- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00808158
Examining the Relationship Between Tobacco Exposure, Abdominal Obesity, and Metabolic Syndrome in Adolescents (The STRONG Kids Study) (STRONG Kids)
Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Metabolic syndrome is a term that is used to describe a group of risk factors for cardiovascular disease. The risk factors include obesity, insulin resistance, high cholesterol, and high blood pressure. Two of the most common risk factors for cardiovascular disease-tobacco exposure and abdominal obesity-are also known to influence the development of metabolic syndrome. Metabolic syndrome risk factors, as well as higher obesity levels, are being observed increasingly in adolescents. It is important to understand the relationship between tobacco exposure, abdominal obesity, and metabolic syndrome during early adolescence, as this time period is when lifestyle habits, including diet, exercise, and tobacco use, develop. The purpose of the study is to determine how changes in abdominal obesity and tobacco exposure among adolescents affect the development of metabolic syndrome risk factors, including glucose intolerance and increased levels of cholesterol and blood pressure.
This 3-year study will enroll children with a body mass index in the 50th to 98th percentile and one of their parents. At a baseline study visit, children and parents will complete questionnaires on health, nutrition, physical activity, smoke exposure, and stress levels. Children will undergo a blood and saliva collection; physical examination; measurements of blood pressure, height, weight, and waist circumference; a dual-energy x-ray absorptiometry (DEXA) scan to measure body fat and muscle; and skin fold measurements to measure body fat. Parents will undergo a saliva collection and measurements of blood pressure, height, weight, and waist circumference. Some children will wear an activity monitor for 7 days, and some children will complete a glucose tolerance test, which will involve an additional blood collection. Every 6 months, study researchers will contact parents to confirm the family's contact information. Once a year for 3 years, all participants will complete questionnaires and a saliva collection. Additionally, at Year 3, all participants will also undergo repeat measurements of blood pressure, height, weight, and waist circumference.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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New York
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Rochester, New York, Forente stater, 14642
- University of Rochester
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- BMI in the 50th to 98th percentile range
- Parent or caregiver must agree to participate in the study
Exclusion Criteria for All Participants:
- Inability to speak and understand English
- Family residence outside the greater Rochester area (more than 50 miles from the clinical research center)
- Family is planning to leave the greater Rochester area (move more than 50 miles from the clinical research center) in the 24 months after study entry
Exclusion Criteria for Children:
- Significant medical condition, including cystic fibrosis, type 1 or type 2 diabetes, or other conditions that could interfere with the assessment of metabolic-related outcome measures
- Tanner stage 3 or greater
- Currently taking medications that alter appetite and/or glucose metabolism
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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1
Children ages 9 to 10 years old, with a body mass index (BMI) in the 50th to 98th percentile range
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components
Tidsramme: Measured at baseline
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Measured at baseline
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Temporal change in abdominal obesity, adiponectin, and metabolic syndrome components, as correlated with level of tobacco exposure
Tidsramme: Measured at Years 1, 2, and 3
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Measured at Years 1, 2, and 3
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Stephen R. Cook, MD, MPH, University of Rochester
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 612
- R01HL083056-01 (U.S. NIH-stipend/kontrakt)
- HL086946-02
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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