Nctid:
NCT00001723
Payload:
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"organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE_4.03"}, {"term"=>"epistaxis", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>100, "numAffected"=>5}, {"groupId"=>"EG001", "numAtRisk"=>100, "numAffected"=>2}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE_4.03"}, {"term"=>"feeling cold", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>100, "numAffected"=>5}, {"groupId"=>"EG001", "numAtRisk"=>100, "numAffected"=>2}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE_4.03"}, {"term"=>"headache", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>100, "numAffected"=>14}, {"groupId"=>"EG001", "numAtRisk"=>100, "numAffected"=>17}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE_4.03"}, {"term"=>"increased sweating", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>100, "numAffected"=>3}, {"groupId"=>"EG001", "numAtRisk"=>100, "numAffected"=>4}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE_4.03"}, {"term"=>"increased thirst", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>100, "numAffected"=>5}, {"groupId"=>"EG001", "numAtRisk"=>100, "numAffected"=>4}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE_4.03"}, {"term"=>"sinusitis, post-nasal drip or nasal stuffiness", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>100, "numAffected"=>2}, {"groupId"=>"EG001", "numAtRisk"=>100, "numAffected"=>5}], "organSystem"=>"General disorders", "assessmentType"=>"SYSTEMATIC_ASSESSMENT", "sourceVocabulary"=>"CTCAE_4.03"}, {"term"=>"unusual tiredness or weakness (fatigue)", "stats"=>[{"groupId"=>"EG000", "numAtRisk"=>100, "numAffected"=>1}, {"groupId"=>"EG001", "numAtRisk"=>100, "numAffected"=>5}], "organSystem"=>"General disorders", 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Subjects return for monthly visits for 3 more months."}, {"id"=>"OG001", "title"=>"Placebo", "description"=>"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program\n\nPlacebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"-2.9", "spread"=>"0.7", "groupId"=>"OG000"}, {"value"=>"-0.6", "spread"=>"0.7", "groupId"=>"OG001"}]}]}], "paramType"=>"MEAN", "timeFrame"=>"baseline to 6 months", "description"=>"Weight in kg", "unitOfMeasure"=>"kg", "dispersionType"=>"Standard Error", "reportingStatus"=>"POSTED", "populationDescription"=>"Multiple imputation analysis"}, {"type"=>"SECONDARY", "title"=>"Change in Body Mass Index", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"100", "groupId"=>"OG000"}, {"value"=>"100", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"Orlistat", "description"=>"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program\n\nOrlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}, {"id"=>"OG001", "title"=>"Placebo", "description"=>"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program\n\nPlacebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"-1.44", "spread"=>"0.26", "groupId"=>"OG000"}, {"value"=>"-0.50", "spread"=>"0.20", "groupId"=>"OG001"}]}]}], "paramType"=>"MEAN", "timeFrame"=>"baseline to 6 months", "description"=>"BMI is calculated in kg/m2. Change from baseline to 6 months of treatment", "unitOfMeasure"=>"kg per square meter", "dispersionType"=>"Standard Error", "reportingStatus"=>"POSTED", "populationDescription"=>"Muliple imputation analysis"}, {"type"=>"SECONDARY", "title"=>"Change in Body Fat (kg)", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"100", "groupId"=>"OG000"}, {"value"=>"100", "groupId"=>"OG001"}]}], "groups"=>[{"id"=>"OG000", "title"=>"Orlistat", "description"=>"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program\n\nOrlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}, {"id"=>"OG001", "title"=>"Placebo", "description"=>"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program\n\nPlacebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"-3.2", "spread"=>"0.55", "groupId"=>"OG000"}, {"value"=>"-1.7", "spread"=>"0.53", "groupId"=>"OG001"}]}]}], "paramType"=>"MEAN", "timeFrame"=>"baseline to 6 months", "description"=>"body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)", "unitOfMeasure"=>"kg", "dispersionType"=>"Standard Error", "reportingStatus"=>"POSTED", "populationDescription"=>"Multiple Imputation analysis"}, {"type"=>"SECONDARY", "title"=>"Effect of Race on Change in Weight (kg)", "denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"63", "groupId"=>"OG000"}, {"value"=>"37", "groupId"=>"OG001"}, {"value"=>"60", "groupId"=>"OG002"}, {"value"=>"40", "groupId"=>"OG003"}]}], "groups"=>[{"id"=>"OG000", "title"=>"Orlistat - Non-Hispanic Blacks", "description"=>"Change in weight for Non-Hispanic Black participants treated with orlistat"}, {"id"=>"OG001", "title"=>"Orlistat - Non- Hispanic Whites", "description"=>"Change in weight for Non-Hispanic White participants treated with orlistat"}, {"id"=>"OG002", "title"=>"Placebo - Non-Hispanic Blacks", "description"=>"Change in weight for Non-Hispanic Black participants treated with placebo"}, {"id"=>"OG003", "title"=>"Placebo - Non-Hispanic Whites", "description"=>"Change in weight for Non-Hispanic White participants treated with placebo"}], "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"-2.126", "spread"=>"0.812", "groupId"=>"OG000"}, {"value"=>"-3.742", "spread"=>"1.046", "groupId"=>"OG001"}, {"value"=>"0.415", "spread"=>"0.835", "groupId"=>"OG002"}, {"value"=>"-1.580", "spread"=>"1.013", "groupId"=>"OG003"}]}]}], "paramType"=>"MEAN", "timeFrame"=>"baseline to 6 months", "description"=>"Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)", "unitOfMeasure"=>"kg", "dispersionType"=>"Standard Error", "reportingStatus"=>"POSTED", "populationDescription"=>"Multiple imputation analysis"}]}, "participantFlowModule"=>{"groups"=>[{"id"=>"FG000", "title"=>"Orlistat", "description"=>"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program\n\nOrlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}, {"id"=>"FG001", "title"=>"Placebo", "description"=>"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program\n\nPlacebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}], "periods"=>[{"title"=>"Overall Study", "milestones"=>[{"type"=>"STARTED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"100"}, {"groupId"=>"FG001", "numSubjects"=>"100"}]}, {"type"=>"COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"87"}, {"groupId"=>"FG001", "numSubjects"=>"84"}]}, {"type"=>"NOT COMPLETED", "achievements"=>[{"groupId"=>"FG000", "numSubjects"=>"13"}, {"groupId"=>"FG001", "numSubjects"=>"16"}]}], "dropWithdraws"=>[{"type"=>"Lack of Efficacy", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"6"}, {"groupId"=>"FG001", "numSubjects"=>"7"}]}, {"type"=>"Lack of family interest", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"4"}, {"groupId"=>"FG001", "numSubjects"=>"5"}]}, {"type"=>"Lost to Follow-up", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"2"}, {"groupId"=>"FG001", "numSubjects"=>"2"}]}, {"type"=>"medication intolerance", "reasons"=>[{"groupId"=>"FG000", "numSubjects"=>"1"}, {"groupId"=>"FG001", "numSubjects"=>"2"}]}]}], "recruitmentDetails"=>"Accrual for RCT began in 1999 and ended in 2008. All subjects were screened at the NIH Clinical Center.", "preAssignmentDetails"=>"Most subjects screened but not enrolled (101) did not have an obesity-related comorbid condition (i.e., hypertension or dyslipidemia). 16 met a medical exclusion, and 13 declined participation after undergoing initial evaluation."}, "baselineCharacteristicsModule"=>{"denoms"=>[{"units"=>"Participants", "counts"=>[{"value"=>"100", "groupId"=>"BG000"}, {"value"=>"100", "groupId"=>"BG001"}, {"value"=>"200", "groupId"=>"BG002"}]}], "groups"=>[{"id"=>"BG000", "title"=>"Orlistat", "description"=>"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program\n\nOrlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}, {"id"=>"BG001", "title"=>"Placebo", "description"=>"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program\n\nPlacebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."