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

NCT00808158 | Completed DMC

• 3 other identifiers: 612R01HL083056-01HL086946-02
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components

  Measured at baseline

Secondary Outcomes (1)

• Temporal change in abdominal obesity, adiponectin, and metabolic syndrome components, as correlated with level of tobacco exposure

  Measured at Years 1, 2, and 3

Study Arms (1)

1

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

Eligibility Criteria

• Age: 9 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• BMI in the 50th to 98th percentile range
• Parent or caregiver must agree to participate in the study

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, whole blood, white blood cells, saliva, urine

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stephen R. Cook, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-11

Locations

US (1)