Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease
Enrolling by invitation · Not applicable
Conditions studied: Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM), CKD Stage 3, CKD Stage 4, CKD Stage 5, Diabetes Mellitus, Diabetic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT05514184
- Run by
- University of California, Irvine
- People needed
- 120
- Starts
- 2023-10-01
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-07-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UCI — Orange, California, United States
- Harbor-UCLA/Lundquist — Torrance, California, United States
Full record on ClinicalTrials.gov
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