NCT05514184
Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease
Enrolling by Invitation
NAAges 18+InterventionalTreatmentUniversity of California, IrvineInvestigator-initiated
~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
Where it's being run
2 sites across 1 statesCalifornia2
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
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
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.