Post Diabetes Prevention Program Follow-up Study
Post Diabetes Prevention Program Follow-up Study
批准号:
7189340
负责人:
Ronald B Goldberg
金额:
$26.96万
依托单位国家:
美国
项目类别:
财政年份:
1994
资助国家:
美国
项目状态:
已结题
起止时间:
1994-08-20 至 2009-01-31
关键词:
2,4-thiazolidinedioneAccountingAddressAdoptedAdultAdvisory CommitteesAffectAfricanAfrican AmericanAgeAge-YearsAgingAirAlbuminsAmericanAnkleAnthropometryAntioxidantsAnxietyAppearanceAppendixArterial Fatty StreakAsiansAsorbicapAtherosclerosisAutopsyBehavior TherapyBehavioralBeta CellBiochemicalBiochemistryBlood GlucoseBlood PressureBody Weight decreasedBudgetsCalendarCaliberCardiovascular DiseasesCardiovascular systemCategoriesCationsCaucasiansCaucasoid RaceCell physiologyCenters for Disease Control and Prevention (U.S.)CharacteristicsCholesterolChronicChronic DiseaseCitiesClassificationClinicalClinical ResearchClinical TrialsClosureCohort EffectCollaborationsCollectionCombined Modality TherapyComplicationComplications of Diabetes MellitusConceptionsConditionConsensusControl GroupsControlled Clinical TrialsControlled StudyCoronaryCoronary ArteriosclerosisCosts and BenefitsCox ModelsCreatinineCross-Sectional StudiesCystatinsDataData AnalysesDevelopmentDiabetes MellitusDiabetes preventionDiabetic AngiopathiesDiabetic MicroangiopathiesDiabetic NephropathyDiabetic RetinopathyDiagnosisDiagnosticDietary intakeDiseaseDisease OutcomeDisease regressionDistalDropoutDyslipidemiasEconomic ModelsEconomicsEffectivenessEffectiveness of InterventionsElectrocardiogramEnd PointEnrollmentEpidemiologic StudiesEpidemiologyErythrocytesEthnic OriginEvaluationEventEvolutionExcretory functionExerciseExposure toFailureFastingFibrinogenFollow-Up StudiesFrequenciesFunctional disorderFundingFundusFundus photographyGenderGeneral PopulationGillsGlucoseGlucose IntoleranceGlucose tolerance testGoalsGrantGraphGroup MeetingsHazard ControlsHealthHealth BenefitHealth Care CostsHealth PersonnelHealth ProfessionalHealthcareHeart DiseasesHemoglobinHemostatic AgentsHeterogeneityHigh Blood PressureHigh Density Lipoprotein CholesterolHigh Pressure Liquid ChromatographyHigh PrevalenceHip region structureHispanicsHomocysteineHomocystineHourHyperglycemiaHyperlipidemiaHypertensionHypotensionIncidenceIndividualInstitutesInsulinInsulin ResistanceInsulin-Like Growth Factor IIntakeIntentionInterventionInvasiveInvestigationKidneyKidney DiseasesKnowledgeLDL Cholesterol LipoproteinsLaboratoriesLeftLifeLife StyleLife Table AnalysesLife Table EstimateLife Table MethodLife TablesLightLinear ModelsLinkLipidsLipoproteinsLiving CostsLogistic ModelsLong-Term EffectsLongitudinal StudiesLow-Level Laser TherapyMasksMatched-Pair AnalysisMeasurementMeasuresMedialMedical HistoryMedicineMental DepressionMetabolicMetforminMethodsMichiganMicroalbuminuriaMicroaneurysmMindMinorityModelingModificationMonitorMorbidity - disease rateMulticenter StudiesMyocardial InfarctionNational Eye InstituteNational Health and Nutrition Examination SurveyNational Institute of Diabetes and Digestive and Kidney DiseasesNatural HistoryNatureNeurologicNeuropathyNewly DiagnosedNon-Insulin-Dependent Diabetes MellitusNot Hispanic or LatinoNumbersNutrientOGTTObesityObservational StudyOphthalmologistOrganOther FindingOutcomeOutcome MeasurePaired ComparisonPaperParticipantParticle SizePathogenesisPatientsPeripheral Nervous System DiseasesPersonal SatisfactionPersonsPharmaceutical PreparationsPhasePhotographyPhysical ExaminationPhysical activityPima IndianPlacebosPlasmaPlasminogen Activator Inhibitor 1PlayPopulationPopulation StudyPopulations at RiskPre-studyPredispositionPremenopausePrevalencePreventionPrimary PreventionPrincipal InvestigatorProceduresProcessProcess MeasureProspective StudiesProteinsProtocols documentationPsychological reinforcementPublic HealthPurposeQuality of lifeQuestionnairesRaceRandom AllocationRandomizedRangeRateReadingRecording of previous eventsReflex actionRelative (related person)Relative RisksReportingResearchResearch DesignResearch PersonnelResearch TrainingResistanceResourcesRetinal DiseasesRiskRisk EstimateRisk FactorsRisk ReductionRoleSF-36Sample SizeSamplingScanningScheduleScreening procedureSelection BiasSelf-AdministeredSideSignificance LevelSodium ChlorideSpecific qualifier valueSpottingsStagingStandards of Weights and MeasuresStatistically SignificantStratificationStrokeSubgroupSuggestionSurveysSymptomsTNF geneTechniquesTest ResultTestingThiazolidinedionesThickThinkingTicksTimeTissuesTouch sensationTranslatingTranslationsTreatment EffectivenessTriglyceridesUltrasonographyUnited States Public Health ServiceUniversitiesUpper armUric AcidUrineVascular DiseasesVisitVisualWeekWeightWisconsinWomanWorld Health Organizationadjudicatebasecardiovascular disorder riskcardiovascular risk factorclinical Diagnosiscohortcomparison groupcostcost effectivenesscysteine rich proteindemographicsdesigndiabetes prevention programdiabetes riskdiabeticearly onsetepidemiology studyexperiencefollow-upglucose toleranceglycationhazardillness lengthimpaired glucose toleranceimprovedindexinginsightinstrumentinterestintervention programlife time costlifestyle interventionmembermenmortalitynon-diabeticoral glucose tolerancepre-clinicalpreventprognosticprogramsprospectiveracial and ethnicsexsizestereoscopictooltreatment durationtreatment effecttype I diabeticurinaryvolunteer
中文摘要
描述(由申请人提供):
糖尿病预防计划是一项多中心对照临床试验
检查强化生活方式干预或二甲双胍的疗效,
预防或延迟糖尿病在选择为处于以下的人群中的发展:
由于存在葡萄糖耐量受损(IGT),风险较高。发展
根据1997年ADA标准定义的糖尿病是主要结局,
心血管疾病及其危险因素是重要的次要结局。
检察长办公室于1996年年中开始征聘。截至本申请提交之时,
研究暴露的平均时间约为3年(范围为2 - 5年),
3组中3,234名志愿者的约10,000患者年
study.基于统计学显著性和临床强制性
在生活方式干预中减少糖尿病的发展,
二甲双胍治疗组(分别减少58%和31%),
安慰剂治疗组、DPP数据监测委员会和NIDDK结束了
2001年5月,研究的设盲治疗阶段,比2002年5月提前一年。
原计划。
此应用程序旨在进一步利用科学
具有临床价值的DPP志愿者队列和大量数据
在研究过程中收集的。高依从性DPP队列,包括45%
少数民族,是有史以来最大的IGT人群。此外,子队列
已经发展成糖尿病的人(n约700),
糖尿病发病的确切时间临床重要研究问题
在民进党之后。仔细收集,集中测量,
这个队列中的分级数据应该有助于明确回答一些问题,
关于IGT和早发2型临床病程的重要问题
糖尿病具体目标包括:1.检查长期影响,
DPP先前干预对DPP主要成果的持久性,包括
糖尿病、临床心血管疾病、动脉粥样硬化、CVD危险因素,
生活质量和成本效益; 2.确定新发病例的临床病程
2型糖尿病和IGT,特别是关于微血管和神经系统
并发症; 3.确定心血管疾病(CVD)的发病率,CVD
新发2型糖尿病和IGT的危险因素和动脉粥样硬化;和4.
在少数群体、男性与女性以及老年人中研究主题1-3
DPP中的主题。目前的申请是5年的资助,
尽管所描述的项目的一些目标将需要10年的时间,
study.
英文摘要
DESCRIPTION (provided by applicant):
The Diabetes Prevention Program is a multicenter controlled clinical trial
examining the efficacy of an intensive life-style intervention or metformin to
prevent or delay the development of diabetes in a population selected to be at
high risk due to the presence of impaired glucose tolerance (IGT). Development
of diabetes, defined by 1997 ADA criteria, is the primary outcome while
cardiovascular disease and its risk factors are important secondary outcomes.
The DPP began recruitment in mid-1996. At the time of this application, total
study exposure is a mean of approximately 3 years (range 2 to 5) with a total
of approximately 10,000 patient years in the 3,234 volunteers in the 3-arm
study. On the basis of a statistically significant and clinically compelling
decrease in the development of diabetes in the life-style intervention and
metformin-treated groups (58% and 31% reductions, respectively) compared with
the placebo treated group, the DPP Data Monitoring Board and NIDDK ended the
masked treatment phase of the study in May, 2001, one year earlier than
originally planned.
This application is designed to take further advantage of the scientifically
and clinically valuable cohort of DPP volunteers and the large volume of data
collected during the study. The highly compliant DPP cohort, including 45%
minorities, is the largest IGT population ever studied. Moreover, the subcohort
that has developed diabetes (n approximately 700) has been followed from near
the exact time of diabetes onset. Clinically important research questions
remain in the wake of the DPP. The carefully collected, centrally measured and
graded data in this cohort should help to answer, definitively, a number of
important questions regarding the clinical course of IGT and early onset type 2
diabetes. Specific aims include: 1. Examine the long-term effects and
durability of prior DPP intervention on the major DPP outcomes including
diabetes, clinical cardiovascular disease, atherosclerosis, CVD risk factors,
quality of life and cost-benefit; 2. Determine the clinical course of new onset
type 2 diabetes and IGT, in particular regarding microvascular and neurologic
complications; 3. Determine the incidence of cardiovascular disease (CVD), CVD
risk factors and atherosclerosis in new onset type 2 diabetes and IGT; and 4.
Examine topics 1-3 in minority populations, men vs. women, and in older
subjects in the DPP. The current application is for 5 years of funding,
although the some of the goals of the projects described will require a 10-year
study.
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会议论文
Biomarkers and Outcomes in the Diabetes Prevention Program
-
批准号:7821189
-
项目类别:
-
资助金额:$50.51万
-
财政年份:2008
-
负责人:Ronald B Goldberg
-
依托单位:
Biomarkers and Outcomes in the Diabetes Prevention Program
-
批准号:7610881
-
项目类别:
-
资助金额:$49.71万
-
财政年份:2008
-
负责人:Ronald B Goldberg
-
依托单位:
Biobehavioral Bases & Management of Metabolic Syndrome
-
批准号:7248203
-
项目类别:
-
资助金额:$52.73万
-
财政年份:2007
-
负责人:Ronald B Goldberg
-
依托单位:
Core--Endocrinology and Metabolism
-
批准号:7248213
-
项目类别:
-
资助金额:$23.65万
-
财政年份:2007
-
负责人:Ronald B Goldberg
-
依托单位:
DIABETES PREVENTION PROGRAM OUTCOMES STUDY
-
批准号:7203251
-
项目类别:
-
资助金额:$3.4万
-
财政年份:2005
-
负责人:Ronald B Goldberg
-
依托单位:
CORE B--
-
批准号:6988837
-
项目类别:
-
资助金额:$11.7万
-
财政年份:2004
-
负责人:Ronald B Goldberg
-
依托单位:
Diabetes Prevention Program Outcomes Study
-
批准号:6981357
-
项目类别:
-
资助金额:$7.81万
-
财政年份:2004
-
负责人:Ronald B Goldberg
-
依托单位:
Post DPP Follow-up Study
-
批准号:7023262
-
项目类别:
-
资助金额:$41.46万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
DDP LONG-TERM FOLLOW-UP STUDY
-
批准号:7792234
-
项目类别:
-
资助金额:$45.9万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
Post Diabetes Prevention Program Follow-up Study
-
批准号:7354795
-
项目类别:
-
资助金额:$44.16万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
04/22 Diabetes Prevention Program Outcomes Study (DPPOS) Phase 3 – Research Project
-
批准号:9319872
-
项目类别:
-
资助金额:$3.99万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
NIDDM PRIMARY PREVENTION TRIAL (DPT-2)
-
批准号:2148717
-
项目类别:
-
资助金额:$59.9万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
NIDDM PRIMARY PREVENTION TRIAL (DPT-2)
-
批准号:2436698
-
项目类别:
-
资助金额:$4.07万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
NIDDM PRIMARY PREVENTION TRIAL (DPT-2)
-
批准号:2734174
-
项目类别:
-
资助金额:$58.26万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
NIDDM PRIMARY PREVENTION TRIAL (DPT-2)
-
批准号:2905658
-
项目类别:
-
资助金额:$64.1万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
4/22 Limited Competition for the Continuation of the Diabetes Prevention Program Outcomes Study (DPPOS) – Clinical Center
-
批准号:10653521
-
项目类别:
-
资助金额:$10.18万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
NIDDM PRIMARY PREVENTION TRIAL (DPT-2)
-
批准号:2148718
-
项目类别:
-
资助金额:$56.13万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
NIDDM PRIMARY PREVENTION TRIAL (DPT 2)
-
批准号:2834883
-
项目类别:
-
资助金额:$4.92万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
NIDDM PRIMARY PREVENTION TRIAL (DPT-2)
-
批准号:6380913
-
项目类别:
-
资助金额:$68.47万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
DDP LONG-TERM FOLLOW-UP STUDY
-
批准号:7664664
-
项目类别:
-
资助金额:$45.9万
-
财政年份:1994
-
负责人:Ronald B Goldberg
-
依托单位:
海外基金