Well-Formulated Ketogenic Diet 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 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 Overview

• Status: Not yet recruiting
• Conditions: Polycystic Kidney Disease
• Intervention / Treatment: Other: Ketogenic Diet; Biological: Blood Draw; Biological: Ketone/Glucose Monitoring; Other: Body Composition; Biological: CGM/CKM; Other: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Madison L Kackley, PhD; Phone Number: 6142479650; Email: kackley.19@osu.edu
• Study Contact Backup: Name: Jeff Volek, PhD; Phone Number: 6142926488; Email: volek.1@osu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: Ketogenic Diet; The diet intervention will start after all baseline testing is complete; Biological: Blood Draw; Blood samples will be collected according to the schedule in Figure 1; Biological: Ketone/Glucose Monitoring; KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.; Other: Body Composition; DEXA Scanning will be done pre-, mid-, and post- intervention.; Biological: CGM/CKM; Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at ~2- week intervals during the study. The sensor will be removed at the end of the final test day.; Other: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .; Changes in glomerular filtration rate will be assessed via magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. Trained imaging professionals will analyze the images to determine overall change (mg/mmol).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Finger Stick Beta-Hydroxybutyrate	changes in fasting ketone levels.	Up to ~ 52 Weeks
Finger Stick Glucose	changes in fasting glucose levels.	Up to ~ 52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Changes in both Systolic and Diastolic blood pressure will be measured at each lab visit (eg. Baseline, Week 6, and Week 12). Recording: The systolic and diastolic pressures are recorded in millimeters of mercury (mmHg). For example, a reading of "120/80 mmHg" indicates a systolic pressure of 120 mmHg and a diastolic pressure of 80 mmHg.	Time Frame: Up to ~ 12 Weeks

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Polycystic Kidney Diseases
• Other Study ID Numbers: 2023H0258; CDMRP-PR212399-G (Other Grant/Funding Number: Departent of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No