[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607207":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":53,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":20,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Very Low-Energy Ketogenic Therapy with Advanced Hybrid Closed Loop in Adults with T1D and Obesity","EXPERIMENTAL","Participants will undergo a 4-week Very Low-Energy Ketogenic Therapy (600-800 kcal\u002Fday) using commercial meal replacements with very low carbohydrate content, high biological value proteins (milk, whey, pea, soy), and added fiber (inulin, FOS). Gluten-free, lactose-free, and vegan options will be available. Therapy will be performed while continuing intensive insulin treatment with an Advanced Hybrid Closed Loop (AHCL) system. Participants will perform daily self-monitoring of capillary ketonemia, maintain hydration, and abstain from intense exercise. Follow-up visits at weeks 1, 2, 3, and 4 will assess safety, metabolic control, and weight loss. After completion, a structured reintroduction of conventional meals will be initiated.",[13],"Dietary Supplement: VLEKT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","VLEKT","Participants will follow a Very Low-Energy Ketogenic Therapy (VLEKT) providing 600-800 kcal\u002Fday for 4 weeks. The intervention consists of meal replacements (solid or liquid, ready-to-use or reconstituted) with very low carbohydrate content, high-quality proteins (milk, whey, pea, soy), and fiber (inulin, FOS). Gluten-free, lactose-free, and vegan options are available. Meal replacements are provided by Therascience or Penta at discounted prices. Participants will self-monitor capillary ketonemia daily, maintain adequate hydration, and avoid intense physical exercise. The Advanced Hybrid Closed Loop (AHCL) insulin delivery system will be used throughout the study with periodic adjustments based on device downloads. At the end of the 4-week intervention, a structured reintroduction of conventional meals will be initiated.",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":26,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"University Hospital Policlinico Consorziale","RECRUITING","Bari","Italy","70124","IT",{"type":30,"coordinates":31},"Point",[32,33],16.86982,41.12066,{"lat":33,"lon":32},[36,41,44,47,49,51],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Lucia Coriolano","CONTACT","+393426275748","luciacoriolano@outlook.com",{"name":42,"role":43,"phone":20,"phoneExt":20,"email":20},"Francesco Giorgino, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":45,"role":46,"phone":20,"phoneExt":20,"email":20},"Angelo Cignarelli, M.D., Ph.D.","SUB_INVESTIGATOR",{"name":48,"role":46,"phone":20,"phoneExt":20,"email":20},"Sergio Di Molfetta, M.D., Ph.D.",{"name":50,"role":46,"phone":20,"phoneExt":20,"email":20},"Carmine Piccolo, M.D.",{"name":52,"role":46,"phone":20,"phoneExt":20,"email":20},"Sara de Candia, RD",{"type":43,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Francesco Giorgino","Professor of Endocrinology, Director of Department of Precision and Regenerative Medicine and Ionian Area, Chief of Division of Endocrinology - University Hospital Policlinico Consorziale","100607207","vey-low-energy-ketogenic-therapy-in-adults-with-type-1-diabetes-and-obesity-on-intensive-insulin-therapy-using-advanded-hybrid-closed-loop-system-100607207",false,"NCT07185555","Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System","Applying Very Low Calorie Ketogenic Diet to the Treatment of Obesity in People With Type 1 Diabetes on Intensive Insulin Therapy Using Automated Insulin Delivery System","KET1D","Inclusion Criteria:\n\nAge ≥ 18 years\n\nDiagnosis of type 1 diabetes or autoimmune diabetes for ≥ 12 months\n\nBMI ≥ 30 kg\u002Fm²\n\nHbA1c \\\u003C 9%\n\nKnowledge and use of carbohydrate counting\n\nUse of an Advanced Hybrid Closed Loop (AHCL) system for ≥ 3 months and willingness to maintain it during the study\n\nAt least 1 diabetology follow-up visit in the last 12 months (including telemedicine)\n\nWillingness to purchase meal replacements for the entire study duration\n\nExclusion Criteria:\n\nKetoacidosis, severe hypoglycemia with seizures\u002Fcoma, or severe hyperglycemia requiring hospitalization in the last 6 months\n\nFebrile illness within the last 2 weeks\n\nDietary restrictions or intolerances incompatible with study food supplies\n\nCeliac disease, gastroparesis, food allergies\n\nIntense physical exercise \\>2 hours on \\>3 days per week\n\nHistory or risk of eating disorder, or other psychiatric disorders\n\nRecreational drug use or excessive alcohol consumption\n\nChronic kidney disease (eGFR \\\u003C60 ml\u002Fmin)\n\nGallstones\n\nLiver failure\n\nHeart failure (NYHA III-IV), unstable angina, cardiac arrhythmia, myocardial infarction, or stroke within the last 12 months\n\nRespiratory failure\n\nSevere or active infections\n\nPlanned elective surgery\n\nRare metabolic diseases (porphyria, CPT2 deficiency, mitochondrial fatty acid oxidation defect, pyruvate carboxylase defect)\n\nPregnancy (current or actively trying to conceive)\n\nBreastfeeding\n\nCurrent glucocorticoid therapy (except stable low-dose, inhaled, or replacement for adrenal insufficiency)\n\nOther serious medical conditions that might interfere with participation or study completion in the investigator's judgment\n\nParticipant judged unable or unwilling to complete the study","ALL","18 Years","99 Years",{"count":68,"type":69},14,"ESTIMATED","INTERVENTIONAL",[72],"NA","Overweight and obesity are frequent in adults with type 1 diabetes (T1D), with prevalence exceeding 50% in recent studies. Excess weight in T1D is associated with higher cardiometabolic risk and therapeutic challenges, while effective and safe weight management strategies are still limited.\n\nThis single-center, single-arm feasibility study will evaluate the efficacy and safety of a Very Low-Energy Ketogenic Therapy (VLEKT; 600-800 kcal\u002Fday) in adults with T1D and obesity treated with Advanced Hybrid Closed Loop (AHCL) insulin delivery systems. Participants will follow a structured 4-week program with commercial very-low-carbohydrate, high-protein meal replacements, under close medical supervision.\n\nThe primary endpoint is change in body weight at 4 weeks. Secondary outcomes include body composition, muscle strength, glucose metrics, insulin requirements, biochemical parameters, and patient-reported outcomes. Safety will be assessed through hypoglycemia incidence, ketone monitoring, and occurrence of diabetic ketoacidosis (DKA).\n\nThe study will enroll 14 participants. It is expected that VLEKT will achieve \\~5% weight loss within one month while maintaining glycemic safety under AHCL technology.",[75,76],"Type 1 Diabetes (T1D)","Obesity (Disorder)",[78,79,80,81,82,83,84],"Type 1 Diabetes Mellitus","Obesity","Very Low-Energy Ketogenic Diet","Insulin Therapy","Weight Loss","Continuous Glucose Monitoring","Advanced Hybrid Closed Loop","2025-09-24",{"date":87,"type":88},"2025-09-29","ACTUAL",{"date":90,"type":88},"2025-01-16",{"date":92,"type":69},"2026-03-01",{"name":5,"class":6},1]