Nctid:
NCT00001522
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-17"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000050177", "term"=>"Overweight"}], "ancestors"=>[{"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M26186", "name"=>"Overweight", "asFound"=>"Overweight", "relevance"=>"HIGH"}, {"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10370", "name"=>"Insulin Resistance", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M10365", "name"=>"Insulin", "relevance"=>"LOW"}, {"id"=>"M173166", "name"=>"Insulin, Globin Zinc", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hypoglycemic Agents", "abbrev"=>"Hypo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>246}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1996-06-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2018-04-12", "completionDateStruct"=>{"date"=>"2018-04-12"}, "lastUpdateSubmitDate"=>"2019-09-20", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2019-09-23", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Adiposity", "timeFrame"=>"Yearly for 15 years"}]}, "conditionsModule"=>{"keywords"=>["Insulin Resistance", "Race", "Body Fat", "Body Composition", "Obesity"], "conditions"=>["Obesity"]}, "referencesModule"=>{"references"=>[{"pmid"=>"9285838", "type"=>"BACKGROUND", "citation"=>"Yanovski SZ, Reynolds JC, Boyle AJ, Yanovski JA. Resting metabolic rate in African-American and Caucasian girls. Obes Res. 1997 Jul;5(4):321-5. doi: 10.1002/j.1550-8528.1997.tb00558.x."}, {"pmid"=>"8393890", "type"=>"BACKGROUND", "citation"=>"Yanovski JA, Yanovski SZ, Gold PW, Chrousos GP. Differences in the hypothalamic-pituitary-adrenal axis of black and white women. J Clin Endocrinol Metab. 1993 Aug;77(2):536-41. doi: 10.1210/jcem.77.2.8393890."}, {"pmid"=>"8422781", "type"=>"BACKGROUND", "citation"=>"Ravussin E. Energy metabolism in obesity. Studies in the Pima Indians. Diabetes Care. 1993 Jan;16(1):232-8. doi: 10.2337/diacare.16.1.232."}, {"pmid"=>"34519823", "type"=>"DERIVED", "citation"=>"Ballenger KL, Tugarinov N, Talvacchio SK, Knue MM, Dang Do AN, Ahlman MA, Reynolds JC, Yanovski JA, Marini JC. Osteogenesis Imperfecta: The Impact of Genotype and Clinical Phenotype on Adiposity and Resting Energy Expenditure. J Clin Endocrinol Metab. 2022 Jan 1;107(1):67-76. doi: 10.1210/clinem/dgab679. Erratum In: J Clin Endocrinol Metab. 2022 Feb 17;107(3):e1335. doi: 10.1210/clinem/dgab770."}, {"pmid"=>"30937899", "type"=>"DERIVED", "citation"=>"Demidowich AP, Parikh VJ, Dedhia N, Branham RE, Madi SA, Marwitz SE, Roberson RB, Uhlman AJ, Levi NJ, Mi SJ, Jun JY, Broadney MM, Brady SM, Yanovski JA. Associations of the melanocortin 3 receptor C17A + G241A haplotype with body composition and inflammation in African-American adults. Ann Hum Genet. 2019 Sep;83(5):355-360. doi: 10.1111/ahg.12315. Epub 2019 Apr 2."}, {"pmid"=>"29718281", "type"=>"DERIVED", "citation"=>"Han JC, Reyes-Capo DP, Liu CY, Reynolds JC, Turkbey E, Turkbey IB, Bryant J, Marshall JD, Naggert JK, Gahl WA, Yanovski JA, Gunay-Aygun M. Comprehensive Endocrine-Metabolic Evaluation of Patients With Alstrom Syndrome Compared With BMI-Matched Controls. J Clin Endocrinol Metab. 2018 Jul 1;103(7):2707-2719. doi: 10.1210/jc.2018-00496."}, {"pmid"=>"26210388", "type"=>"DERIVED", "citation"=>"Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18."}, {"pmid"=>"22234282", "type"=>"DERIVED", "citation"=>"Tanofsky-Kraff M, Shomaker LB, Stern EA, Miller R, Sebring N, Dellavalle D, Yanovski SZ, Hubbard VS, Yanovski JA. Children's binge eating and development of metabolic syndrome. Int J Obes (Lond). 2012 Jul;36(7):956-62. doi: 10.1038/ijo.2011.259. Epub 2012 Jan 10."}, {"pmid"=>"21911779", "type"=>"DERIVED", "citation"=>"Shomaker LB, Tanofsky-Kraff M, Stern EA, Miller R, Zocca JM, Field SE, Yanovski SZ, Hubbard VS, Yanovski JA. Longitudinal study of depressive symptoms and progression of insulin resistance in youth at risk for adult obesity. Diabetes Care. 2011 Nov;34(11):2458-63. doi: 10.2337/dc11-1131. Epub 2011 Sep 12. Erratum In: Diabetes Care. 2020 Dec;43(12):3136. doi: 10.2337/dc20-er12."}]}, "descriptionModule"=>{"briefSummary"=>"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.\n\nResearch 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.\n\nAfrican 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.\n\nThis 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.\n\nPatients participating in this study will be followed for 15 years and be evaluated every 5 years during the study.\\<TAB\\>", "detailedDescription"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"6 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nVolunteers will qualify for inclusion under this protocol if they meet the following criteria:\n\n1. Good general health. Individuals with renal, hepatic, most endocrinologic (e.g. hypothyroidism, or Cushing syndrome), or pulmonary disorders (other than mild asthma not requiring chronic medication) will be excluded.\n2. For obese subjects, body mass index for age above the 85th percentile (determined by NHANES I age-, sex-, and race-special data). For normal weight subjects of obese parents, body mass index (determined by NHANES I age-, sex-, and race- specific data) between the 5th and 85th percentile and both parents' current body mass index above 25 kg/m(2), or a history of a body mass index above 25 kg/m(2).\n3. No significant psychiatric illness.\n4. At initial visit, Tanner I (prepubertal) or Tanner II (early pubertal) pubic hair and breast stage of development for girls, and Tanner I or Tanner II pubic hair and testes size (6ml) for boys.\n5. Subjects must be able to undergo MRI. Volunteers with metal in their bodies that are contraindications for MRI will be excluded. These include cardiac pacemakers, neural pacemakers, aneurysmal clips, shrapnel, ocular foreign bodies, cochlear implants, non-detachable electronic or electromechanical devices (such as infusion pumps, nerve stimulators, bone growth stimulators, etc.).\n6. Age 6 to12 years at the start of the study.\n7. For girls who have been followed to an age when they are menstruating (or are of an age when pregnancy is a possibility), a negative pregnancy test.\n8. Race of all 4 grandparents self-identified either as all Caucasian or all African American."}, "identificationModule"=>{"nctId"=>"NCT00001522", "briefTitle"=>"Metabolic Differences of Overweight Children and Children of Overweight Parents", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Population Differences in the Insulin Sensitivity, Resting Energy Expenditure, and Body Composition of Overweight Children and Children of Overweight Parents", "orgStudyIdInfo"=>{"id"=>"960101"}, "secondaryIdInfos"=>[{"id"=>"96-CH-0101"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institutes of Health Clinical Center, 9000 Rockville Pike", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}], "overallOfficials"=>[{"name"=>"Jack A Yanovski, M.D.", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)", "class"=>"NIH"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
