Plant-Focused Nutrition in Patients with Diabetes and Chronic Kidney Disease (PLAFOND Study): A Pilot/Feasibility Study

糖尿病和慢性肾病患者的植物性营养（PLAFOND 研究）：试点/可行性研究

• 批准号: 10586677
• 负责人: Kamyar Kalantar-Zadeh
• 金额: $ 29.28万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-10 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586677
• 关键词: Acids; Adherence; Adult; Affect; American; Animals; Anthropometry; Biochemical; Blood Glucose; Body Composition; California; Carbohydrates; Chronic Kidney Failure; Clinic; Clinical; Clinical Practice Guideline; Clinical Trials; Collection; Continuous Glucose Monitor; Data; Diabetes Mellitus; Dialysis procedure; Diet; Diet Modification; Dietary Intervention; Dietary Proteins; Dietitian; Disease; Disease Progression; Energy Intake; Exclusion; Expert Opinion; Fat-Restricted Diet; Feasibility Studies; Foundations; Future; Glycosylated hemoglobin A; Guidelines; Hour; Hypertension; Intervention Studies; Kidney; Kidney Diseases; Kidney Failure; Lead; Malnutrition; Measurable; Measures; Multicenter Trials; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Nutritional; Nutritional status; Outcome; Patient Outcomes Assessments; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Physical Function; Physical Performance; Plant Sources; Plants; Potassium; Protein-Restricted Diet; Proteins; Public Health; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Renal function; Research; Risk; Role; Safety; Serum; Sodium-Restricted Diet; Source; Symptoms; Testing; Toxin; Transplantation; Universities; Uremia; Urine; Visit; base; compliance behavior; design; diabetes management; diaries; dietary; dietary restriction; efficacy evaluation; feasibility testing; flexibility; follow-up; frailty; hyperkalemia; indexing; multi-site trial; muscle strength; non-diabetic; nutrition; patient oriented; patient safety; post gamma-globulins; primary outcome; protein intake; recruit; response; safety and feasibility; satisfaction; secondary outcome; standard of care; wasting

SUMMARY Chronic kidney disease (CKD) affects 10-15% of US adults including 30-40% of persons with diabetes mellitus (DM), is associated with poor outcomes, and often progresses to requiring dialysis or transplantation. Half of all Americans with CKD also have DM. While traditional and emerging pharmacotherapies are often used in CKD with diabetes (CKD/DM), the synergistic role of dietary interventions has not been well examined. Low-carbohydrate low-fat diets are often recommended in DM, whereas low-protein diets (LPDs) are recommended for non-diabetic CKD with increasing emphasis on plant-based protein sources. Evidence suggests that high-protein diets with greater animal protein content may lead to glomerular hyperfiltration and faster decline in renal function in patients with CKD/DM. There remains major controversy regarding the potential risks vs. benefits of plant-based diets in CKD/DM, for which guidelines remain based on expert opinion. Given conventional dietary restrictions for the management of DM, there is concern that plant-based LPDs may lead to protein-energy wasting and hyperkalemia, whereas these diets may indeed be most beneficial in patients with CKD/DM given their faster rates of CKD progression as compared to non-diabetics. At present, clinical practice guidelines provide conflicting recommendations regarding the amount (low vs. high) and source (plant vs. animal) of dietary protein intake (DPI) in CKD/DM. Given that prior dietary trials in CKD such as the 1994 Modification of Diet in Renal Disease (MDRD) study excluded CKD/DM and did not examine the optimal proportion of plant vs. animal-based proteins, there is urgent unmet need for a rigorous dietary intervention study to examine the efficacy and safety of patient-centered plant-based diets in CKD/DM. In the spirit of PAS 20-160 (Small R01s for Clinical Trials Targeting NIDDK Diseases) we propose a pilot feasibility randomized controlled trial, conducted in parallel with patients' routine follow-up visits at two CKD clinics within the University of California Irvine, to test the feasibility and safety of implementing a Plant- Focused Nutrition in CKD/DM (PLAFOND) diet with a DPI of 0.6-0.8 g/kg/d comprised of >2/3 plant-based sources, vs. standard-of-care renal diet with <1/3 plant-sources and low-potassium content, administrated by dietitians, over a 6-month period in 120 patients with CKD/DM stage 3-5. We will determine whether the PLAFOND diet vs. the standard-of-care renal diet can be adhered to with consistent separation in dietary protein and plant-based proportions at 3- and 6-months. We will also examine nutritional status, physical performance, and body composition, as well as glycemic measures using traditional metrics and continuous glucose monitoring, while other biochemical parameters and patient-reported outcomes including CKD-related symptoms will also be studied. In addition to providing the requisite feasibility and safety data of patient- centered dietary regimens needed for the design and conduct of future multi-center trials, our proposed study will have major immediate impact by reinvigorating the critical role of dietary management of CKD/DM.

总结 慢性肾脏疾病（CKD）影响10-15%的美国成年人，包括30-40%的糖尿病患者 糖尿病（DM）与不良结局相关，并且通常进展为需要透析或移植。 所有患有CKD的美国人中有一半也患有DM。虽然传统和新兴的药物疗法往往 用于CKD合并糖尿病（CKD/DM），饮食干预的协同作用并不好 考察低碳水化合物低脂饮食通常被推荐用于DM，而低蛋白饮食（LPD） 推荐用于非糖尿病CKD，并越来越强调植物性蛋白质来源。证据 提示高蛋白饮食中动物蛋白含量较高可能导致肾小球超滤， CKD/DM患者肾功能下降更快。关于这一点，仍然存在重大争议。 CKD/DM中植物性饮食的潜在风险与益处，指南仍然基于专家 意见鉴于传统的饮食限制管理DM，有人担心，植物性的， LPD可能导致蛋白质能量浪费和高钾血症，而这些饮食确实可能是最重要的。 与非糖尿病患者相比，CKD/DM患者的CKD进展速度更快。 目前，临床实践指南提供了关于量的相互矛盾的建议（低vs. 高）和来源（植物与动物）膳食蛋白质摄入量（DPI）。鉴于之前的饮食试验 CKD，如1994年肾脏疾病饮食改良（MDRD）研究排除了CKD/DM， 研究植物与动物蛋白质的最佳比例，迫切需要一个严格的 饮食干预研究，以检查以患者为中心的植物性饮食在CKD/DM中的有效性和安全性。 根据PAS 20-160（针对NIDDK疾病的临床试验的小型R 01）的精神，我们提出了一个试点 可行性随机对照试验，与两次CKD患者常规随访同时进行 加州尔湾大学的诊所，以测试实施工厂的可行性和安全性- CKD/DM（PLAFOND）饮食中的重点营养，DPI为0.6-0.8 g/kg/d，由>2/3的植物性成分组成 来源，与标准护理肾脏饮食（<1/3植物来源和低钾含量）相比， 营养师，在120例CKD/DM 3-5期患者中进行了为期6个月的研究。我们将决定是否 PLAFOND饮食与标准治疗肾脏饮食可以坚持饮食中的一致分离 蛋白质和植物为基础的比例在3个月和6个月。我们还将检查营养状况，身体状况， 性能和身体成分，以及使用传统指标和连续血糖测量 血糖监测，而其他生化参数和患者报告的结果，包括CKD相关 还将研究症状。除了提供必要的患者可行性和安全性数据外， 为设计和进行未来的多中心试验，我们提出的研究， 将通过重振饮食管理在CKD/DM中的关键作用而产生重大的直接影响。