Polycystic Kidney Disease
Conditions
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.
Interventions
OTHERKetogenic Diet
The diet intervention will start after all baseline testing is complete
BIOLOGICALKetone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
BIOLOGICALCGM/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.
BIOLOGICALBlood Draw
Blood samples will be collected according to the schedule in Figure 1
OTHERBody Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
OTHERChange 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).
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Finger Stick Beta-Hydroxybutyrate | Up to ~ 52 Weeks | changes in fasting ketone levels. |
| Finger Stick Glucose | Up to ~ 52 Weeks | changes in fasting glucose levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMadison L Kackley, PhD
Backup ContactJeff Volek, PhD
Outcome results
None listed