}, {"id"=>"BG002", "title"=>"Total", "description"=>"Total of all reporting groups"}], "measures"=>[{"title"=>"Age, Categorical", "classes"=>[{"categories"=>[{"title"=>"<=18 years", "measurements"=>[{"value"=>"100", "groupId"=>"BG000"}, {"value"=>"100", "groupId"=>"BG001"}, {"value"=>"200", "groupId"=>"BG002"}]}, {"title"=>"Between 18 and 65 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}]}, {"title"=>">=65 years", "measurements"=>[{"value"=>"0", "groupId"=>"BG000"}, {"value"=>"0", "groupId"=>"BG001"}, {"value"=>"0", "groupId"=>"BG002"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Age Continuous", "classes"=>[{"categories"=>[{"measurements"=>[{"value"=>"14.65", "spread"=>"1.38", "groupId"=>"BG000"}, {"value"=>"14.52", "spread"=>"1.46", "groupId"=>"BG001"}, {"value"=>"14.59", "spread"=>"1.41", "groupId"=>"BG002"}]}]}], "paramType"=>"MEAN", "unitOfMeasure"=>"years", "dispersionType"=>"STANDARD_DEVIATION"}, {"title"=>"Sex: Female, Male", "classes"=>[{"categories"=>[{"title"=>"Female", "measurements"=>[{"value"=>"65", "groupId"=>"BG000"}, {"value"=>"66", "groupId"=>"BG001"}, {"value"=>"131", "groupId"=>"BG002"}]}, {"title"=>"Male", "measurements"=>[{"value"=>"35", "groupId"=>"BG000"}, {"value"=>"34", "groupId"=>"BG001"}, {"value"=>"69", "groupId"=>"BG002"}]}]}], "paramType"=>"COUNT_OF_PARTICIPANTS", "unitOfMeasure"=>"Participants"}, {"title"=>"Region of Enrollment", "classes"=>[{"title"=>"United States", "categories"=>[{"measurements"=>[{"value"=>"100", "groupId"=>"BG000"}, {"value"=>"100", "groupId"=>"BG001"}, {"value"=>"200", "groupId"=>"BG002"}]}]}], "paramType"=>"NUMBER", "unitOfMeasure"=>"participants"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2012-11", "completionDateStruct"=>{"date"=>"2011-10", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2012-11-15", "studyFirstSubmitDate"=>"1999-11-03", "resultsFirstSubmitDate"=>"2012-10-11", "studyFirstSubmitQcDate"=>"1999-11-03", "lastUpdatePostDateStruct"=>{"date"=>"2012-12-18", "type"=>"ESTIMATED"}, "resultsFirstSubmitQcDate"=>"2012-11-15", "studyFirstPostDateStruct"=>{"date"=>"1999-11-04", "type"=>"ESTIMATED"}, "resultsFirstPostDateStruct"=>{"date"=>"2012-12-18", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2011-10", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in BMI Standard Deviation Score", "timeFrame"=>"baseline to 6 months", "description"=>"Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190."}], "secondaryOutcomes"=>[{"measure"=>"Change in Body Weight", "timeFrame"=>"baseline to 6 months", "description"=>"Weight in kg"}, {"measure"=>"Change in Body Mass Index", "timeFrame"=>"baseline to 6 months", "description"=>"BMI is calculated in kg/m2. Change from baseline to 6 months of treatment"}, {"measure"=>"Change in Body Fat (kg)", "timeFrame"=>"baseline to 6 months", "description"=>"body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)"}, {"measure"=>"Effect of Race on Change in Weight (kg)", "timeFrame"=>"baseline to 6 months", "description"=>"Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)"}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"keywords"=>["Dyslipidemia", "Race", "Body Fat", "Visceral Fat", "Sleep Apnea", "Fat-Soluble Vitamins", "Type 2 Diabetes", "Obesity", "Childhood Obesity"], "conditions"=>["Diabetes Mellitus", "Hypertension", "Metabolic Disease", "Obesity", "Sleep Apnea Syndrome"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8022039", "type"=>"BACKGROUND", "citation"=>"Kuczmarski RJ, Flegal KM, Campbell SM, Johnson CL. Increasing prevalence of overweight among US adults. The National Health and Nutrition Examination Surveys, 1960 to 1991. JAMA. 1994 Jul 20;272(3):205-11. doi: 10.1001/jama.272.3.205."}, {"pmid"=>"7627244", "type"=>"BACKGROUND", "citation"=>"Drent ML, Larsson I, William-Olsson T, Quaade F, Czubayko F, von Bergmann K, Strobel W, Sjostrom L, van der Veen EA. Orlistat (Ro 18-0647), a lipase inhibitor, in the treatment of human obesity: a multiple dose study. Int J Obes Relat Metab Disord. 1995 Apr;19(4):221-6."