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Well-Formulated Ketogenic Diet Polycystic Kidney Disease

RecruitingNAAges 18 Years - 65 YearsAllOhio State University
NCT06325644 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Ketogenic Diet
  • Ketone/Glucose Monitoring
  • CGM/CKM
  • Blood Draw
  • Body Composition
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Where

1 site
The Ohio State University
Columbus, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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