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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | June 1996 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00001522 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Metabolic Differences of Overweight Children and Children of Overweight Parents | ||||||||
| Official Title ICMJE | Population Differences in the Insulin Sensitivity, Resting Energy Expenditure, and Body Composition of Overweight Children and Children of Overweight Parents | ||||||||
| Brief Summary | This study focuses on the way weight is gained. Individuals who gain weight primarily in their midsection (visceral weight) are at an increased risk for developing diabetes and high blood pressure. Research has shown that African Americans suffer more often from high blood pressure, diabetes (non-insulin dependent), and heart disease than Caucasian Americans. These conditions lead to significant numbers of deaths and diseases associated with and made worse by obesity. African American women in particular suffer from obesity and the associated conditions of obesity more than any other race or gender. However, it is unknown if the conditions seen in African American women are a result of the obesity or differences in their insulin sensitivity, glucose disposal, or fat metabolism. This study will compare body composition, total and resting energy expenditure, and glucose disposal of obese African American and Caucasian children and of non-obese children of obese African American and Caucasian parents, to characterize the timing and nature of factors that may contribute to the prevalence of obesity and its complications. Patients participating in this study will be followed for 15 years and be evaluated every 5 years during the study. |
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| Detailed Description | African Americans have a greater prevalence than Caucasian Americans of hypertension, non-insulin-dependent diabetes mellitus, and cardiovascular disease. These conditions lead to substantial excess morbidity and mortality and are associated with and exacerbated by obesity, the prevalence of which is strikingly elevated in African American women. It is unknown if this increased prevalence of comorbid conditions is solely related to the greater prevalence of severe obesity among African American women, or due to differences in insulin sensitivity, glucose disposal, body composition, or fat cell metabolism. Through this project, we have verified that many of the physiological differences observed between African American and Caucasian adults are already present in obese children and in children at high risk for developing obesity. However, the roles that differences in energy expenditure, glucose metabolism, body composition, and other factors play in determining which children develop obesity and its comorbid conditions in adulthood remain unclear. In this study, we compare body composition, total and resting energy expenditure, and glucose disposal of obese African American and Caucasian children and of non-obese children of obese African American and Caucasian parents, to characterize the timing and nature of factors that may contribute to the prevalence of obesity and its complications. We also relate serum levels of the body-fat related circulating factors such as leptin, to these measures, and obtain samples for genomic DNA isolation from participants and their parents to characterize the roles of genes felt important for the development of obesity. We will follow these children for 15 years, studying them intensively at 5 year intervals until adulthood. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 350 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Volunteers will qualify for inclusion under this protocol if they meet the following criteria:
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| Gender | Both | ||||||||
| Ages | 6 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001522 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 960101, 96-CH-0101 | ||||||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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