[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632129":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":30,"locations":39,"responsibleParty":61,"collaborators":29,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":29,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":29,"enrollmentInfo":72,"targetDuration":29,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":42,"whyStopped":29,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"AdventHealth","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Diet arm","EXPERIMENTAL","This is a whole food plant-based diet that excludes meat, dairy, eggs and oil",[13],"Other: Diet",{"label":15,"type":10,"description":16,"interventionNames":17},"medical managment","This approach reflects standard pharmacologic management of diabetic peripheral neuropathy. Commonly used medications include antiepileptic agents (gabapentin, pregabalin), serotonin-norepinephrine reuptake inhibitors (e.g., duloxetine), tricyclic antidepressants (e.g., amitriptyline, nortriptyline), and over-the-counter options such as alpha-lipoic acid and turmeric.",[18],"Other: Medical management",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Diet","Plant-based diet",[9],[22],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Medical management","Medication optimization",[15],null,[31,36],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"William J Beckworth, MD","CONTACT","828-654-8546","william.beckworth.md@adventhealth.com",{"name":37,"role":33,"phone":34,"phoneExt":29,"email":38},"Mary Stanford, Clinical Research Coordinator","mary.stanford@adventhealth.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"AdventHealth Hendersonville","RECRUITING","Hendersonville","North Carolina","28759","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-82.46095,35.31873,{"lat":52,"lon":51},[55,56,58],{"name":37,"role":33,"phone":34,"phoneExt":29,"email":38},{"name":32,"role":57,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"name":59,"role":60,"phone":29,"phoneExt":29,"email":29},"Sven Jonsson, MD","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100632129","the-treatment-of-painful-diabetic-neuropathy-with-diet-100632129",false,"NCT07509671","The Treatment of Painful Diabetic Neuropathy With Diet","The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial","Inclusion Criteria:\n\n* Definitive diagnosis of type II diabetes mellitus (HgA1c ≥ 6.5) or pre-diabetes (HgA1c 5.7-6.4)\n* objective documentation of peripheral neuropathy on EMG\u002FNCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less\n* presence of painful neuropathy in addition to decreased sensation\n* with pain rated ≥4\u002F10 on a 0-10 numerical rating scale (NRS)\n* age 18 years or older\n* ability to provide informed consent\n* ability to attend follow-up visits.\n\nExclusion Criteria:\n\n* Potential causes of neuropathy other than type II diabetes mellitus (as listed below)\n* type I diabetes\n* vitamin B12 deficiency\n* folate deficiency\n* thyroid dysfunction,\n* other nutritional deficiencies\n* autoimmune disorders\n* inflammatory disorders\n* HIV\u002FAIDS\n* exposure to metals or toxins\n* multiple myeloma,\n* moderate to severe lumbar stenosis with neurogenic claudication","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this clinical trial is to determine whether targeted nutritional changes can improve symptoms of painful diabetic neuropathy. Impaired blood flow to peripheral nerves-resulting in reduced oxygen delivery and subsequent nerve injury-is a well-established contributor to neuropathy. Prior studies have shown that a whole-food, plant-based diet without added oils can improve or even reverse arterial disease, suggesting a potential mechanism for enhancing nerve perfusion and function.\n\nThis study is a randomized controlled trial comparing a whole-food, plant-based diet with standard pharmacologic management for painful diabetic neuropathy.",[80,81,82],"Painful Diabetic Neuropathy (PDN)","Peripheral Neuropathy With Type 2 Diabetes","Vegan Diet",[84,85,86,87,88,89],"painful","diabetic","neuropathy","peripheral neuropathy","diabetes","diabetes type 2","2026-04-27",{"date":92,"type":93},"2026-04-30","ACTUAL",{"date":95,"type":93},"2024-04-23",{"date":97,"type":74},"2028-02-28",{"name":5,"class":6},1]