Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05514184
Other study ID # 1750
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date September 30, 2026

Study information

Verified date June 2023
Source University of California, Irvine
Contact Kamyar Kalantar-Zadeh, MD, MPH, PhD
Phone 562-999-4224
Email kkz@uci.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 this study, the investigators will determine whether the plant-focused diet intervention is feasible for patient adherence, whether this diet is safe by avoiding malnutrition, frailty, and high potassium or glucose blood levels, and whether patient reported outcomes are favorably impacted.


Description:

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. The investigators will conduct a pilot feasibility randomized controlled trial in parallel with patients' routine follow-up visits at ambulatory clinics 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. The investigators 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. The investigators 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-conduct of future multi-center trials, this study will have major immediate impact by reinvigorating the critical role of dietary management of CKD/DM.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date September 30, 2026
Est. primary completion date March 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Dietary Supplement:
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of California, Irvine VA Long Beach Healthcare System

References & Publications (8)

Kalantar-Zadeh K, Fouque D. Nutritional Management of Chronic Kidney Disease. N Engl J Med. 2017 Nov 2;377(18):1765-1776. doi: 10.1056/NEJMra1700312. No abstract available. — View Citation

Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24. — View Citation

Kalantar-Zadeh K, Joshi S, Schlueter R, Cooke J, Brown-Tortorici A, Donnelly M, Schulman S, Lau WL, Rhee CM, Streja E, Tantisattamo E, Ferrey AJ, Hanna R, Chen JLT, Malik S, Nguyen DV, Crowley ST, Kovesdy CP. Plant-Dominant Low-Protein Diet for Conservative Management of Chronic Kidney Disease. Nutrients. 2020 Jun 29;12(7):1931. doi: 10.3390/nu12071931. — View Citation

Kalantar-Zadeh K, Mattix-Kramer HJ, Moore LW. Culinary Medicine as a Core Component of the Medical Nutrition Therapy for Kidney Health and Disease. J Ren Nutr. 2021 Jan;31(1):1-4. doi: 10.1053/j.jrn.2020.11.002. No abstract available. — View Citation

Kalantar-Zadeh K, Rhee CM, Joshi S, Brown-Tortorici A, Kramer HM. Medical nutrition therapy using plant-focused low-protein meal plans for management of chronic kidney disease in diabetes. Curr Opin Nephrol Hypertens. 2022 Jan 1;31(1):26-35. doi: 10.1097/MNH.0000000000000761. — View Citation

Kalantar-Zadeh K, Saville J, Moore LW. Unleashing the Power of Renal Nutrition in Value-Based Models of Kidney Care Choices: Leveraging Dietitians' Expertise and Medical Nutrition Therapy to Delay Dialysis Initiation. J Ren Nutr. 2022 Jul;32(4):367-370. doi: 10.1053/j.jrn.2022.05.001. Epub 2022 May 16. No abstract available. — View Citation

Kistler BM, Moore LW, Benner D, Biruete A, Boaz M, Brunori G, Chen J, Drechsler C, Guebre-Egziabher F, Hensley MK, Iseki K, Kovesdy CP, Kuhlmann MK, Saxena A, Wee PT, Brown-Tortorici A, Garibotto G, Price SR, Yee-Moon Wang A, Kalantar-Zadeh K. The International Society of Renal Nutrition and Metabolism Commentary on the National Kidney Foundation and Academy of Nutrition and Dietetics KDOQI Clinical Practice Guideline for Nutrition in Chronic Kidney Disease. J Ren Nutr. 2021 Mar;31(2):116-120.e1. doi: 10.1053/j.jrn.2020.05.002. Epub 2020 Jul 29. — View Citation

Rhee CM, Kalantar-Zadeh K, Moore LW. Medical Nutrition Therapy for Diabetic Kidney Disease. J Ren Nutr. 2021 May;31(3):229-232. doi: 10.1053/j.jrn.2021.03.004. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT03743779 - Mastering Diabetes Pilot Study
Completed NCT03786978 - Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus N/A
Completed NCT01804803 - DIgital Assisted MONitoring for DiabeteS - I N/A
Completed NCT05039970 - A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT04068272 - Safety of Bosentan in Type II Diabetic Patients Phase 1
Completed NCT03243383 - Readmission Prevention Pilot Trial in Diabetes Patients N/A
Completed NCT03730480 - User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS) N/A
Recruiting NCT02690467 - Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm. N/A
Completed NCT02229383 - Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus Phase 3
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Completed NCT06181721 - Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes N/A
Recruiting NCT04489043 - Exercise, Prediabetes and Diabetes After Renal Transplantation. N/A
Withdrawn NCT03319784 - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients Phase 4
Completed NCT03542084 - Endocrinology Auto-Triggered e-Consults N/A
Completed NCT02229396 - Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo Phase 3
Recruiting NCT05544266 - Rare and Atypical Diabetes Network
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Completed NCT05031000 - Blood Glucose Monitoring Systems: Discounter Versus Brand N/A
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A