Trials Today

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Purpose

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.

Condition

Polycystic Kidney Disease

Eligibility

Eligible Ages: Between 18 Years and 65 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

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

Arm Groups

Arm	Description	Assigned Intervention
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: Ketone/Glucose Monitoring KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence. 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. Biological: 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. 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).

Recruiting Locations

The Ohio State University
Columbus, Ohio 43210

Contact:
Madison L Kackley, PhD
740-817-1622
kackley.19@osu.edu

More Details

NCT ID: NCT06325644
Status: Recruiting
Sponsor: Ohio State University

Study Contact

Madison L Kackley, PhD
6142479650
kackley.19@osu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.