the study visit. During the latter, blood vessel function will be determined by studying the change in forearm blood flow before and after blood flow to the forearm is stopped. Insulin sensitivity will be determined using glucose water given into a vein.
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Caucasian or African American adolescent
- Between 8 and 18 years of age
Exclusion Criteria:
- Pregnancy
- Chronic Disease
- Acute Disease
- Medication Requirement
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Caucasian Adolescents
|
African-American Adolescents
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Robert P Hoffman, MD, Ohio State University
Publikationer og nyttige links
Generelle publikationer
- Hoffman RP. Indices of insulin action calculated from fasting glucose and insulin reflect hepatic, not peripheral, insulin sensitivity in African-American and Caucasian adolescents. Pediatr Diabetes. 2008 Jun;9(3 Pt 2):57-61. doi: 10.1111/j.1399-5448.2007.00350.x. Epub 2008 Jan 21.
- Duck MM, Hoffman RP. Impaired endothelial function in healthy African-American adolescents compared with Caucasians. J Pediatr. 2007 Apr;150(4):400-6. doi: 10.1016/j.jpeds.2006.12.034.
- Hoffman RP. Increased fasting triglyceride levels are associated with hepatic insulin resistance in Caucasian but not African-American adolescents. Diabetes Care. 2006 Jun;29(6):1402-4. doi: 10.2337/dc06-2460. No abstract available.
- Xie L, Hoffman RP, Veng-Pedersen P. Noncompartmental pharmacokinetics analysis of glucose-stimulated insulin response in African-American and Caucasian youths. Biopharm Drug Dispos. 2009 Apr;30(3):117-25. doi: 10.1002/bdd.652.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ENDO 203
- AHA 0355195B (Andet bevillings-/finansieringsnummer: American Heart Association)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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