[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403681":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":46,"locations":55,"responsibleParty":73,"collaborators":32,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":32,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":32,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":58,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Control: 12 hour eating period","EXPERIMENTAL","Control: Habitual daily eating period (no meal time restrictions)",[13,14,15],"Behavioral: Components Common to All Study Arms.","Behavioral: Control","Device: Continuous Glucose Monitor",{"label":17,"type":10,"description":18,"interventionNames":19},"Time Limited Eating","Time Limited Eating: 8-hour eating period (16 hours of daily fasting).",[20,13,15],"Behavioral: Time Limited Eating",[22,28,33,37],{"type":23,"name":17,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","The TLE intervention arm will involve instructing participants to consume their usual kind and amount of food and beverages (all calories) within a pre-specified 8-hour period, fasting for the remaining 16-hours. They will be free to divide their food and beverage intake into as many meals or snacks as desired during the 8-hour period. Participants will be allowed to consume non-caloric beverages (water, tea, coffee) during the fasting period. No energy restriction will be required.",[17],[27],"TLE",{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Components Common to All Study Arms.","All participants will receive two hours of standard nutrition counseling recommended for adolescents living with T2D. No specific caloric restriction will be recommended. All participants will maintain their usual lifestyle, including physical activity and sleep patterns. Physical activity and sleep recommendations consistent with the American Academy of Pediatrics guidelines for adolescents will be encouraged but not formally prescribed.",[9,17],null,{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Control","Participants assigned to the control arm will be instructed to consume food over a 12-h or more eating window. No energy restriction will be required.",[9],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":32},"DEVICE","Continuous Glucose Monitor","All participants will be trained to wear a blinded continuous glucose monitor sensor using manufacturer educational materials under the supervision of research staff. Participants will be asked to wear the CGM for the duration of the study. During each study visit, the CGM reader will be connected to the site database to create an individual participant report. Participants will be provided enough sensors to replace the sensor every 14 days. The participants and guardians will be educated on how to use the CGM and receive 1:1 coaching on how to change the sensor, which will be completed either independently or under study team guidance. At each weekly phone meeting, study staff will monitor any challenges related to CGM wear, including participant discomfort, skin adherence, and other issues.",[9,17],[43],{"name":44,"affiliation":5,"role":45},"Alaina Vidmar, MD","PRINCIPAL_INVESTIGATOR",[47,51],{"name":44,"role":48,"phone":49,"phoneExt":32,"email":50},"CONTACT","323-361-3385","avidmar@chla.usc.edu",{"name":52,"role":48,"phone":53,"phoneExt":32,"email":54},"Gisell Figueroa","323-361-4664","gfigueroa@chla.usc.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Children's Hospital of Los Angeles","RECRUITING","Los Angeles","California","90027","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-118.24368,34.05223,{"lat":68,"lon":67},[71],{"name":72,"role":48,"phone":49,"phoneExt":32,"email":50},"Alaina P Vidmar, MD",{"type":45,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Alaina P. Vidmar, MD","Assistant Professor of Pediatric, Pediatric Endocrinologist","100403681","time-limited-eating-in-adolescents-with-type-2-diabetes-kt2d-100403681",false,"NCT04536480","Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)","All adolescents with T2D and referred to the endocrinology clinic at CHLA will be screened. Inclusion criteria are: (1) age 12-21 years; (2) Tanner stage III and above; (3) diagnosis of T2D based on the ADA diagnostic guidelines; (4) hemoglobin A1c \\\u003C 9%; and (5) participant must be willing and able to adhere to the assessments, visit schedules, and eating\u002Ffasting periods. To limit confounding factors, individuals will be considered ineligible to participate if they meet any of the following exclusion criteria: (1) previous diagnosis of Prader-Willi Syndrome, brain tumor or hypothalamic obesity; (2) serious developmental or intellectual disability; (3) previous diagnosis or subthreshold symptoms of an eating disorder (anorexia nervosa, bulimia nervosa, binge-eating disorder); (4) parent\u002Fguardian-reported physical, mental of other inability to participate in the assessments (e.g., inability to wear CGM, inability to undergo imaging testing without sedation); (5) previous or planned bariatric surgery; (6) current planned use of an anti-obesity or other diabetes medication (e.g., phentermine, topiramate, orlistat, glucagon-like-peptide-1 agonist, naltrexone, or bupropion); or (7) current participation in other interventional weight loss studies.","ALL","12 Years","21 Years",{"count":86,"type":87},100,"ESTIMATED","INTERVENTIONAL",[90],"NA","To find the effectiveness of a diet plan (Time Limited Eating or TLE) on glycemic control, B-cell function, body fat, and body mass index (BMI) in adolescents with type 2 diabetes.",[93,94,95],"Pediatric Obesity","Type 2 Diabetes","Time Restricted Eating",[97,94,17],"Intermitted-fasting","2025-06-18",{"date":100,"type":101},"2025-06-24","ACTUAL",{"date":103,"type":101},"2023-04-15",{"date":105,"type":87},"2027-12-01",{"name":5,"class":6},1]