}, {"pmid"=>"1406836", "type"=>"BACKGROUND", "citation"=>"Must A, Jacques PF, Dallal GE, Bajema CJ, Dietz WH. Long-term morbidity and mortality of overweight adolescents. A follow-up of the Harvard Growth Study of 1922 to 1935. N Engl J Med. 1992 Nov 5;327(19):1350-5. doi: 10.1056/NEJM199211053271904."}, {"pmid"=>"15956632", "type"=>"BACKGROUND", "citation"=>"Chanoine JP, Hampl S, Jensen C, Boldrin M, Hauptman J. Effect of orlistat on weight and body composition in obese adolescents: a randomized controlled trial. JAMA. 2005 Jun 15;293(23):2873-83. doi: 10.1001/jama.293.23.2873. Erratum In: JAMA. 2005 Sep 28;294(12):1491."}, {"pmid"=>"15112907", "type"=>"RESULT", "citation"=>"McDuffie JR, Calis KA, Uwaifo GI, Sebring NG, Fallon EM, Frazer TE, Van Hubbard S, Yanovski JA. Efficacy of orlistat as an adjunct to behavioral treatment in overweight African American and Caucasian adolescents with obesity-related co-morbid conditions. J Pediatr Endocrinol Metab. 2004 Mar;17(3):307-19. doi: 10.1515/jpem.2004.17.3.307."}, {"pmid"=>"12126214", "type"=>"RESULT", "citation"=>"McDuffie JR, Calis KA, Booth SL, Uwaifo GI, Yanovski JA. Effects of orlistat on fat-soluble vitamins in obese adolescents. Pharmacotherapy. 2002 Jul;22(7):814-22. doi: 10.1592/phco.22.11.814.33627."}, {"pmid"=>"12105286", "type"=>"RESULT", "citation"=>"McDuffie JR, Calis KA, Uwaifo GI, Sebring NG, Fallon EM, Hubbard VS, Yanovski JA. Three-month tolerability of orlistat in adolescents with obesity-related comorbid conditions. Obes Res. 2002 Jul;10(7):642-50. doi: 10.1038/oby.2002.87."}, {"pmid"=>"33059389", "type"=>"DERIVED", "citation"=>"Schvey NA, Shank LM, Tanofsky-Kraff M, Ramirez S, Altman DR, Swanson T, Rubin AG, Kelly NR, LeMay-Russell S, Byrne ME, Parker MN, Broadney MM, Brady SM, Yanovski SZ, Yanovski JA. Weight-based teasing in youth: Associations with metabolic and inflammatory markers. Pediatr Obes. 2021 Mar;16(3):e12729. doi: 10.1111/ijpo.12729. Epub 2020 Oct 15."}, {"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."}], "seeAlsoLinks"=>[{"url"=>"http://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_1998-CH-0111.html", "label"=>"NIH Clinical Center Detailed Web Page"}]}, "descriptionModule"=>{"briefSummary"=>"Obesity is a condition affecting one-third off the U.S. population and is a major risk actor for the development of Type 2 diabetes, hyperlipidemia (increased levels of fat in the blood), hypertension (high blood pressure), and other disorders of the heart and lungs. Individuals with the onset of obesity during childhood or adolescence are at an increased risk of obesity-related, diseases, both during adolescence and later in adult life.\n\nAfrican American girls and women are at an increased risk for obesity, and have substantial rates of obesity-related diseases and causes of death. Further, many African American adult women fail to respond to many of the therapeutic approaches used to treat obesity. At present there are no medical therapies proven effective for the correction of severe obesity in children or adolescents.\n\nOne medication that may have a favorable risk-benefit ratio in pediatric populations is Orlistat (Xenical, Hoffmann LaRoche). Orlistat works by preventing the action of enzymes in the digestive process, interfering with the absorption of approximately 1/3 of the fat eaten in the diet. Xenical appears to be effective for reducing weight and obesity-associated diseases in obese adults.\n\nResearchers propose to determine the safety, tolerability, and efficacy of Xenical in 12-17 year old severely obese African American and Caucasian children and adolescents who have one or more obesity-related disease (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin resistance, impaired glucose tolerance, or Type 2 diabetes).", "detailedDescription"=>"Obesity is a condition affecting one-third of the adult U.S. population and is a major risk factor for the development of Type 2 diabetes, hyperlipidemia, hypertension, and other cardiovascular and respiratory disorders. Individuals with the onset of obesity during childhood or adolescence