Polycystic Kidney DiseaseNCT06325644
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
A study testing Ketogenic Diet, Ketone/Glucose Monitoring and CGM/CKM in people with Polycystic Kidney Disease, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Polycystic Kidney Disease
- What is being tested?
- Ketogenic Diet, Ketone/Glucose Monitoring and CGM/CKM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Unable to purchase food for the diet intervention
- Gastrointestinal disorders that will interfere with diet intervention
- Chronic alcohol or drug abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Madison L Kackley, PhD, 740-817-1622, kackley.19@osu.edu
Jeff Volek, PhD, 6146881701, volek.1@osu.edu
About this study
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
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.
- Conditions
- Polycystic Kidney Disease
- Being tested
- Ketogenic Diet, Ketone/Glucose Monitoring, CGM/CKM, Blood Draw, Body Composition
- Medical subject headings
- Polycystic Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
The diet intervention will start after all baseline testing is complete
Ketone/Glucose MonitoringBiological
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
CGM/CKMBiological
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 DrawBiological
Blood samples will be collected according to the schedule in Figure 1
Body CompositionOther
DEXA Scanning will be done pre-, mid-, and post- intervention.
Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .Other
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).
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | 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. Receives: 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) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger Stick Beta-Hydroxybutyrate
changes in fasting ketone levels.
Measured: Up to ~ 52 Weeks
Finger Stick Glucose
changes in fasting glucose levels.
Measured: Up to ~ 52 Weeks
Secondary outcomes (1)
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.
Measured: Time Frame: Up to ~ 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325644
- Sponsor's protocol ID
- 2023H0258
- Other IDs
- CDMRP-PR212399-G
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06325644
- Acronym / sponsor ID
- 2023H0258
- Conditions
- Polycystic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | 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) .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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- Patients currently being treated with Tolvaptan
- Diagnosed with diabetes.
- Pregnancy
- Contraindications to MRI
- Ketogenic diet within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic DietThe diet intervention will start after all baseline testing is complete | Other | Ketogenic Diet |
| Ketone/Glucose MonitoringKetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence. | Biological | Ketogenic Diet |
| CGM/CKMContinuous 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 | Ketogenic Diet |
| Blood DrawBlood samples will be collected according to the schedule in Figure 1 | Biological | Ketogenic Diet |
| Body CompositionDEXA Scanning will be done pre-, mid-, and post- intervention. | Other | Ketogenic Diet |
| 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). | Other | Ketogenic Diet |
Primary outcome
Finger Stick Beta-Hydroxybutyrate
Time frame: Up to ~ 52 Weeks
changes in fasting ketone levels.
Finger Stick Glucose
Time frame: Up to ~ 52 Weeks
changes in fasting glucose levels.
1 secondary outcome
Blood Pressure
Time frame: Time Frame: Up to ~ 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet, Ketone/Glucose Monitoring and CGM/CKM in people with Polycystic Kidney Disease, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison L Kackley, PhD (6142479650, kackley.19@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finger Stick Beta-Hydroxybutyrate (time frame: Up to ~ 52 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.