Well-Formulated Ketogenic Diet Polycystic Kidney Disease
ConditionPolycystic Kidney Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOhio State University
About this trial
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.
Eligibility criteria
Qualifiers
Age 18-65 years old
Diagnosis of ADPKD by imaging and/or genetic testing
GFR ≥ 25 mg/dl
Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR, hypertension onset ≤ 35 years of age, urologic events ≤ 35 years of age, PKD 1 truncating mutation and PROPKD score of 4 or higher as determined by the treating physician
Disqualifiers
Patients currently being treated with Tolvaptan
Diagnosed with diabetes.
Pregnancy
Contraindications to MRI
Trial design
Treatments tested in this trial
- Ketogenic Diet
- Ketone/Glucose Monitoring
- CGM/CKM
- Blood Draw
- Body Composition
- Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov