Diabetes and Periodontics Trial - Coordinating Center

2000年卫生局局长关于口腔健康的报告确定了 改善牙周健康和血糖控制是一个需要干预研究的领域。至 迄今为止，还没有足够有力的临床试验来解决这个问题。糖尿病和 牙周病试验(DPT)是一项多中心、随机、对照的单盲III期临床试验 旨在满足这一需求。这项研究将测试非手术牙周治疗(洁牙术) 和根面平整)可有效降低未经治疗的慢性2型糖尿病患者的糖化血红蛋白 将牙周炎患者与未接受治疗的对照组进行比较。主要研究结果将是 6个月时HbA1c的变化。对照组在6-6岁后给予延迟治疗。 一个月的访问。二级目标将评估慢性阻塞性肺疾病临床措施的改善 牙周炎与全身炎症标志物、糖化血红蛋白和胰岛素水平的变化有关 这些患者的耐药性。 拟议的DPT是一项合作努力，涉及来自以下学校的四个临床中心 亚利桑那州伯明翰、宾夕法尼亚州费城、德克萨斯州圣安东尼奥和明尼阿波利斯州明尼阿波利斯的医学和牙科 核心HbA1c实验室，也在明尼苏达州明尼阿波利斯；一个研究教席办公室，一个协调中心和一个 核心新陈代谢实验室，全部在纽约石溪大学。无党派人士 数据和安全监测委员会(DSMB)将至少每年对数据进行评估，以评估风险 以及牙周治疗的好处。满足特定资格的600名成年人(150人/中心) 标准将在2.5年内纳入，并在基线、3个月和6个月进行审查；a 所有中心都将使用标准化的共同协议和详细的程序手册。这 申请寻求对协调中心(CC)活动的支持。主要的CC 职责包括：1)作为合作伙伴，提供流行病学和 为试验的组织、设计、实施和分析提供生物统计学专业知识；2)在 编制和分发表格、文件和协议；3)负责数据 管理、处理和分析；4)制定、实施和监测随机化 过程；5)编写定期报告，以监测研究活动、安全问题、结果和数据 Dsmb的质量和其他研究委员会的常规监测报告；6)参与 研究结果的设计、分析和发布；7)负责质量保证 协议；8)协调和记录DSMB会议；以及9)与研究主席合作 协调和记录各中心之间的学习会议和交流。各别 研究主席和四个临床中心已经提交了申请。患有牙周病可能会使人们更难控制血糖水平 患有2型糖尿病。这项研究将测试非手术牙周病治疗是否会导致 改善血糖控制。改善人们管理血糖的方式是预防 糖尿病并发症和降低医疗保健成本。

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.