Investigation of Medical Management to Prevent Episodes of Diverticulitis (IMPEDE) Trial

预防憩室炎发作的医疗管理研究 (IMPEDE) 试验

• 批准号: 10536190
• 负责人: David R Flum
• 金额: $ 26.44万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10536190
• 关键词: Address; Adherence; Ambulatory Care Facilities; American; Behavior Therapy; Behavioral; Biological Markers; Body mass index; Budgets; Cardiovascular system; Characteristics; Chronic; Clinical; Clinical Trials; Colectomy; Cross-Sectional Studies; Custom; Development; Diet; Dietary Component; Dietary Fiber; Dietary Intervention; Dietary Practices; Disease; Diverticulitis; Drug usage; Emergency department visit; Exercise; Feces; Feedback; Fiber; Food; Food Patterns; Future; Guidelines; Health Food; Health behavior; Hospitalization; Hour; Incidence; Individual; Inflammation; Inflammatory; Inpatients; Intake; Interleukin-1 beta; Interleukin-10; Interleukin-6; Intervention; Intervention Trial; Investigation; Joints; Knowledge; Leukocyte L1 Antigen Complex; Life Style; Link; Malignant Neoplasms; Meat; Medical; Mediterranean Diet; Mission; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Nature; Non-Steroidal Anti-Inflammatory Agents; Nutrient; Obesity; Observational Study; Outcome; Outpatients; Pain; Participant; Pathogenesis; Pathway interactions; Patients; Pattern; Pharmacology; Plasma; Prevalence; Prevention; Preventive measure; Primary Prevention; Prospective cohort study; Provider; Quality of life; Randomized; Randomized Controlled Trials; Recording of previous events; Recurrence; Risk; Risk Factors; Sampling; Secondary Prevention; Serum; Smoke; Smoking; Standardization; United States Department of Agriculture; Visit; Work; base; circulating biomarkers; colon surgery; cost; density; dietary; dietary guidelines; effectiveness evaluation; effectiveness trial; evidence base; feasibility trial; food restriction; gastrointestinal; gut microbiome; gut microbiota; high risk; improved; inflammatory marker; men; modifiable lifestyle factors; modifiable risk; novel; nutritional epidemiology; physical inactivity; pilot trial; preference; prevent; preventive intervention; prospective; randomized trial; response; response biomarker; systemic inflammatory response; treatment response; willingness

ABSTRACT This application proposes a pilot feasibility randomized trial of the USDA Healthy Mediterranean-style Food Pattern versus standardized guidance on fiber intake for patients with diverticulitis in response to PAS-20-160, Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK. Diverticulitis is one of the most common gastrointestinal indications for inpatient hospital admission, outpatient clinic and emergency room visits, and colon surgery. At least 20% of individuals with an initial episode of diverticulitis will have one or more painful and unpredictable recurrences. Unfortunately, there is no proven pharmacologic means to decrease the risk of diverticulitis. Large, prospective, observational studies have identified diet and lifestyle risk factors for incident diverticulitis. In one study, men who adhered to a low-risk profile (< 51g/day red meat, >23g/day fiber, 2 hours exercise/week, normal BMI, and never smoked) were 75% less likely to develop incident diverticulitis. However, these modifiable risk factors have not been evaluated for secondary prevention. Studies of diet and plasma inflammatory markers suggest that chronic, systemic inflammation is a potential mechanism that underlies the dietary effects on diverticulitis development. The Mediterranean diet pattern is comparable to diets associated with primary prevention of diverticulitis, is more strongly associated with reduced inflammation, and is familiar to providers and many patients. Thus, we propose to conduct a randomized trial (n=75) of a USDA Healthy Med- style Food Pattern versus standardized guidance on fiber intake for patients with diverticulitis to evaluate the feasibility of this dietary intervention including willingness to randomize and adherence to a Med-style dietary pattern. We will employ state-of-the-art behavioral interventions in the form of electronic feedback to improve health-related behaviors and support dietary customization based on participant’s budget, dietary preferences, and restrictions. We will also examine plasma inflammatory biomarkers (interleukin-6, interleukin-10, and interleukin-1β) and fecal calprotectin at baseline, 6, and 12 months. The proposed feasibility trial will set the groundwork for a large multicenter RCT of a food pattern–behavioral intervention versus standardized guidance on fiber intake in patients with a history of diverticulitis. It will also expand our knowledge of inflammation and diverticulitis pathogenesis and gather prospectively collected samples for future biomarker study. Ultimately, given the prevalence and morbidity of diverticulitis and the lack of predictive and preventative measures, identifying a proven means of secondary prevention and a biomarker of risk would change treatment paradigms and improve the lives of millions of patients with diverticulitis.

抽象的 该申请提出一项飞行员可行性随机试验的随机试验 针对憩室炎患者的纤维摄入纤维摄入的模式与标准化指南，以响应PAS-20-160， 针对NIDDK任务内疾病的临床试验的小型R01。憩室炎是最多的 住院住院，门诊诊所和急诊就诊的常见胃肠道迹象， 和结肠手术。至少有20％的患有憩室炎发作的人将有一个或多个痛苦 和不可预测的回报。不幸的是，没有证实的药物学方法可以降低 憩室炎。大型，前瞻性，观察性研究已经确定了事件的饮食和生活方式风险因素 憩室炎。在一项研究中，坚持低风险的男性（<51克/天红肉，> 23克/天纤维，2小时 锻炼/周，BMI正常，从未吸烟）患有事件憩室炎的可能性降低了75％。然而， 这些可修改的危险因素尚未评估用于二级预防。饮食和血浆研究 炎症标记表明，慢性全身感染是一种潜在的机制，其基础是 饮食对憩室炎发育的影响。地中海饮食模式与饮食相关 通过主要预防憩室炎，与感染的降低更加密切相关，并且很熟悉 提供者和许多患者。这，我们建议对USDA健康的Med-进行随机试验（n = 75） 样式食品模式与憩室炎患者纤维摄入的标准化指南，以评估 这种饮食干预的可行性，包括愿意随机和依从性饮食 图案。我们将采用电子反馈形式采用最新的行为干预措施来改善 根据参与者的预算，饮食偏爱，与健康有关的行为和支持饮食定制， 和限制。我们还将检查血浆炎症生物标志物（白介素6，白介素10和 基线，6和12个月时，白介素-1β）和粪便钙蛋白钙蛋白钙斑蛋白。拟议的可行性审判将设定 大型食品模式的大型多中心RCT的基础 - 行为干预与标准化指导 关于憩室炎史的患者的纤维摄入量。它还将扩大我们对炎症的了解和 憩室炎发病机理并收集前瞻性收集的样品，以进行未来的生物标志物研究。最终， 鉴于憩室炎的流行和发病率以及缺乏预测性和预防措施 确定一种经过验证的二级预防手段和风险生物标志物将改变治疗范例 并改善数百万憩室炎患者的生活。