[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554801":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketogenic Diet","EXPERIMENTAL","The Ketogenic Diet group will consume a very-low carbohydrate diet (\\\u003C50 g\u002Fday) diet. Participants will receive isocaloric packed-out meals for 12 weeks.",[13],"Behavioral: Ketogenic Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","ACTIVE_COMPARATOR","The Standard Care group will consume a diet consistent with the guidelines recommended by the American Diabetes Association that is high in non-starchy vegetables and lean protein sources and low in added sugar. Participants will receive isocaloric packed-out meals for 12 weeks.",[19],"Behavioral: Standard Diet",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Participants will consume a very-low-carbohydrate ketogenic diet for 12 weeks.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard Diet","Participants will consume an American Diabetes Association-recommended standard diet for 12 weeks.",[15],[31],{"name":32,"affiliation":5,"role":33},"Samuel Klein, MD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Tara Wilmot, RDN","CONTACT","314-399-8576","tara.wilmot@wustl.edu",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Max C Petersen, MD PhD","314-362-8450","max.p@wustl.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","St Louis","Missouri","63110","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-90.19789,38.62727,{"lat":56,"lon":55},[59,60,61],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},{"name":32,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100554801","efficacy-and-safety-of-a-ketogenic-diet-in-type-1-diabetes-100554801",false,"NCT06503809","Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes","Inclusion Criteria:\n\n* Age ≥18 and ≤65 years\n* T1D diagnosed \\>1 year prior to screening\n* HbA1c 7.0%-9.0%\n* Stable insulin delivery method for the past 30 days\n* Ability to read all device instructions and insulin pump settings\n* eGFR ≥60 mL\u002Fmin\u002F1.73 m2\n* Use of an insulin pump or insulin delivery by multiple daily injections\n* Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products\n* Use of cellular phone with data capability for wireless connectivity to the CGM system.\n\nExclusion Criteria:\n\n* Body mass index \\\u003C20.0 or \\>34.9 kg\u002Fm2\n* Severe gastroparesis or history of bariatric surgery\n* Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening\n* Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg)\n* Taking diabetes medications, other than insulin (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA)\n* Structured exercise \\>210 minutes per week\n* Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period\n* Unstable weight (\\>4% change in the last 2 months)\n* Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease)\n* Anemia (Hgb \\\u003C10 g\u002FdL)\n* Major psychiatric illness\n* Active tobacco use (\\>8 cigarettes\u002Fday) or illegal drug use\n* Regular alcohol consumption (\\>10 standard drinks per week)\n* Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study\n* Familial hypercholesterolemia\n* Active eating disorder\n* Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion\u002Fsensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy\n* Already consuming a low-carbohydrate (\\\u003C130 g\u002Fday) diet\n* Persons who are not able to grant voluntary informed consent\n* Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.","ALL","18 Years","65 Years",{"count":74,"type":75},58,"ESTIMATED","INTERVENTIONAL",[78],"NA","Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.",[81],"Diabetes Mellitus, Type 1",[83,84,85,86,87],"Type 1 diabetes","Ketogenic diet","Insulin sensitivity","Continuous glucose monitoring","Hypoglycemia","2026-03-17",{"date":90,"type":91},"2026-03-19","ACTUAL",{"date":93,"type":91},"2024-08-12",{"date":95,"type":75},"2030-03-31",{"name":5,"class":6},1]