Well-Formulated Ketogenic Diet Polycystic Kidney Disease

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

Overview

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.

Interventions

• 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).

Primary outcome measures

• Finger Stick Beta-Hydroxybutyrate [Time frame: Up to ~ 52 Weeks]
• Finger Stick Glucose [Time frame: Up to ~ 52 Weeks]

Secondary outcome measures (1)

• Blood Pressure [Time frame: Time Frame: Up to ~ 12 Weeks]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• The Ohio State University — Columbus

Identifiers

NCT: NCT06325644 · 2023H0258 · CDMRP-PR212399-G

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