Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Not Applicable

Recruiting

• Conditions: Polycystic Kidney Disease
• Interventions: Other: Ketogenic Diet; Biological: Ketone/Glucose Monitoring; Biological: CGM/CKM; Biological: Blood Draw; Other: Body Composition; Other: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .

• Registration Number: NCT06325644
• Lead Sponsor: Ohio State University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-22
• Status Verified: 2024-06
• Study Start: 2024-06-01
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2026-04-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketogenic Diet	Body Composition	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.
Ketogenic Diet	Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .	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.
Ketogenic Diet	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.
Ketogenic Diet	Ketone/Glucose Monitoring	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.
Ketogenic Diet	Blood Draw	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.
Ketogenic Diet	CGM/CKM	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.

Primary Outcome Measures

Name	Time	Method
Finger Stick Glucose	Up to ~ 52 Weeks	changes in fasting glucose levels.
Finger Stick Beta-Hydroxybutyrate	Up to ~ 52 Weeks	changes in fasting ketone levels.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure	Time Frame: Up to ~ 12 Weeks	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.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States