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.

概括 慢性肾病 (CKD) 影响着 10-15% 的美国成年人，其中包括 30-40% 的糖尿病患者 糖尿病 (DM) 与不良预后相关，并且常常进展到需要透析或移植。 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通常 用于慢性肾病合并糖尿病（CKD/DM）时，饮食干预的协同作用尚未得到很好的证实 检查了。糖尿病患者通常推荐低碳水化合物低脂肪饮食，而低蛋白饮食 (LPD) 推荐用于非糖尿病 CKD，并越来越重视植物性蛋白质来源。证据 表明动物蛋白含量较高的高蛋白饮食可能会导致肾小球过度滤过， CKD/DM 患者肾功能下降更快。仍存在重大争议 CKD/DM 中植物性饮食的潜在风险与益处，其指南仍基于专家 观点。鉴于治疗糖尿病的传统饮食限制，人们担心植物性饮食 LPD 可能会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有效的。 对 CKD/DM 患者有益，因为与非糖尿病患者相比，他们的 CKD 进展速度更快。 目前，临床实践指南就用量提供了相互矛盾的建议（低与高）。 CKD/DM 中膳食蛋白质摄入量 (DPI) 的高）和来源（植物与动物）。鉴于之前的饮食试验 CKD，例如 1994 年肾病饮食改良 (MDRD) 研究排除了 CKD/DM，并且没有 检查植物蛋白与动物蛋白的最佳比例，迫切需要严格的未满足的需求 膳食干预研究旨在检验以患者为中心的植物性饮食在 CKD/DM 中的有效性和安全性。 本着 PAS 20-160（针对 NIDDK 疾病的临床试验的小型 R01）的精神，我们提议进行试点 可行性随机对照试验，与两次 CKD 患者的常规随访并行进行 加州大学欧文分校内的诊所，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，包含 >2/3 的植物性饮食 来源，与<1/3植物来源和低钾含量的标准护理肾脏饮食，由 营养师对 120 名 CKD/DM 3-5 期患者进行了 6 个月的研究。我们将确定是否 PLAFOND 饮食与标准肾脏饮食的比较可以遵循饮食中的一致分离 3 个月和 6 个月时的蛋白质和植物性比例。我们还会检查营养状况、身体状况 表现、身体成分以及使用传统指标和连续指标的血糖测量 血糖监测，而其他生化参数和患者报告的结果，包括 CKD 相关的结果 还将研究症状。除了提供必要的可行性和安全性数据外， 设计和进行未来多中心试验所需的集中饮食方案，我们提出的研究 通过重振 CKD/DM 饮食管理的关键作用，将产生重大的直接影响。