are at increased risk for obesity-related, comorbid conditions, both during adolescence and later in life. African American girls and women are at particular risk for obesity, and have substantial rates of obesity-related morbidity and mortality. Further, African American adult women have a less satisfactory response to many therapeutic approaches used to treat obesity. At present, there are no medical therapies proven effective for the amelioration of severe obesity in children or adolescents. One medication that may have a favorable risk-benefit ratio in pediatric populations is orlistat (Xenical(Trademark), Hoffmann LaRoche). Orlistat acts by inhibiting gastrointestinal lipases, interfering with the absorption of approximately 1/3 of ingested dietary fat. Orlistat appears to be effective for reducing weight and obesity-associated comorbidities in obese adults. We propose to determine the safety, tolerability, and efficacy of orlistat in 12-17 year-old severely obese African American and Caucasian children and adolescents who have one or more obesity-related comorbidity (hypertension, hyperlipidemia, sleep apnea, hepatic steatosis, insulin-resistance, impaired glucose tolerance, or Type 2 diabetes). Under this protocol, we have conducted an open-label pilot study of orlistat in twenty subjects, suggesting orlistat has a similar side effect profile in adolescents as in adults. We wish to determine the safety and efficacy of orlistat in reducing obesity-related comorbidities using a randomized, double-blind, placebo-controlled clinical trial. All study participants will be enrolled in a psycho-educational weight loss program that includes nutrition education, cognitive-behavioral self-monitoring strategies, and promotion of physical activity. We will also study the effects of orlistat on fat preferences, and study the influence of genetic variables on energy expenditure and weight loss during treatment. A group of healthy, non-overweight children and adolescents will complete questionnaires and exercise studies as a control group for interpretation of results in overweight children and adolescents, but will not undergo phlebotomy or receive any medication."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"* INCLUSION CRITERIA:\n\nGood general health. Individuals taking medications for obesity-related comorbid conditions will not be excluded.\n\nObesity: body mass index for age and triceps skinfold above the 95th percentile (determined by NHANES I age-, sex-, and race- specific data). All subjects will be required to be over 60 kg in body weight.\n\nEvidence for a quantifiable obesity-related comorbidity. Examples include: systolic or diastolic hypertension (determined by age-specific charts); frank Type 2 diabetes, impaired glucose tolerance assessed by oral glucose tolerance testing; hyperinsulinemia (defined as a fasting insulin greater than 15 mIU/mL); significant hyperlipidemia (total cholesterol greater than 200 mg/dL, LDL cholesterol greater than 129 mg/dL or fasting triglycerides greater than 200 mg/dL); hepatic steatosis (SGPT or SGOT above normal range with negative hepatitis studies) or sleep apnea documented by a sleep study.\n\nAge 12 to 17 years at the start of the study.\n\nFor girls with childbearing potential, a negative pregnancy test before taking and while taking study medication. Sexually active females must be using an effective form of birth control. These methods include total abstinence (no sex), oral contraceptives (\"the pill\"), an intrauterine device (IUD), levonogestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.\n\nRace of all four grandparents self-identified as either all Caucasian or all African American.