[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes-juvenile-onset\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes-juvenile-onset":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":38,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100576285","phase-1-cnp-103-in-adolescent-and-adult-subjects-ages-12-35-with-recently-diagnosed-within-6-months-stage-3-type-1-diabetes-t1d-100576285",false,"NCT06783309","CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)","A Phase 1b\u002F2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 With Recent Onset Stage 3 Type 1 Diabetes","Inclusion Criteria:\n\n1. Participants who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.\n2. Men and non-pregnant, non-breast-feeding women ages 12-35 years inclusive.\n3. Documented diagnosis of Stage 3 T1D within 180 days prior to study enrollment according to American Diabetes Association (ADA) criteria.\n4. Participants must be on standard of care diabetes management including insulin therapy as a routine and also consisting of a nutrition plan, regular exercise, or other relevant specialty care as required on a patient-by-patient basis.\n5. Participants with a peak stimulated C-peptide of \\>0.2 nmol\u002FL measured from a screening mixed meal tolerance test (MMTT).\n6. Participants with an episode of diabetic ketoacidosis (DKA) must have a MMTT performed no sooner than 2 weeks after resolution of the DKA event to have a qualifying C-peptide reading.\n7. Participants on systemic corticosteroids or any medication used to treat the symptoms of T1D (other than insulin) must undergo a washout period of at least two weeks prior to enrollment and must agree to use a non-steroid alternative throughout the trial, if necessary, for any disorder requiring corticosteroids. In addition, participants must be on a stable dose of any other medications, other than insulin, for a minimum of 1 month prior to enrollment and must agree not to increase their dose from the Screening Visit through the End of Study Visit unless reviewed and approved by the medical monitor and the principal investigator.\n8. Female participants of non-childbearing potential (e.g., surgical sterilization, no menses for a year).\n9. Women of childbearing potential (WOCBP) who have agreed not to become pregnant during the study, have a negative pregnancy test at Screening Visit, and agree to use 1 highly effective form of birth control starting at initial screening and continuing throughout the entire study to Day 365.\n10. Female participants who agree to not breastfeed starting at initial Screening and throughout the entire study to Day 365.\n11. Female participants who agree to not donate ova, including autologous, starting at initial Screening and throughout the entire study to Day 365.\n12. Male participant and with a spouse or partner of childbearing potential, who themselves and their spouse or partner agree to practice an effective form of birth control as discussed with the study doctor or study staff starting at Screening and throughout the entire study to Day 365.\n13. Participants must weigh \\>35 kg at Screening for Cohort 1 (100 mg) and Cohort 2 (300 mg); participants must weigh \\>50 kg at Screening for Cohort 3 (600 mg).\n14. Body mass index (BMI):\n\n    1. Participants 12-17 years: BMI Z-Score within 5th and 95th percentile based on participant's age (e.g., Baylor College of Medicine Age-based Pediatric Growth Reference Charts: BMI Z-Score and Percentile Calculator)\n    2. Participants 18-35 years: 18.0-30.0 (not inclusive)\n\nExclusion Criteria:\n\n1. Participants unable to comply with prohibited medication outlined in the protocol.\n2. Exclusion of additional immunomodulation will be at the discretion of the Medical Monitor and study site Investigator.\n3. Participants with a history of tuberculosis or positive Quantiferon test.\n4. Participants who received vaccinations in the following time frame:\n\n   1. Any live vaccine within 28 days prior to Screening.\n   2. Any subunit vaccine within 14 days prior to Screening.\n   3. Any COVID-19 vaccine series within 14 days prior to Screening.\n   4. Any other planned vaccine starting 14 days prior to Screening and through study Day 90 and 1 week after. (Note: The annual influenza vaccine is not an exclusion criterion.)\n5. Known or suspected acute infection, including COVID-19 at the time of Screening or within 2 weeks prior to Screening. After confirmed recent COVID-19 infection, a minimum of 2 weeks of recovery post-acute infection is required.\n6. Participants with Screening laboratory test results that are outside the normal limits and considered by the Investigator to be clinically significant.\n7. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen\u002Fantibody as determined at Screening.\n8. Participants with a history of or currently active immune disorders other than T1D (including autoimmune disease) unless the condition, after discussion with the Medical Monitor, has been deemed to be acceptable for the participant's participation in this study.\n9. Participants with a clinical history of significant cardiovascular disease in the past 12 months.