[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06007404":3,"trial-entities:NCT06007404":95,"trial-summary:NCT06007404":101},{"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":23,"study_type":24,"primary_purpose":15,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":30,"secondary_outcomes":48,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":71,"locations":74,"central_contacts":83,"overall_officials":89,"references":93,"see_also_links":94},"NCT06007404","HUM00208301","Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents","The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance","RECRUITING","2027-09","2026-07","2026-07-13","2023-09-06","University of Michigan","OTHER",null,"This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.",[18,19,20,21,22],"Type 2 Diabetes","Insulin Resistance","Obesity","Metabolic Disease","PreDiabetes",[],"OBSERVATIONAL",[],{"count":27,"type":28},175,"ESTIMATED",[],[31,35,38,42,45],{"measure":32,"description":33,"timeFrame":34},"Glucose (OGTT)","Plasma Glucose (mg\u002FdL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose","120 minutes",{"measure":36,"description":37,"timeFrame":34},"Insulin (OGTT)","Plasma Insulin (µU\u002FmL) will be measured prior to, and throughout, an Oral Glucose Tolerance Test (OGTT). Measurements will be taken at baseline (fasting) and 30, 60, 90 and 120 minutes after consumption of glucose dose",{"measure":39,"description":40,"timeFrame":41},"Glucose (MMTT)","Plasma Glucose (mg\u002FdL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.","180 minutes",{"measure":43,"description":44,"timeFrame":41},"Insulin (MMTT)","Plasma Insulin (µU\u002FmL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake.",{"measure":46,"description":47,"timeFrame":41},"Monocyte \u002Fmacrophage populations by flow cytometry","Frequencies by flow cytometry. Measurements will be taken at baseline sample and 180 minutes after consumption of high fat shake",[49,52],{"measure":50,"description":51,"timeFrame":41},"Free fatty acids (MMTT)","Serum Free fatty acids (mmol\u002FL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake",{"measure":53,"description":54,"timeFrame":41},"Triglycerides (MMTT)","Serum Triglycerides (mg\u002FdL) will be measured prior to, and throughout, a Mixed Meal Tolerance Test (MMTT). Measurements will be taken at baseline (fasting) and 30, 60, 90, 120 and 180 minutes after consumption of high fat shake","ALL","14 Years","18 Years",true,{"inclusion":60,"exclusion":65,"raw_text":70},[61,62,63,64],"Between 14 and 18 years of age","Tanner stage 4 or 5 (mature adult stage of puberty)","Normal weight (BMI ≥ 5th percentile \\& \\\u003C 85th percentile), overweight (BMI \\> 86th percentile) \\& \\\u003C 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and\u002For pre-diabetes (HbA1c \\> 5.7%)","For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes",[66,67,68,69],"Currently pregnant","Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management","Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff","Allergies or intolerance to milk, soy, or palm oil","Inclusion Criteria:\n\n* Between 14 and 18 years of age\n* Tanner stage 4 or 5 (mature adult stage of puberty)\n* Normal weight (BMI ≥ 5th percentile \\& \\\u003C 85th percentile), overweight (BMI \\> 86th percentile) \\& \\\u003C 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and\u002For pre-diabetes (HbA1c \\> 5.7%)\n* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes\n\nExclusion Criteria:\n\n* Currently pregnant\n* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management\n* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff\n* Allergies or intolerance to milk, soy, or palm oil",[72,73],"CHILD","ADULT",[75],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Ann Arbor","Michigan","48109","United States",{"lat":81,"lon":82},42.27756,-83.74088,[84],{"name":85,"role":86,"phone":87,"email":88},"The Singer Lab Team","CONTACT","(734) 615-4938","MiMoStudy@med.umich.edu",[90],{"name":91,"affiliation":13,"role":92},"Kanakadurga Singer, MA, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":99},[20,97,98],"Prediabetes","Type 2 Diabetes Mellitus",[100],"Hemoglobin A1C Measurement",{"nct_id":4,"found":58,"summary":102,"prompt_version":111},{"design":103,"status":104,"heading":6,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is an observational study planning to enroll 175 adolescents. It is not testing any specific intervention or drug.","completed","This observational study is looking at how body composition, lifestyle, and diet affect certain immune cells called meta-inflammatory monocytes (MiMos) in teenagers. Researchers believe that adolescents at risk for metabolic diseases like type 2 diabetes might have more active MiMos, which could lead to insulin resistance (when your body doesn't use insulin properly). The study aims to measure glucose (blood sugar) and insulin levels after you drink a sugary drink. You may be able to join if you are between 14 and 18 years old, have reached a mature stage of puberty, and have a normal, overweight, or obese weight, or pre-diabetes. The study is currently recruiting 175 participants.","Glucose and insulin levels will be measured at 120 minutes and 180 minutes after certain tests.",109,"This research study collects health-related information and blood samples.","Not stated in the trial record.",[],"v2"]