Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06325644

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Led by Ohio State University · Updated on 2026-05-14

20

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years old
  • Diagnosis of ADPKD by imaging and/or genetic testing
  • Glomerular filtration rate (GFR) 65 25 mg/dl
  • At risk for rapid progression of ADPKD: Mayo Class 1C-1E with other high risk features such as early decline in GFR, hypertension onset 1 35 years, urologic events 1 35 years, PKD 1 truncating mutation, or PROPKD score 64
  • No medication changes in the last three months
  • Able to comply with the ketogenic diet
  • Able to sign informed consent
Not Eligible

You will not qualify if you...

  • Currently treated with Tolvaptan
  • Diagnosed with diabetes
  • Pregnant
  • Contraindications to MRI
  • Used ketogenic diet in the last three months
  • Severe kidney disease with GFR < 25 mg/dl
  • Unable to purchase food for the diet
  • Gastrointestinal disorders interfering with diet
  • Chronic alcohol or drug abuse

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

M

Madison L Kackley, PhD

CONTACT

J

Jeff Volek, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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