[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06507722":3,"trial-entities:NCT06507722":140,"trial-summary:NCT06507722":145},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":44,"secondary_outcomes":56,"sex":99,"minimum_age":100,"maximum_age":101,"healthy_volunteers":102,"eligibility_criteria":103,"std_ages":115,"locations":117,"central_contacts":133,"overall_officials":135,"references":138,"see_also_links":139},"NCT06507722","IRB00428863","Night Owl Metabolism","Night Owl Metabolism: Investigating the Impact of Chronotype on Glucose Metabolism in Youth","RECRUITING","2030-01-31","2026-05","2026-05-11","2025-02-25","Johns Hopkins University","OTHER",null,"The proposed study uses a novel and rigorous randomized cross-over study design in youth (18-23y) with late and non-late chronotype (n=35 per group) to assess the glycemic effect of \"aligning\" an oral glucose tolerance test (OGTT) or first-meal of day to a subject's chronotype. Both groups will undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity within-subject (primary outcome) and between groups (Aim 1). Then, youth will also undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring to compare post-prandial glucose excursions within-subject and between groups (Aim 2). A pilot Exploratory Aim 3 (n=12 per group) will investigate delayed melatonin patterns under dim-light as a potential pathophysiologic mechanism behind abnormal glucose tolerance in youth with late chronotype on morning OGTTs.",[18,19,20],"PreDiabetes","Overweight","Impaired Glucose Tolerance",[22,23],"chronotype","sleep","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},70,"ESTIMATED",[32,39],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DIAGNOSTIC_TEST","Timing of OGTT","In Aim 1, timing of oral glucose tolerance test will be altered.",[37,38],"Cohort A - Late Chronotype first, then alternate","Cohort B - Non-late Chronotype first, then alternate",{"type":40,"name":41,"description":42,"armGroupLabels":43},"BEHAVIORAL","Timing of Standardized Meal","In Aim 2, timing of a standardized meal will be altered.",[37,38],[45,49,52],{"measure":46,"description":47,"timeFrame":48},"2-Hour Difference in Glucose","Within-subject difference in 2-hour glucose after glucose ingestion on OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.","Day 4 and Day 11 of Aim 1 derived from OGTT",{"measure":50,"description":51,"timeFrame":48},"Insulin Sensitivity (by Oral Minimal Model)","Within-subject difference in insulin sensitivity (derived from oral Minimal Model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.",{"measure":53,"description":54,"timeFrame":55},"2-hour Incremental Area Under the Curve (iAUC) for glucose","Within-subject difference in iAUC for glucose from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal.","Day 1 and Day 8 of Aim 2 during post-prandial period following each standardized meal",[57,61,64,67,71,74,77,81,84,87,90,93,96],{"measure":58,"description":59,"timeFrame":60},"Difference in Fasting Glucose","Within-subject difference in fasting glucose at start of OGTT between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.","Day 4 and Day 11 of Aim 1 obtained before OGTT",{"measure":62,"description":63,"timeFrame":48},"Insulin secretion indices","Within-subject difference in insulin secretion (dynamic phase, static phase, total and insulin secretory rate) from c-peptide minimal model between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.",{"measure":65,"description":66,"timeFrame":48},"Incremental Area Under the Curve (iAUC) for Insulin","Within-subject difference in iAUC for insulin after glucose ingestion between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.",{"measure":68,"description":69,"timeFrame":70},"Hemoglobin A1c levels","Analysis of between group differences in hemoglobin A1c levels","Day 4 of Aim 1 during first OGTT Visit",{"measure":72,"description":73,"timeFrame":48},"Difference in Disposition Index","Within-subject difference in disposition index (derived from insulin sensitivity and insulin secretion metrics) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.",{"measure":75,"description":76,"timeFrame":48},"Difference in Insulin Clearance","Within-subject difference in insulin clearance (derived from Watanabe et al. model) between early and late OGTT (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late OGTT.",{"measure":78,"description":79,"timeFrame":80},"Mean Glucose","Analysis of between group differences in mean glucose derived from continuous glucose monitor","Up to 8 days",{"measure":82,"description":83,"timeFrame":80},"Percent Time Spent Above 120 mg\u002FdL","Analysis of between group differences in time spent above 120 mg\u002FdL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days)\\]",{"measure":85,"description":86,"timeFrame":80},"Percent Time Spent Above 140 mg\u002FdL","Analysis of between group differences in time spent above 140 mg\u002FdL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).",{"measure":88,"description":89,"timeFrame":80},"Number of Excursions greater than 140mg\u002FdL","Analysis of between group differences in the number of excursions above 140 mg\u002FdL derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).",{"measure":91,"description":92,"timeFrame":55},"Difference in Post-prandial peak","Within-subject difference in post-prandial peak from continuous glucose monitor between early and late Meal (primary analysis) in the late chronotype group and secondary analysis will be between group differences between early and late Meal",{"measure":94,"description":95,"timeFrame":80},"Standard Deviation of Glucose","Analysis of between group differences in standard deviation of glucose derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).",{"measure":97,"description":98,"timeFrame":80},"Coefficient of Variation of Glucose","Analysis of between group differences in coefficient of variation of glucose derived from continuous glucose monitor. Over course of wearing continuous glucose monitor for Aim 2 (8 days).","ALL","18 Years","23 Years",true,{"inclusion":104,"exclusion":109,"raw_text":114},[105,106,107,108],"Overweight similar to (BMI ≥ 85th percentile but \\\u003C95th percentile for age and sex per Centers for Disease Control and Prevention growth curves (as Centers for Disease Control and Prevention growth curves contain ages ≤ 20y; if ages 21-23 years, the BMI ≥ 85th and \\\u003C95th percentile equivalents for a 20-year-old will be used))","Post-pubertal","Normal sleep duration (avg. \\>7 hours of sleep per night)","Social jetlag (difference between weekend and weekday sleep) of \\\u003C 2 hours.",[110,111,112,113],"Known diabetes, sleep disorders, major organ system illness, pregnancy, or genetic syndrome","Medication use known to affect insulin sensitivity, glucose tolerance, or circadian rhythm","Screening high risk for obstructive sleep apnea","Night shift work.","Inclusion Criteria:\n\n* Overweight similar to (BMI ≥ 85th percentile but \\\u003C95th percentile for age and sex per Centers for Disease Control and Prevention growth curves (as Centers for Disease Control and Prevention growth curves contain ages ≤ 20y; if ages 21-23 years, the BMI ≥ 85th and \\\u003C95th percentile equivalents for a 20-year-old will be used))\n* Post-pubertal\n* Normal sleep duration (avg. \\>7 hours of sleep per night)\n* Social jetlag (difference between weekend and weekday sleep) of \\\u003C 2 hours.\n\nExclusion Criteria:\n\n* Known diabetes, sleep disorders, major organ system illness, pregnancy, or genetic syndrome\n* Medication use known to affect insulin sensitivity, glucose tolerance, or circadian rhythm\n* Screening high risk for obstructive sleep apnea\n* Night shift work.",[116],"ADULT",[118],{"facility":119,"status":8,"city":120,"state":121,"zip":122,"country":123,"contacts":124,"geoPoint":130},"Johns Hopkins School of Medicine","Baltimore","Maryland","21287","United States",[125],{"name":126,"role":127,"phone":128,"email":129},"Talia Hitt, MD\u002FMPH\u002FMSHP","CONTACT","860-324-0072","thitt2@jhmi.edu",{"lat":131,"lon":132},39.29038,-76.61219,[134],{"name":126,"role":127,"phone":128,"email":129},[136],{"name":126,"affiliation":13,"role":137},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":141,"biomarkers":144},[142,19,143],"Glucose Intolerance","Prediabetes",[],{"nct_id":4,"found":102,"summary":146,"prompt_version":156},{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is a randomized cross-over study involving about 70 participants, divided into two groups based on their chronotype (late or non-late). Each participant will experience both aligned and misaligned timings for tests and meals.","completed","Night Owl Metabolism Study for Prediabetes and Overweight Youth","This study, called \"Night Owl Metabolism,\" is looking at how the timing of meals and glucose tests affects blood sugar in young people (ages 18-23) who are overweight or have prediabetes. Researchers want to see if aligning these timings with a person's natural sleep-wake cycle (chronotype) can improve how their body handles sugar. You would undergo two types of tests: an oral glucose tolerance test (OGTT), which measures how your body processes sugar, and standardized meals. The study aims to see if changing the timing of these interventions improves blood sugar levels and insulin sensitivity (how well your body uses insulin to control blood sugar). The study is currently recruiting about 70 participants.","Blood sugar and insulin sensitivity will be measured on Day 4 and Day 11 for the oral glucose tolerance tests, and during the post-meal period on Day 1 and Day 8 for the standardized meals.",113,"You would undergo two oral glucose tolerance tests and two standardized meals. Continuous glucose monitoring will be used during the standardized meals.","Not stated in the trial record.",[],"v2"]