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El ensayo clínico NCT05514184 (PLAFOND) para Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), ERC estadio 3, ERC estadio 4, ERC estadio 5, Diabetes mellitus, Enfermedad renal diabética está reclutamiento por invitación. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Universidad de California en IrvinePlant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease (PLAFOND) 120 Dietético
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El ensayo clínico NCT05514184 (PLAFOND) es un estudio intervencionista para Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), ERC estadio 3, ERC estadio 4, ERC estadio 5, Diabetes mellitus, Enfermedad renal diabética. Su estado actual es: reclutamiento por invitación. El estudio se inició el 1 de octubre de 2023, con el objetivo de reclutar a 120 participantes. Dirigido por la Universidad de California en Irvine, se espera que finalice el 30 de septiembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 3 de julio de 2024.
Resumen
In this pilot clinical trial, the investigators will recruit and randomize 120 patients with diabetes mellitus and chronic kidney disease (CKD/DM) stages 3 to 5 to a patient-centered and flexible Plant-Focused Nutrition in Diabetes (PLAFOND) diet with >2/3 plant-based sources, which will be compared with a standard-of-care CKD diet, which is usually a low-potassium and low-salt diet, over a 6-month period. Through t...Mostrar más
Descripción detallada
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 exami...Mostrar más
Título oficial
Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease (PLAFOND Study): A Pilot/Feasibility Study
Condiciones médicas
Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)ERC estadio 3ERC estadio 4ERC estadio 5Diabetes mellitusEnfermedad renal diabéticaPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- PLAFOND
- 1750
Número del NCT
Inicio del estudio (real)
2023-10-01
Última actualización
2024-07-03
Fecha de finalización (estimada)
2026-09-30
Inscripción (prevista)
120
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutamiento por invitación
Palabras clave
plant-dominant low protein (PLADO) diet
plant-focused nutrition in CKD/DM (PLAFOND) diet
plant-based protein
glomerular hyperfiltration
high-protein diet
potassium restricted diet
renal disease progression
pilot/feasibility randomized controlled trial
diet adherence
meal plans
renal diet
Veterans
animal protein
continuous glucose monitoring (CGM)
CKD-related symptoms
24-hour urine nitrogen
Cystatin C and associated eGFR
dietary education
Medical Nutrition Therapy (MNT)
uremic symptoms
plant-focused nutrition in CKD/DM (PLAFOND) diet
plant-based protein
glomerular hyperfiltration
high-protein diet
potassium restricted diet
renal disease progression
pilot/feasibility randomized controlled trial
diet adherence
meal plans
renal diet
Veterans
animal protein
continuous glucose monitoring (CGM)
CKD-related symptoms
24-hour urine nitrogen
Cystatin C and associated eGFR
dietary education
Medical Nutrition Therapy (MNT)
uremic symptoms
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalPlant-focused low-protein nutrition in diabetic CKD (PLAFOND) Participants randomized to this arm will receive PLAFOND dietary intervention consisting of a flexible low-protein meal plan including 0.6-0.8 g/kg/day dietary protein with \>2/3% of the protein from plant-based sources, and the meal plan will be supported by dietitian who will provide dietary education and counseling to patients assigned to this arm. | PLAFOND diet PLAFOND is a pragmatic patient-centered dietary intervention supported by dietitians who provide education and counseling in the form of Medical Nutrition Therapy (MNT) consisting of 0.6-0.8 g/kg/day dietary protein with \>2/3% of the protein from plant-proteins. |
Comparador activoStandard-of-care renal diet (control group) Participants randomized to the control group will receive standard-of-care renal diet with low-potassium content based on dietitian counseling and guidance. | PLAFOND diet PLAFOND is a pragmatic patient-centered dietary intervention supported by dietitians who provide education and counseling in the form of Medical Nutrition Therapy (MNT) consisting of 0.6-0.8 g/kg/day dietary protein with \>2/3% of the protein from plant-proteins. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Dietary adherence to PLAFOND vs. standard-of-care renal diet assessed by diet diaries | Dietary Adherence including separation in dietary plant-based proportions of \>2/3 vs \<1/3 at 3- and 6-months will be ascertained by 3-day diet diaries in all 120 participants as the primary outcome. | 6 months |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Dietary adherence to PLAFOND vs. standard-of-care low-potassium renal diet assessed by 24-hour urine collections | Dietary Adherence and separation in dietary components of PLAFOND (plant-based proportions of protein \>2/3) vs. low-potassium renal diet (\<1/3 plant-based protein) at 3- and 6-months ascertained by and 24-hour urine collections (secondary outcome) | 6 months |
Physical function measured by Short Physical Performance Battery (SPPB) | Under "Nutritional and Physical Performance and Body Composition" physical function will be measured by Short Physical Performance Battery (SPPB), a value between 0 to 12 (higher suggesting more frail phenotype), at baseline, 3-, and 6-months. | 6 months |
Physical function measured by Fried Frailty Index | Under "Nutritional and Physical Performance and Body Composition" physical function will be measured by Fried Frailty Index, a score between 0 and 5, devided into ranking categories of non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5), measured at baseline, 3-, and 6-months. | 6 months |
Muscle strength measured by handgrip strength | Under the "Nutritional and Physical Performance and Body Composition", muscle strength will be measured by handgrip strength using dynamometer, scored using force production in kilograms (0-90), at baseline, 3-, and 6-months. | 6 months |
Body composition using caliper anthropometry to measure mid-arm muscle circumference (MAMC) | Under "Nutritional and Physical Performance and Body Composition", body composition will be assessed using caliper anthropometry to measure mid-arm muscle circumference (MAMC) in cm (\<12.5 cm as malnutrition), at baseline, 3-, and 6-months. | 6 months |
Body composition using near-infrared interactance | Under "Nutritional and Physical Performance and Body Composition", body composition will be assessed using caliper anthropometry and near-infrared interactance, producing percentage of body fat (unit: %), at baseline, 3-, and 6-months. | 6 months |
Biochemical parameter: serum A1c | Under "Glycemic, Renal and Safety Endpoints", biochemical parameter hemoglobin A1c, a value in percentage (normal rnage \<5.5%), will be measured at baseline, and 1-, 3- and 6-months in all 120 participants | 6 months |
Biochemical parameter: serum potassium | Under "Glycemic, Renal and Safety Endpoints", biochemical parameter serum potassium, a valie in mEq/L (normal range: 3.5-5.3 mEq/L), will be measured at baseline, and 1-, 3- and 6-months in all 120 participants | 6 months |
Biochemical parameter: serum Cystatin C | Under "Glycemic, Renal and Safety Endpoints", biochemical parameter serum Cystatin C (mg/L) will be measured at baseline, and 1-, 3- and 6-months in all 120 participants | 6 months |
Biochemical parameter: urinary albumin to creatinine ratio (ACR) | Under "Glycemic, Renal and Safety Endpoints", biochemical parameters including hemoglobin A1c, potassium, and Cystatin C and albumin to creatinine ratio (ACR) in mg/g will be measured at baseline, and 1-, 3- and 6-months in all 120 participants | 6 months |
Glycemic status by continuous glucose monitoring (GCM) | Under "Glycemic Endpoints", glycemic status ascertained by continuous glucose monitoring (CGM) via DEXCOM will be examined in a substudy of 50 patients at baseline and at 6-months. | 6 months |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
- Adult outpatient (>18 years old) with diabetes mellitus (DM), who attends ambulatory clinics in one of the two centers, who has the established diagnosis of stage 3-5 CKD and DM regardless of degree of proteinuria, and who wishes to prevent or delay dialysis initiation, is qualified, as long as there are at least 2 eGFRs <60 ml/min/1.73m2 three months apart with no intervening higher eGFR values.
- Participants will agree to follow the dietary instructions based on the randomization assignment and attend baseline visits as well as three additional ambulatory visits on Month 1, 3 and 6 post-randomization in person or via telehealth and respond to monthly or more frequent phone calls.
- Having a terminal illness with a life expectancy <6 months such as stage 4 metastatic cancer.
- Patients with any serum potassium >5.5 mEq/L during the 6 months preceding the screening visit.
Universidad de California en Irvine158 estudios activos para explorarVA Long Beach Healthcare SystemParte responsable del estudio
Kamyar Kalantar-Zadeh, Investigador principal, Professor of Medicine, University of California, Irvine
No hay datos de contacto.
2 Centros del estudio en 1 países
California
UCI, Orange, California, 92868-3217, United States
Harbor-UCLA/Lundquist, Torrance, California, 90502-2004, United States