Well-Formulated Ketogenic Diet Polycystic Kidney Disease

The Ohio State University

Status

Enrolling

Conditions

Polycystic Kidney Disease

Treatments

Biological: CGM/CKM

Biological: Blood Draw

Other: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .

Biological: Ketone/Glucose Monitoring

Other: Body Composition

Other: Ketogenic Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06325644

2023H0258

CDMRP-PR212399-G (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Ketogenic Diet

Experimental group

Description:

The KD will follow general principles the investigators have described with the aim to achieve blood ketones \>0.5 mM, which will require most participants to consume \<50 g/day carbohydrate and \~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.