NCT06325644

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Kidney Disease

Interventions

Type	Name	Description
OTHER	Ketogenic Diet	The diet intervention will start after all baseline testing is complete
BIOLOGICAL	Ketone/Glucose Monitoring	KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
BIOLOGICAL	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.
BIOLOGICAL	Blood Draw	Blood samples will be collected according to the schedule in Figure 1
OTHER	Body Composition	DEXA Scanning will be done pre-, mid-, and post- intervention.
OTHER	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).

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2024-03-22
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States