Toward Repurposing a Commonly-Used Medication for the Treatment of Pediatric Severe Obesity
Toward Repurposing a Commonly-Used Medication for the Treatment of Pediatric Severe Obesity
批准号:
10711874
负责人:
Claudia K Fox
金额:
$30.91万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-08-15 至 2026-06-30
关键词:
AcuteAdolescenceAdolescentAdultAffectAgeAgonistAttention deficit hyperactivity disorderBinge EatingBinge eating disorderBody CompositionBody fatBody mass indexCardiovascular DiseasesCharacteristicsChildChildhoodChronic DiseaseClinicClinical TrialsDataDesire for foodDietDiseaseDisease OutcomeDopamineDoseDouble-Blind MethodDrug PrescriptionsEatingEating BehaviorEducationEmploymentEnergy IntakeEnergy MetabolismFDA approvedFamiliarityFinancial HardshipFunctional disorderGLP-I receptorGoalsGrowthHealthHealth behaviorHeart RateInformal Social ControlInjectionsInterventionLifestyle TherapyMalignant NeoplasmsMental DepressionMetabolic syndromeMissionMorbid ObesityMorbidity - disease rateNamesNational Institute of Diabetes and Digestive and Kidney DiseasesNorepinephrineObesityObstructive Sleep ApneaOralParticipantPharmaceutical PreparationsPhasePhenterminePhysical activityPilot ProjectsPlacebo ControlPlacebosPlayPopulationPremature MortalityPublic HealthQuality of lifeRandomizedRandomized, Controlled TrialsRecommendationRestRewardsRoleSafetySocietiesTranslatingVyvanseWeightWeight GainWeight maintenance regimenYouthblood pressure elevationcardiometabolismclinically significantcomorbiditycostdesignefficacy evaluationexecutive functionfeasibility trialhigh risk populationimprovedimproved outcomeliraglutidemetabolic ratenon-alcoholic fatty liver diseaseobesity in childrenobesity treatmentpediatricianpharmacologicphase 3 studypilot trialplacebo grouppreadolescenceprimary endpointprimary outcomepsychostimulantpublic health relevancerandomized placebo-controlled clinical trialreuptakereward processingsecondary outcomesexsocialtreatment effect
中文摘要
项目总结/文摘
英文摘要
Project Summary/Abstract
Severe obesity in children is a highly prevalent, serious and chronic disease that directly leads to severe obesity
in adults and the subsequent enormous social and financial burden on society. Lifestyle therapy is the
cornerstone of pediatric obesity treatment, but this intervention when used alone is often insufficient for achieving
clinically significant and durable BMI reduction. Adjunct anti-obesity medications may improve outcomes of this
disease, but the pharmacological options used for obesity in children are extremely limited. Thus there is an
urgency to identify anti-obesity medications for use in the pediatric population, which are safe, effective, easily
administered and affordable. Psychostimulants, the second most commonly prescribed class of medications in
children, have a long-standing safety profile and because of their favorable effect on weight, may serve as a
useful adjunct to lifestyle therapy for the treatment of severe obesity in this population. Thus, the goal of this pilot
and feasibility clinical trial is to estimate the treatment effect of a common psychostimulant, lisdexamfetamine,
for the treatment of severe obesity in children. Specifically, 44 children ages 6 to <12 years with severe obesity
(BMI ≥120% of the 95th percentile) will be randomized, 1:1, to lisdexamfetamine plus lifestyle therapy or placebo
plus lifestyle therapy for 24 weeks of treatment. The primary outcome of the main aim will be change in BMI,
and secondary outcomes will include changes in body composition, cardiometabolic health, and quality of life.
The second aim will be to identify participant tolerability of the recommended starting dose of lisdexamfetamine
and the emergence of clinically significant increases in blood pressure and heart rate. Potential mechanisms by
which lisdexamfetamine reduces BMI will also be explored including changes in executive functioning, reward
processing, appetite, resting energy expenditure, and health behaviors (diet, eating behaviors, and physical
activity). The results of this pivotal pilot trial will directly inform the conduct of the larger, fully powered, definitive
study, which ultimately, by identifying a safe, effective and scalable treatment, will improve the outcomes of the
millions of children affected by this serious, chronic disease.
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会议论文
SMART Use of Medication for the Treatment ofAdolescent Severe Obesity
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批准号:10657656
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项目类别:
-
资助金额:$53.99万
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财政年份:2019
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负责人:Claudia K Fox
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依托单位:
SMART Use of Medication for the Treatment ofAdolescent Severe Obesity
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批准号:10207618
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项目类别:
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资助金额:$66.89万
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财政年份:2019
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负责人:Claudia K Fox
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依托单位:
SMART Use of Medication for the Treatment ofAdolescent Severe Obesity
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批准号:10435514
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项目类别:
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资助金额:$66.06万
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财政年份:2019
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负责人:Claudia K Fox
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依托单位:
SMART Use of Medication for the Treatment ofAdolescent Severe Obesity
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批准号:9816319
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项目类别:
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资助金额:$65.11万
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财政年份:2019
-
负责人:Claudia K Fox
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依托单位:
海外基金