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 慢性肾脏疾病（CKD）影响10-15％的美国成年人，包括30-40％的糖尿病患者 Mellitus（DM）与不良预后有关，并且通常会发展为需要透析或移植。 CKD的所有美国人中有一半也患有DM。虽然传统和新兴的药物治疗往往是 饮食干预措施的协同作用在糖尿病（CKD/DM）中用于CKD（CKD/DM） 检查。低碳水化合物低脂饮食通常在DM中建议使用，而低蛋白质饮食（LPD） 建议用于非糖尿病CKD，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导致肾小球过滤，并且 CKD/DM患者的肾功能下降速度更快。关于 在CKD/DM中，潜在风险与基于植物的饮食的好处，为此指南仍基于专家 观点。鉴于传统的DM管理饮食限制，人们担心以植物为基础 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大的 与非糖尿病患者相比，鉴于CKD/DM患者的CKD进展速度更快。 目前，临床实践指南提供了有关金额的相互矛盾的建议（低VS。 CKD/DM中饮食蛋白摄入量（DPI）的高源（植物与动物）。鉴于先前的饮食试验 CKD，例如1994年对肾脏疾病（MDRD）研究的修饰，不包括CKD/DM 检查植物与基于动物的蛋白的最佳比例 饮食干预研究，以检查CKD/DM中以患者为中心的植物性饮食的功效和安全性。 本着PAS 20-160的精神（针对NIDDK疾病的临床试验的小R01）我们提出了一个飞行员 可行性随机对照试验，与患者的常规随访访问并行进行 加利福尼亚大学欧文分校的诊所，以测试实施植物的可行性和安全性 - DPI为0.6-0.8 g/kg/d的CKD/DM（PLAFOND）饮食中的集中营养 来源，与护理标准的肾脏饮食，具有<1/3植物 - 源和低钾含量的饮食，由 营养师在120例CKD/DM阶段3-5患者的6个月内。我们将确定是否 Plafond Diet与护理标准肾脏饮食可以粘附在饮食中持续分离 蛋白质和植物性比例为3个月和6个月。我们还将检查营养状况，身体状况 使用传统指标和连续的性能和身体成分以及血糖措施 葡萄糖监测，而其他生化参数和患者报告的结果在内 还将研究症状。除了提供患者的必要可行性和安全数据外 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。