Examining the Relationship Between Tobacco Exposure, Abdominal Obesity, and Metabolic Syndrome in Adolescents (The STRONG Kids Study) (STRONG Kids)
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| ClinicalTrials.gov Identifier: NCT00808158 |
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Recruitment Status
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Completed
First Posted
: December 15, 2008
Last Update Posted
: November 30, 2012
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| Condition or disease |
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| Metabolic Syndrome |
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.
| Study Type : | Observational |
| Actual Enrollment : | 117 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Metabolic Syndrome in Adolescents: Contribution of Tobacco and Central Fat |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | May 2012 |
| Actual Study Completion Date : | May 2012 |
| Group/Cohort |
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Children ages 9 to 10 years old, with a body mass index (BMI) in the 50th to 98th percentile range
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- Baseline association between tobacco exposure, abdominal obesity, adiponectin, and metabolic syndrome components [ Time Frame: Measured at baseline ]
- Temporal change in abdominal obesity, adiponectin, and metabolic syndrome components, as correlated with level of tobacco exposure [ Time Frame: Measured at Years 1, 2, and 3 ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 9 Years to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808158
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Stephen R. Cook, MD, MPH | University of Rochester |
| Responsible Party: | Stephen Cook, Associate Professor, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00808158 History of Changes |
| Other Study ID Numbers: |
612 R01HL083056-01 ( U.S. NIH Grant/Contract ) HL086946-02 |
| First Posted: | December 15, 2008 Key Record Dates |
| Last Update Posted: | November 30, 2012 |
| Last Verified: | November 2012 |
Additional relevant MeSH terms:
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Syndrome Metabolic Syndrome X Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |