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NCT05514184

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

Enrolling by Invitation
NAAges 18+InterventionalTreatment
University of California, Irvine
~120 participants
Updated 2024-07-03 on ClinicalTrials.gov
What's tested:PLAFOND diet

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dietary adherence to PLAFOND vs. standard-of-care renal diet assessed by diet diaries
Measured over 6 months

Conditions

Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
CKD Stage 3
CKD Stage 4
CKD Stage 5
Diabetes Mellitus
Diabetic Kidney Disease

Explore related trials

Chronic Kidney DiseaseDiabetes MellitusDiabetic Nephropathy

NCT05514184

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Harbor-UCLA/Lundquist

    Torrance, Californiano site contact published

  • UCI

    Orange, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kamyar Kalantar-Zadeh, MD, MPH, PhD · PRINCIPAL_INVESTIGATOR · University of California
  • Connie M Rhee, MD, MS · PRINCIPAL_INVESTIGATOR · University of California

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Dietary adherence to PLAFOND vs. standard-of-care renal diet assessed by diet diaries6 months

    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.