\n10. Participants with a complication or medical history of malignant tumor, other than basal cell or squamous cell carcinomas of the skin.\n11. Participants who, in the Investigator's opinion, will be unable to adhere to study visits and procedures.\n12. Participants who have received investigational therapy other than CNP-103 within 28 days or 5 half-lives, whichever is longer, prior to Screening.\n13. Participants with any known active condition which, in the Investigator's opinion, makes the participant unsuitable for study participation.\n14. Known sensitivity to any components of CNP-103.","ALL","12 Years","35 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a Phase 1b\u002F2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).",[28,29,30,31,32,33,34,35,36,37],"Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes in Adolescence","Type 1 Diabetes in Children","Type 1 Diabetes (Juvenile Onset)","Type 1 Diabetes","Type 1 Diabetes Patients","Type 1 Diabetes Mellitis",[39,29,40,41,42,30,43,44],"Diabetes","Stage 3","Adolescents","Adults","Newly Diagnosed","Recently Diagnosed","RECRUITING","2026-06-30",{"date":48,"type":49},"2026-07-02","ACTUAL",{"date":51,"type":49},"2025-05-12",{"date":53,"type":21},"2027-06",{"name":55,"class":56},"COUR Pharmaceutical Development Company, Inc.","INDUSTRY",33,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100634798","mediterranean-diet-and-oxidative-stress-in-type-1-diabetes-medox-t1d-100634798","NCT07544368","Mediterranean Diet and Oxidative Stress in Type 1 Diabetes (MEDOX-T1D)","The Relationship Between Adherence to the Mediterranean Diet and Oxidative Stress in Children With Type 1 Diabetes","MEDOX-T1D","Inclusion Criteria:\n\n* Ages 10-18 years\n* BMI between the 5th and 95th percentile (normal to overweight)\n* Diagnosis of Type 1 Diabetes for ≥1.5 years\n* Users of a continuous glucose monitoring (CGM) system\n* No other comorbidities and not taking medications\n* Non-smokers and non-alcohol users (including e-cigarettes)\n* Written informed consent provided by the participant and their parent\u002Fguardian\n\nExclusion Criteria:\n\n* Presence of any acute or chronic disease other than Type 1 Diabetes\n* Current use of any medications\n* BMI ≥ 95th percentile (obese)\n* Presence of an eating disorder\n* Use of tobacco, e-cigarettes, or alcohol","FEMALE","10 Years","18 Years",{"count":70,"type":21},54,[72],"NA","Achieving optimal glycemic control in type 1 diabetes requires a holistic approach that includes individualized medical nutrition therapy in addition to appropriate insulin therapy. When diabetes is poorly managed, metabolic control is impaired. Hyperglycemic events increase oxidative stress in the body and can lead to complications. The aim of this study is to examine the effect of a 12-week Mediterranean diet on oxidative stress markers in children with type 1 diabetes who do not meet the metabolic target (HbA1c \\> 7%) and whose adherence to the Mediterranean diet is \"poor\" and \"needs improvement\".\n\nThe study, planned between March 2026 and March 2027, will be conducted with girls aged 10-18 years with type 1 diabetes who are followed up at the Department of Pediatric Endocrinology, Istanbul Faculty of Medicine, Istanbul University. In the first phase, participants were divided into groups based on their HbA1c levels: those with HbA1c ≤ 7 met the metabolic target (Group A); Those with HbA1c \\> 7 will be divided into two groups: those not meeting the metabolic target (Group B). In the second stage, the intervention group will be determined according to the results of the KIDMED, the pediatric Mediterranean diet adherence scale. Those in Group B who did not meet the metabolic targets and those with \"poor\" and \"need improvement\" KIDMED results will form the intervention group (Group C). Adolescents in Group C will receive a 12-week Mediterranean diet intervention. Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing the 'Personal Information Form', 'Biochemical Parameters Form', '3-Day Nutrition Questionnaire', 'KIDMED scale', and 'Sensor Data Form'. The obtained data will be analyzed both individually and before-and-after using SPSS 26.\n\nThe findings are expected to show improvement in OS markers in the intervention group. Improvement in glycemic control markers is also predicted. A decrease in HbA1c levels, a reduction in blood sugar fluctuations, and an increase in the duration of staying within the target range are expected.\n\nThis study is expected to contribute to the literature by revealing the effects of the Mediterranean diet on oxidative stress and metabolic control parameters in type 1 diabetes. It is anticipated that the findings will support the potential role of dietary approaches with antioxidant properties not only in glycemic control but also in oxidative stress levels and long-term complication risks.",[34,75,76],"Continuous Glucose Monitoring System","Oxidative Stress",[35,78,76],"Mediterranean Diet","NOT_YET_RECRUITING","2026-04-24",{"date":82,"type":49},"2026-04-29",{"date":84,"type":21},"2026-04",{"date":86,"type":21},"2027-03",{"name":88,"class":89},"Istanbul University","OTHER"]