- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester
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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:
- 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 undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
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 |
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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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Stephen R. Cook, MD, MPH, University of Rochester
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 612
- R01HL083056-01 (U.S. NIH-bevilling/kontrakt)
- HL086946-02
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