Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Polycystic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325644
• Other study ID #: 2023H0258
• Secondary ID: CDMRP-PR212399-G
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2027

Study information

• Verified date: March 2024
• Source: Ohio State University
• Contact: Madison L Kackley, PhD
• Phone: 6142479650
• Email: kackley.19[@]osu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney Disease
• Polycystic Kidney Diseases

Intervention

Other:
• Ketogenic Diet
The diet intervention will start after all baseline testing is complete

Biological:
• Ketone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
• 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.
• Blood Draw
Blood samples will be collected according to the schedule in Figure 1

Other:
• Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finger Stick Beta-Hydroxybutyrate	changes in fasting ketone levels.	Up to ~ 52 Weeks
Primary	Finger Stick Glucose	changes in fasting glucose levels.	Up to ~ 52 Weeks
Secondary	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