[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483243":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":34,"studyPopulation":26,"armGroups":35,"interventions":42,"overallOfficials":50,"centralContacts":54,"locations":64,"responsibleParty":88,"collaborators":26,"id":91,"slug":26,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":26,"enrollmentInfo":101,"targetDuration":26,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Physicians Committee for Responsible Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Glycated hemoglobin","A1c will be measured before and after the study period","12 weeks",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"body weight","participants will track body weight weekly using a RNFO scale",{"measure":18,"description":19,"timeFrame":12},"total cholesterol","total cholesterol will be measured before and after the study period",{"measure":21,"description":22,"timeFrame":12},"LDL cholesterol","LDL cholesterol will be measured before and after the study period",{"measure":24,"description":25,"timeFrame":12},"medication usage","changes in medications to treat diabetes will be tracked during the study period",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"NA","SINGLE_GROUP","single group, multiple replications","TREATMENT",{"masking":33,"maskingDescription":26,"whoMasked":26},"NONE","This study aims to assess the feasibility and implementation of an online, plant-based, diabetes reversal program in a community setting. The study will also assess changes in glycated hemoglobin, body weight, and plasma lipids with an online 12-week, plant-based, nutrition education program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere, in addition to their value for the individual research participants.",[36],{"label":37,"type":38,"description":39,"interventionNames":40},"Vegan diet","EXPERIMENTAL","All participants will follow a low-fat vegan diet. There are no other study arms or control group.",[41],"Behavioral: plant-based diet",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"BEHAVIORAL","plant-based diet","For the duration of the study, this arm will: follow a low-fat vegan diet; weigh themselves weekly, and get fasting bloodwork before, during and after the study",[37],[49],"vegan diet",[51],{"name":52,"affiliation":5,"role":53},"Neal Barnard, MD","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":26,"email":59},"VANITA RAHMAN, MD","CONTACT","2025277500","vrahman@pcrm.org",{"name":61,"role":57,"phone":62,"phoneExt":26,"email":63},"Roxanne Becker, MBChB","2022779760","rbecker@pcrm.org",[65],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Physician Committee for Responsible Medicine","RECRUITING","Washington D.C.","District of Columbia","20016","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-77.03637,38.89511,{"lat":77,"lon":76},[80,82,83,86],{"name":56,"role":57,"phone":81,"phoneExt":26,"email":59},"202-527-7500",{"name":61,"role":57,"phone":62,"phoneExt":26,"email":63},{"name":84,"role":85,"phone":26,"phoneExt":26,"email":26},"Shannon Gray, RD","SUB_INVESTIGATOR",{"name":87,"role":85,"phone":26,"phoneExt":26,"email":26},"James Loomis, MD",{"type":53,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Vanita Rahman","Clinic Director","100483243",false,"NCT05572502","Diabetes Reversal Online Program and Study (DROP Study)","The Feasibility, Implementation and Efficacy of a Diabetes Reversal Online Program and Study (DROP Study) in an Office Setting","DROP","Inclusion Criteria:\n\n* U.S. Men and women meeting the age of majority, defined as follows: Age 19 or older in Nebraska and Alabama; Age 21 or older in Mississippi; Age 18 or older in all other states\n* Prior diagnosis of type 2 diabetes mellitus\n\nExclusion Criteria:\n\n* Use of recreational drugs in the past 6 months\n* Pregnancy or intention to become pregnant during the study period, as verified by self-report\n* Unstable medical or psychiatric illness\n* Lack of English fluency\n* Inability to maintain current medication regimen\n* Inability or unwillingness to participate in all components of the study",true,"ALL","18 Years",{"count":102,"type":103},150,"ESTIMATED","INTERVENTIONAL",[28],"This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Data will also be analyzed to see if participation in the program results in reductions glycated hemoglobin levels, body weight, and cholesterol levels.",[108],"Type 2 Diabetes",[110,111,112,113],"plant-based","vegan","diet","obesity","2024-04-16",{"date":116,"type":117},"2024-04-18","ACTUAL",{"date":119,"type":117},"2023-09-21",{"date":121,"type":103},"2027-12-31",{"name":5,"class":6},1]