[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541114":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":45,"locations":55,"responsibleParty":75,"collaborators":23,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":23,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":23,"overallStatus":58,"whyStopped":23,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Ohio State University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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 \\\u003C50 g\u002Fday carbohydrate and \\~1.5 g\u002Fkg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.",[13,14,15,16,17,18],"Other: Ketogenic Diet","Biological: Ketone\u002FGlucose Monitoring","Biological: CGM\u002FCKM","Biological: Blood Draw","Other: Body Composition","Other: Change in glomerular filtration rate (mg\u002Fmmol) via magnetic resonance imaging (MRI) .",[20,24,29,33,37,41],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"The diet intervention will start after all baseline testing is complete",[9],null,{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":23},"BIOLOGICAL","Ketone\u002FGlucose Monitoring","KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"CGM\u002FCKM","Continuous Ketone\u002FGlucose 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.",[9],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"Blood Draw","Blood samples will be collected according to the schedule in Figure 1",[9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":23},"Body Composition","DEXA Scanning will be done pre-, mid-, and post- intervention.",[9],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":23},"Change in glomerular filtration rate (mg\u002Fmmol) 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\u002Fmmol).",[9],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":23,"email":50},"Madison L Kackley, PhD","CONTACT","6142479650","kackley.19@osu.edu",{"name":52,"role":48,"phone":53,"phoneExt":23,"email":54},"Jeff Volek, PhD","6142926488","volek.1@osu.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"The Ohio State University","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-82.99879,39.96118,{"lat":68,"lon":67},[71,73],{"name":47,"role":48,"phone":72,"phoneExt":23,"email":50},"740-817-1622",{"name":52,"role":48,"phone":74,"phoneExt":23,"email":54},"6146881701",{"type":76,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100541114","well-formulated-ketogenic-diet-polycystic-kidney-disease-100541114",false,"NCT06325644","Well-Formulated Ketogenic Diet Polycystic Kidney Disease","Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression","Inclusion Criteria:\n\n* Age 18-65 years old\n* Diagnosis of ADPKD by imaging and\u002For genetic testing\n* GFR ≥ 25 mg\u002Fdl\n* 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\n* No changes of medications within the last three months.\n* Able to comply with dietary intervention\n* Ability to sign informed consent\n\nExclusion Criteria:\n\n* Patients currently being treated with Tolvaptan\n* Diagnosed with diabetes.\n* Pregnancy\n* Contraindications to MRI\n* Ketogenic diet within the last three months\n* Severe kidney disease with GFR \\\u003C 25 mg\u002Fdl\n* Unable to purchase food for the diet intervention\n* Gastrointestinal disorders that will interfere with diet intervention\n* Chronic alcohol or drug abuse","ALL","18 Years","65 Years",{"count":88,"type":89},20,"ESTIMATED","INTERVENTIONAL",[92],"NA","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.",[95],"Polycystic Kidney Disease","2026-05-12",{"date":98,"type":99},"2026-05-14","ACTUAL",{"date":101,"type":99},"2024-06-01",{"date":103,"type":89},"2027-04-01",{"name":5,"class":6},1]