Effect of a Ketogenic Diet on Polycystic Kidney Disease
Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
This study is testing if following a ketogenic diet for a year can help people with polycystic kidney disease keep their kidneys healthier and slow down the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06325644 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a ketogenic diet on patients with autosomal dominant polycystic kidney disease (ADPKD) who are at high risk for progression to end-stage renal disease (ESRD). It is a prospective, single-center study involving 20 participants who will undergo MRI and various blood and urinary tests at baseline, 6 months, and 52 weeks. The ketogenic diet will be followed for a year, with monitoring of ketone and glucose levels, and the investigatory diet team will provide support throughout the intervention. The goal is to assess changes in kidney volume, glomerular filtration rate (GFR), and microalbuminuria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of ADPKD and specific risk factors for rapid disease progression.
Not a fit: Patients currently treated with Tolvaptan, those with diabetes, or severe kidney disease (GFR < 25 mg/dl) may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a dietary intervention that slows the progression of kidney disease in patients with ADPKD.
How similar studies have performed: While dietary interventions in kidney disease are being explored, this specific approach using a ketogenic diet in ADPKD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Columbus, Ohio
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Madison L Kackley, PhD
- Email: kackley.19@osu.edu
- Phone: 6142479650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.