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

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.

CT.gov Identifier
NCT06325644
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Ohio State University
Collaborator
N/A
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Drug
Blood draw
See More
Ketone/Glucose Monitoring
CGM/CKM
Genes
PKD1
GANAB
Study Dates
Jun 2024 - Apr 2026
Sex
Female & Male
Age
18 - 65 Years
Inclusion and Exclusion Criteria
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

Protocol Summary

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.

Study Locations

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