\n\nEXCLUSION CRITERIA:\n\nVolunteers will be excluded (and referred to non-experimental treatment programs) for the following reasons:\n\nPresence of renal, hepatic (other than obesity-related steatosis), gastrointestinal, most endocrinologic (e.g., Cushing syndrome), or pulmonary disorders (other than either asthma not requiring continuous medication or sleep apnea-related disorders);\n\nAdolescent girls who are pregnant, who are currently nursing an infant, or who are having unprotected intercourse;\n\nIndividuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study;\n\nSubjects who regularly use prescription medications unrelated to the complications of obesity. Oral contraceptive use will be permitted, provided the contraceptive has been used for at least two months before starting study medication. The use of over-the-counter and prescription medications will be reviewed on a case-by-case basis; depending on the medication, subjects who have continued to take prescription medication for at least 3 months prior to study entry may be eligible;\n\nRecent use (within six months) of anorexiant medications for the purpose of weight reduction;\n\nInability to undergo MRI (e.g., volunteers with metal within their bodies including 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. that are contraindications).\n\nFor pilot study participants, hypersensitivity or allergy to methylene blue. Individuals with documented G6PD deficiency will be excluded.\n\nINCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS:\n\nVolunteers will qualify for inclusion if they meet the following criteria:\n\n1. Good general health.\n2. Age 12-17 years at study entry.\n3. Body mass index (BMI) for age above the 5th percentile and below 85th percentile, which is considered normal weight by CDC growth chart standards.\n4. For females with childbearing potential, a negative pregnancy test at initial evaluation.\n5. Race of all four grandparents self-identified as either all Caucasian or all African American.\n\nEXCLUSION CRITERIA: HEALTHY CONTROL CHILDREN AND ADOLESCENTS:\n\nVolunteers will be excluded for the following reasons:\n\n1. Presence of past or present medical problems which would impair performance during the exercise tests;\n2. Females who are pregnant, or who are currently nursing an infant;\n3. Individuals who have, or whose parent or guardian has, current substance abuse or a psychiatric disorder or other condition that in the opinion of the investigators would impede competence or possibly hinder completion of the study;\n4. Recent weight change of more than 3% of body weight in the past two months;\n5. Recent use (within six months) of anorexiant medications for the purpose of weight reduction;\n6. Physical impairments that would prevent completion of either the walk/run test or the cycle test."}, "identificationModule"=>{"nctId"=>"NCT00001723", "briefTitle"=>"Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Safety and Efficacy of Orlistat (Xenical, Hoffmann LaRoche) in African American and Caucasian Children and Adolescents With Obesity-Related Comorbid Conditions", "orgStudyIdInfo"=>{"id"=>"980111"}, "secondaryIdInfos"=>[{"id"=>"98-CH-0111", "type"=>"OTHER", "domain"=>"NICHD IRB"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program", "interventionNames"=>["Drug: Placebo"]}, {"type"=>"EXPERIMENTAL", "label"=>"Orlistat", "description"=>"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program", "interventionNames"=>["Drug: Orlistat"]}], "interventions"=>[{"name"=>"Orlistat", "type"=>"DRUG", "otherNames"=>["Xenical (orlistat)capsules"], "description"=>"Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.", "armGroupLabels"=>["Orlistat"]}, {"name"=>"Placebo", "type"=>"DRUG", "otherNames"=>["Placebo capsule"], "description"=>"Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.", "armGroupLabels"=>["Placebo"]}]}, "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"=>"Jack Yanovski", "class"=>"NIH"}, "collaborators"=>[{"name"=>"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)", "class"=>"NIH"}, {"name"=>"Roche Pharma AG", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR_INVESTIGATOR", "investigatorTitle"=>"Section Chief, Section on Growth and Obesity, PDEGEN, NICHD", "investigatorFullName"=>"Jack Yanovski", "investigatorAffiliation"=>"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)"}}}}