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NCT Number: NCT06325644

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

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.

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Key information

Conditions

Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Finger Stick Beta-Hydroxybutyrate

    Time frame: Up to ~ 52 Weeks

    changes in fasting ketone levels.

  2. Finger Stick Glucose

    Time frame: Up to ~ 52 Weeks

    changes in fasting glucose levels.

Secondary outcomes

  1. Blood Pressure

    Time frame: Time Frame: Up to ~ 12 Weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeff Volek, PhD

CONTACT

[email protected]

6142926488

Madison L Kackley, PhD

CONTACT

[email protected]

6142479650

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 22, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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