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Search / Trial NCT05514184

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

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Aug 21, 2022

Trial Information

Current as of July 01, 2025

Enrolling by invitation

Keywords

Plant Dominant Low Protein (Plado) Diet Plant Focused Nutrition In Ckd/Dm (Plafond) Diet Plant Based Protein Glomerular Hyperfiltration High Protein Diet Potassium Restricted Diet Renal Disease Progression Pilot/Feasibility Randomized Controlled Trial Diet Adherence Meal Plans Renal Diet Veterans Animal Protein Continuous Glucose Monitoring (Cgm) Ckd Related Symptoms 24 Hour Urine Nitrogen Cystatin C And Associated E Gfr Dietary Education Medical Nutrition Therapy (Mnt) Uremic Symptoms

ClinConnect Summary

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 pr...

Gender

ALL

Eligibility criteria

  • 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.

About University Of California, Irvine

The University of California, Irvine (UCI) is a leading research institution renowned for its commitment to advancing health and medical knowledge through innovative clinical trials. With a robust infrastructure for clinical research, UCI fosters interdisciplinary collaboration among its esteemed faculty and researchers, aiming to translate scientific discoveries into effective therapeutic solutions. The university prioritizes ethical standards and participant safety while addressing critical healthcare challenges across various fields, including cancer, neurology, and public health. UCI's dedication to excellence in research and education positions it as a pivotal contributor to the advancement of clinical science and patient care.

Locations

Orange, California, United States

Torrance, California, United States

Patients applied

0 patients applied

Trial Officials

Kamyar Kalantar-Zadeh, MD, MPH, PhD

Principal Investigator

University of California

Connie M Rhee, MD, MS

Principal Investigator

University of California

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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