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: 10674864
• 负责人: David R Flum
• 金额: $ 25.76万
• 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/10674864
• 关键词: Address; Adherence; Ambulatory Care Facilities; American; Behavior Therapy; Behavioral; Biological Markers; Body mass index; Budgets; Characteristics; Chronic; Clinical; Clinical Trials; Colectomy; Cross-Sectional Studies; Development; Diagnostic; Diet; Dietary Component; Dietary Fiber; Dietary Intervention; Dietary Practices; Disease; Diverticulitis; Drug usage; Electronics; 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; Plasma; Prevalence; Prevention; Preventive measure; Primary Prevention; Prospective, cohort study; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Recording of previous events; Recurrence; Risk; Risk Factors; Sampling; Secondary Prevention; Serum; Smoke; Smoking; Standardization; United States Department of Agriculture; Visit; Work; cardiovascular disorder prevention; 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 population; improved; inflammatory marker; men; modifiable lifestyle factors; modifiable risk; novel; nutritional epidemiology; pharmacologic; physical inactivity; pilot trial; preference; prevent; preventive intervention; prospective; randomized trial; relapse prevention; 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 该申请提出了美国农业部健康地中海风味食品的试点可行性随机试验 憩室炎患者对 PAS-20-160 的纤维摄入量模式与标准化指导， 用于 NIDDK 使命范围内针对疾病的临床试验的小型 R01。憩室炎是最常见的疾病之一 住院、门诊和急诊室就诊的常见胃肠道适应症， 和结肠手术。至少 20% 初次发生憩室炎的人会出现一种或多种疼痛 以及不可预测的复发。不幸的是，没有经过证实的药理学方法可以降低风险 憩室炎。大型、前瞻性、观察性研究已确定饮食和生活方式的风险因素 憩室炎。在一项研究中，坚持低风险饮食的男性（< 51 克/天红肉，> 23 克/天纤维，2 小时 每周锻炼、体重指数正常且从不吸烟）发生憩室炎的可能性降低 75%。然而， 这些可改变的危险因素尚未经过二级预防评估。饮食和血浆研究 炎症标志物表明，慢性全身炎症是潜在的机制 饮食对憩室炎发展的影响。地中海饮食模式与相关饮食模式相当 与憩室炎的一级预防，与减少炎症密切相关，并且熟悉 提供者和许多患者。因此，我们建议对 USDA Healthy Med- 进行一项随机试验 (n=75) 风格的食物模式与憩室炎患者纤维摄入的标准化指导来评估 这种饮食干预的可行性，包括随机化的意愿和坚持医学式饮食 图案。我们将采用电子反馈形式的最先进的行为干预措施来改善 健康相关行为并支持根据参与者的预算、饮食偏好进行饮食定制， 和限制。我们还将检查血浆炎症生物标志物（白细胞介素 6、白细胞介素 10 和 基线、6 个月和 12 个月时的白介素-1β）和粪便钙卫蛋白。拟议的可行性试验将确定 食物模式的大型多中心随机对照试验的基础——行为干预与标准化指导 对有憩室炎病史的患者的纤维摄入量的影响。它还将扩展我们对炎症和 憩室炎发病机制并收集前瞻性收集的样本用于未来的生物标志物研究。最终， 鉴于憩室炎的患病率和发病率以及缺乏预测和预防措施， 确定经过验证的二级预防方法和风险生物标志物将改变治疗范式 改善数百万憩室炎患者的生活。