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

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
The Ohio State University
RECRUITING
Columbus
Contact Information
Primary
Madison L Kackley, PhD
kackley.19@osu.edu
6142479650
Backup
Jeff Volek, PhD
volek.1@osu.edu
6142926488
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 20
Treatments
Experimental: Ketogenic Diet
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.
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov