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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Ketogenic Diet

    Other intervention

    The diet intervention will start after all baseline testing is complete

  • Ketone/Glucose Monitoring

    Biological/Vaccine

    KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.

  • CGM/CKM

    Biological/Vaccine

    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 Draw

    Biological/Vaccine

    Blood samples will be collected according to the schedule in Figure 1

  • Body Composition

    Other intervention

    DEXA Scanning will be done pre-, mid-, and post- intervention.

  • Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .

    Other 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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Ketogenic DietExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Finger Stick Beta-Hydroxybutyrate

changes in fasting ketone levels.

Time frame
Up to ~ 52 Weeks
2

Finger Stick Glucose

changes in fasting glucose levels.

Time frame
Up to ~ 52 Weeks

Secondary outcomes

1

Blood Pressure

Changes in both Systolic and Diastolic blood pressure will be measured at each lab visit (eg. Baseline, Week 6, and Week 12). Recording: The systolic and diastolic pressures are recorded in millimeters of mercury (mmHg). For example, a reading of "120/80 mmHg" indicates a systolic pressure of 120 mmHg and a diastolic pressure of 80 mmHg.

Time frame
Time Frame: Up to ~ 12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University

Lead sponsor

Source ClinicalTrials.gov
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