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
Ohio State University
20 participants
Jun 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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
- No changes of medications within the last three months.
- Able to comply with dietary intervention
- Ability to sign informed consent
Exclusion Criteria9
- Patients currently being treated with Tolvaptan
- Diagnosed with diabetes.
- Pregnancy
- Contraindications to MRI
- Ketogenic diet within the last three months
- Severe kidney disease with GFR \< 25 mg/dl
- Unable to purchase food for the diet intervention
- Gastrointestinal disorders that will interfere with diet intervention
- Chronic alcohol or drug abuse
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Interventions
The diet intervention will start after all baseline testing is complete
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
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 samples will be collected according to the schedule in Figure 1
DEXA Scanning will be done pre-, mid-, and post- intervention.
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)
View Full Details on ClinicalTrials.gov
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NCT06325644