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Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Sponsor: Ohio State University
Summary
This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.
Official title: Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-06-01
Completion Date
2027-04-01
Last Updated
2025-09-26
Healthy Volunteers
No
Conditions
Interventions
Ketogenic Diet
The diet intervention will start after all baseline testing is complete
Ketone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
CGM/CKM
Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at \~2- week intervals during the study. The sensor will be removed at the end of the final test day.
Blood Draw
Blood samples will be collected according to the schedule in Figure 1
Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
Changes in glomerular filtration rate will be assessed via magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. Trained imaging professionals will analyze the images to determine overall change (mg/mmol).
Locations (1)
The Ohio State University
Columbus, Ohio, United States