By InvitationNot Applicable

Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease

United States120 participantsStarted 2023-10-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Dietary adherence to PLAFOND vs. standard-of-care renal diet assessed by diet diaries

Timeframe: 6 months

Trial details

NCT IDNCT05514184

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-30