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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-PR212399-G | Other Grant/Funding Number | Departent of Defense |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketogenic Diet | Other | The diet intervention will start after all baseline testing is complete |
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| Measure | Description | Time Frame |
|---|---|---|
| Finger Stick Beta-Hydroxybutyrate | changes in fasting ketone levels. | Up to ~ 52 Weeks |
| Finger Stick Glucose | changes in fasting glucose levels. | Up to ~ 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Time Frame: Up to ~ 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madison L Kackley, PhD | Contact | 6142479650 | kackley.19@osu.edu | |
| Jeff Volek, PhD | Contact | 6142926488 | volek.1@osu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 7, 2024 | Mar 19, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2024 | Mar 19, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| ID | Term |
|---|---|
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| D007659 | Ketones |
| D001800 | Blood Specimen Collection |
| D001823 | Body Composition |
| D005919 | Glomerular Filtration Rate |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Ketone/Glucose Monitoring | Biological | KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence. |
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| CGM/CKM | Biological | 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. |
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| Blood Draw | Biological | Blood samples will be collected according to the schedule in Figure 1 |
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| Body Composition | Other | DEXA Scanning will be done pre-, mid-, and post- intervention. |
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| 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). |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009930 | Organic Chemicals |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D001824 | Body Constitution |
| D007677 | Kidney Function Tests |
| D003950 | Diagnostic Techniques, Urological |
| D014553 | Urinary Tract Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |