Diabetes and Periodontics Trial - Coordinating Center
糖尿病和牙周病试验 - 协调中心
基本信息
- 批准号:8102015
- 负责人:
- 金额:$ 80.93万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2008
- 资助国家:美国
- 起止时间:2008-07-21 至 2013-06-30
- 项目状态:已结题
- 来源:
- 关键词:Academic Medical CentersAddressAdultAreaBenefits and RisksBlood GlucoseC-reactive proteinCaringCertificationClinicClinicalClinical TrialsClinical Trials Data Monitoring CommitteesClinical Trials DesignCommunicationComplications of Diabetes MellitusControl GroupsDataData AnalysesData CollectionData QualityDental ClinicsDentistryDevelopmentDiabetes MellitusDiseaseEarly treatmentEffectivenessEligibility DeterminationEnrollmentEpidemiologyGingival IndexesGlycosylated HemoglobinGlycosylated hemoglobin AHealthHealth Care CostsHemorrhageHomeostasisHuman ResourcesIndividualInflammationInsulin ResistanceInterleukin-6Intervention StudiesLaboratoriesManualsMasksMeasuresMetabolicMetabolic ControlModelingMonitorNational Institute of Dental and Craniofacial ResearchNew YorkNon-Insulin-Dependent Diabetes MellitusOral healthOutcomeOutcome StudyPatientsPeriodontal DiseasesPeriodontic specialtyPeriodontitisPhase III Clinical TrialsPhiladelphiaPlasmaProceduresProcessProtocols documentationPublicationsRandomizedRecruitment ActivityReportingResearch PersonnelSafetySample SizeSerumStandardizationSurgeonSystemTestingUnited StatesUniversitiesVisitclinically relevantcomputerized data processingdata managementdesignfasting glucosefollow-upglycemic controlimprovedinflammatory markermedical schoolsmeetingspreventquality assuranceresponsescaling and root planingtreatment responsetumor
项目摘要
The 2000 Surgeon General's Report on Oral Health identified the relationship between
improvement in periodontal health and glycemic control as an area in need of intervention studies. To
date there has been no adequately powered clinical trial to address this question. The Diabetes and
Periodontics Trial (DPT) is a multi-center, randomized, controlled single-masked Phase III clinical trial
designed to address this need. The study will test whether non-surgical periodontal therapy (scaling
and root planing) is effective in reducing HbA1c of patients with type 2 diabetes and untreated chronic
periodontitis compared to a control group receiving no treatment. The primary study outcome will be
change in HbA1c values at 6 months. Delayed treatment will be offered to the control group after the 6-
month visit. Secondary aims will evaluate whether improvement in clinical measures of chronic
periodontitis is related to changes in systemic inflammatory markers, HbA1c, and measures of insulin
resistance in these patients.
The proposed DPT is a collaborative effort that involves four Clinical Centers from Schools of
Medicine and Dentistry in Birmingham, AL; Philadelphia, PA; San Antonio, TX; and Minneapolis, MN; a
Core HbA1c Laboratory, also in Minneapolis, MN; a Study Chair's office, a Coordinating Center, and a
Core Metabolic Laboratory, all at Stony Brook University, Stony Brook, New York. An independent
Data and Safety Monitoring Board (DSMB) will evaluate the data at least annually to assess the risks
and benefits of periodontal treatment. Six hundred adults (150/center) meeting specific eligibility
criteria will be enrolled over a 2.5 year period and examined at baseline, 3 and 6 months; a
standardized common protocol and a detailed Manual of Procedures will be used at all centers. This
application seeks support for the activities of the Coordinating Center (CC). The major CC
responsibilities include: 1) serving as a collaborative partner and providing epidemiologic and
biostatistical expertise to the organization, design, conduct and analysis of the trial; 2) collaborating in
the development and distribution of forms, documents and protocols; 3) responsibility for data
management, processing and analysis; 4) developing, implementing and monitoring the randomization
process; 5) preparing periodic reports to monitor study activities, safety issues, outcomes and data
quality for the DSMB and routine monitoring reports for the other study committees; 6) participating in
the design, analysis and publication of the study results; 7) responsibility for quality assurance
protocols; 8) coordinating and documenting DSMB meetings; and, 9) collaborating with the Study Chair
to coordinate and document study meetings and communications among centers. Separate
applications have been submitted by the Study Chair and the four Clinical Centers. Having periodontal (gum) disease may make it more difficult to control blood sugar levels for people
with type 2 diabetes. This study will test whether non-surgical periodontal disease treatment leads to
improved blood sugar control. Improving the way people manage their blood sugar is key to preventing
diabetes complications and reducing health care costs.
2000年卫生局局长的口腔健康报告确定了两者之间的关系
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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LESLIE G HYMAN其他文献
LESLIE G HYMAN的其他文献
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{{ truncateString('LESLIE G HYMAN', 18)}}的其他基金
Collaborative Observational Study of Myopia in COMET Children 2-Coordinating Ctr
COMET儿童近视的协作观察研究2-协调中心
- 批准号:
7893292 - 财政年份:2009
- 资助金额:
$ 80.93万 - 项目类别:
Diabetes and Periodontics Trial - Coordinating Center
糖尿病和牙周病试验 - 协调中心
- 批准号:
7882462 - 财政年份:2008
- 资助金额:
$ 80.93万 - 项目类别:
Diabetes and Periodontics Trial - Coordinating Center
糖尿病和牙周病试验 - 协调中心
- 批准号:
8270740 - 财政年份:2008
- 资助金额:
$ 80.93万 - 项目类别:
Diabetes and Periodontics Trial - Coordinating Center
糖尿病和牙周病试验 - 协调中心
- 批准号:
8291900 - 财政年份:2008
- 资助金额:
$ 80.93万 - 项目类别:
Diabetes and Periodontics Trial - Coordinating Center
糖尿病和牙周病试验 - 协调中心
- 批准号:
7435736 - 财政年份:2008
- 资助金额:
$ 80.93万 - 项目类别:
Diabetes and Periodontics Trial - Coordinating Center
糖尿病和牙周病试验 - 协调中心
- 批准号:
8126662 - 财政年份:2008
- 资助金额:
$ 80.93万 - 项目类别:
Diabetes and Periodontics Trial - Coordinating Center
糖尿病和牙周病试验 - 协调中心
- 批准号:
7661538 - 财政年份:2008
- 资助金额:
$ 80.93万 - 项目类别:
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