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Examining the Relationship Between Tobacco Exposure, Abdominal Obesity, and Metabolic Syndrome in Adolescents (The STRONG Kids Study) (STRONG Kids)

29. november 2012 opdateret af: Stephen Cook, University of Rochester

Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat

Metabolic syndrome is a term that describes a group of conditions that increase the risk of cardiovascular disease. The conditions include high blood pressure, obesity, and high cholesterol. This study will examine how changes in tobacco exposure and weight can affect the risk of developing metabolic syndrome among adolescents.

Studieoversigt

Status

Afsluttet

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

Observationel

Tilmelding (Faktiske)

117

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 10 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

A community sample of 240 9- to 10-year olds with varying abdominal obesity levels (all having a waist circumference equal to or above the 50th percentile for age and gender) and varying tobacco smoke exposure levels (from none to high levels)

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
1
Children ages 9 to 10 years old, with a body mass index (BMI) in the 50th to 98th percentile range

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components
Tidsramme: Measured at baseline
Measured at baseline

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
Measured at Years 1, 2, and 3

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Stephen R. Cook, MD, MPH, University of Rochester

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2008

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. maj 2012

Datoer for studieregistrering

Først indsendt

12. december 2008

Først indsendt, der opfyldte QC-kriterier

12. december 2008

Først opslået (Skøn)

15. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 612
  • R01HL083056-01 (U.S. NIH-bevilling/kontrakt)
  • HL086946-02

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Metabolisk syndrom

3
Abonner