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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Orange, California, United States
Torrance, California, United States
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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