Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06325644
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic Diet — OTHER
    The diet intervention will start after all baseline testing is complete
  • Ketone/Glucose Monitoring — BIOLOGICAL
    KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
  • CGM/CKM — BIOLOGICAL
    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
    Blood samples will be collected according to the schedule in Figure 1
  • Body Composition — OTHER
    DEXA Scanning will be done pre-, mid-, and post- intervention.
  • Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) . — OTHER
    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).

Study Details

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.

Key Dates

Start date
Jun 1, 2024
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ketogenic Diet
    The KD will follow general principles the investigators have described with the aim to achieve blood ketones \>0.5 mM, which will require most participants to consume \<50 g/day carbohydrate and \~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.

Primary Outcome Measure

Finger Stick Beta-Hydroxybutyrate [ Time Frame: Up to ~ 52 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State UniversityColumbusOhio43210
Madison L Kackley, PhD
[email protected]
740-817-1622
Jeff Volek, PhD
[email protected]
6146881701

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By research site
The Ohio State University· Columbus, OH

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