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Well-Formulated Ketogenic Diet Polycystic Kidney Disease

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ClinicalTrials.gov Identifier: NCT06325644
Recruitment Status : Not yet recruiting
First Posted : March 22, 2024
Last Update Posted : March 22, 2024
Sponsor:
Information provided by (Responsible Party):
Ohio State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Polycystic Kidney Disease 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) . Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Estimated Study Start Date : April 1, 2024
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : April 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Finger Stick Beta-Hydroxybutyrate [ Time Frame: Up to ~ 52 Weeks ]
    changes in fasting ketone levels.

  2. Finger Stick Glucose [ Time Frame: Up to ~ 52 Weeks ]
    changes in fasting glucose levels.


Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06325644


Contacts
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Contact: Madison L Kackley, PhD 6142479650 kackley.19@osu.edu
Contact: Jeff Volek, PhD 6142926488 volek.1@osu.edu

Sponsors and Collaborators
Ohio State University
  Study Documents (Full-Text)

Documents provided by Ohio State University:
Study Protocol  [PDF] January 7, 2024
Informed Consent Form  [PDF] January 7, 2024

More Information
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Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT06325644    
Other Study ID Numbers: 2023H0258
CDMRP-PR212399-G ( Other Grant/Funding Number: Departent of Defense )
First Posted: March 22, 2024    Key Record Dates
Last Update Posted: March 22, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Kidney Diseases, Cystic
Genetic Diseases, Inborn
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies