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Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
The Ohio State University
Columbus, Ohio, United States
Start Date
June 1, 2024
Primary Completion Date
April 1, 2026
Completion Date
April 1, 2027
Last Updated
September 26, 2025
20
ESTIMATED participants
Ketogenic Diet
OTHER
Ketone/Glucose Monitoring
BIOLOGICAL
CGM/CKM
BIOLOGICAL
Blood Draw
BIOLOGICAL
Body Composition
OTHER
Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
OTHER
Lead Sponsor
Ohio State University
NCT07454174
NCT06867471
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04039061