No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
20 (estimated)
Sponsor
Ohio State University · Other
Who this trial is looking for
This trial is looking for people with a specific type of kidney disease to see how a ketogenic diet affects their kidney function. Participants will follow this diet for a year and will undergo tests to monitor their health during the study.
Are You a Good Fit for This Trial?
Must not be takingTolvaptan
Rules you outSevere kidney diseaseDiabetesPregnancy
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with ADPKD.
My kidney function is adequate with a GFR of 25 mg/dl or higher.
I am considered at risk for my kidney disease getting worse.
I have not changed my medications in the last 3 months.
I can follow a specific diet plan.
I can sign informed consent.
You may not be able to join if
I am currently being treated with Tolvaptan.
I have diabetes.
I am pregnant.
I cannot have an MRI.
I have followed a ketogenic diet in the last 3 months.
I have severe kidney disease with a GFR less than 25 mg/dl.
I cannot buy food for the diet.
I have gastrointestinal disorders that would interfere with the diet.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Sta…
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.
Trial Locations
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Eligibility 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, urologi…
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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