[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478107":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":60,"id":66,"slug":10,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":10,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":10,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":10,"overallStatus":44,"whyStopped":10,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"City of Hope Medical Center","OTHER",[8,13,16,19,22,25],{"label":9,"type":10,"description":9,"interventionNames":11},"Adults with type 1 diabetes",null,[12],"Other: One-time blood (up to 100 ml) will be drawn and the amount of blood drawn is based on weight. Saliva and urine will be collected during the blood draw visit.",{"label":14,"type":10,"description":14,"interventionNames":15},"Adult healthy volunteers",[12],{"label":17,"type":10,"description":17,"interventionNames":18},"Children with type 1 diabetes",[12],{"label":20,"type":10,"description":20,"interventionNames":21},"Adults with type 2 diabetes",[12],{"label":23,"type":10,"description":23,"interventionNames":24},"Adults with high blood sugar",[12],{"label":26,"type":10,"description":26,"interventionNames":27},"Those at risk of developing type 1 diabetes",[12],[29],{"type":6,"name":30,"description":30,"armGroupLabels":31,"otherNames":10},"One-time blood (up to 100 ml) will be drawn and the amount of blood drawn is based on weight. Saliva and urine will be collected during the blood draw visit.",[14,23,9,20,17,26],[33],{"name":34,"affiliation":5,"role":35},"Rupangi Vasavada, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Study Coordinator","CONTACT","1-866-444-7538","Islets@coh.org",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Duarte","California","91010","United States",{"type":50,"coordinates":51},"Point",[52,53],-117.97729,34.13945,{"lat":53,"lon":52},[56],{"name":38,"role":39,"phone":57,"phoneExt":10,"email":41},"866-444-7538",{"type":59,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[61,63],{"name":62,"class":6},"Icahn School of Medicine at Mount Sinai",{"name":64,"class":65},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100478107",false,"NCT05505669","Circulating Biomarkers in the Development of Type 1 Diabetes","Circulating Biomarkers of Beta Cell Loss\u002FDysfunction in Diabetes","Inclusion Criteria:\n\n* Documented informed consent\u002F assent from the subject\n* ONE of the following:\n\n  * Type 1 diabetes patients (including pediatric patients) -OR-\n  * Adult type 2 diabetes patients -OR-\n  * Volunteers who are islet auto-antibody positive (i.e. insulin, GAA, IA-2, IAA and ZnT8 antibodies) with HbA1c ≤ 5.6% (including pediatric patients)-OR-\n  * Adult participants with clinical diagnosis of high blood sugar (i.e. HbA1c of 5.7% to 6.4%)-OR-\n  * Adult control subjects with HbA1cc ≤ 5.6%\n* Weight ≥ 30 kg\n* Willingness to: Provide blood sample(s) and if applicable: permit medical record\u002F clinical laboratory result review\n\nExclusion Criteria:\n\n* Control subjects must not have any chronic conditions or have undergone cellular, tissue or organ transplant\n* Sickle cell disease or anemia (exception: anemia that is corrected with treatment and source documents confirm corrected blood parameters current within 6 months of blood draw)\n* Active infection\n* Active malignancy (i.e., currently undergoing treatment)\n* Immunomodulatory therapy within 1 year of planned blood draw (may include immune checkpoint inhibitors, thalidomide, lenalidomide, pomalidomide, imiquimod, Bacillus Calmette-Guérin, and cytokines\u002F growth factors (e.g. interferons, interleukins)\n* Type 1 diabetes only: polyclonal regulatory T cell and\u002For dendritic cell therapy\n* Bleeding disorder\n* Women of childbearing potential: Pregnant\u002F nursing (Note: Eligibility may be deferred per blood donation timelines for pregnancy\u002Fnursing)\n* Diabetic patients only: Any clinical condition that might be adversely affected by the removal of up to 100 mL of blood\n* An employee who is under the direct\u002F indirect supervision of the PI\u002F a co-investigator\u002F the study manager\n* A direct study team member",true,"ALL",{"count":75,"type":76},165,"ESTIMATED","OBSERVATIONAL","More than 100 million U.S. adults are now living with diabetes or prediabetes. Investigators still do not fully understand how diabetes develops and how the disease worsens. Insulin is a hormone that helps the body use sugar as a fuel and control blood-sugar levels. People with diabetes have problems making insulin. This is because their insulin-producing beta cells -in the pancreas-are damaged or destroyed. A biomarker is a biological molecule (such as DNA, RNA (the genetic material of cells) or protein) that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker can be measured and found in blood and\u002For other body fluids (such as saliva and urine). Understanding the biology of beta cells could help find diabetes-related biomarkers. The discoveries from this research could help with early diagnosis of diabetes and lead to the creation of therapies for treating diabetes.",[80],"Diabetes","2026-06-22",{"date":83,"type":84},"2026-06-24","ACTUAL",{"date":86,"type":84},"2022-03-29",{"date":88,"type":76},"2029-06-21",{"name":5,"class":6},1]