[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444280":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":55,"centralContacts":56,"locations":62,"responsibleParty":91,"collaborators":95,"id":101,"slug":55,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":55,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":123,"overallStatus":78,"whyStopped":55,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Seattle Children's Hospital","OTHER",[8,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin plus automated insulin delivery system","ACTIVE_COMPARATOR","Some participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with metformin and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG\u002FML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in addition to assessments of cardiovascular and endothelial function.",[13,14,15],"Drug: Metformin Hcl 1000Mg Tab","Drug: Aminohippurate Sodium 20 % Injection","Drug: Iohexol 300 Mg\u002FmL Injectable Solution",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo plus automated insulin delivery system","PLACEBO_COMPARATOR","Some participants with type 1 diabetes using an automated insulin delivery system will be randomized to receive treatment with a placebo pill which is identical in appearance to the metformin pill and will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG\u002FML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in addition to assessments of cardiovascular and endothelial function.",[14,15,21],"Drug: Placebo",{"label":23,"type":6,"description":24,"interventionNames":25},"Multiple daily insulin injections or manual insulin pump plus continuous glucose monitor","Participants with type 1 diabetes using multiple daily injections or an insulin pump in manual mode plus a continuous glucose monitor will not be randomized to receive medication treatment but will undergo RPF (Aminohippurate Sodium Injections 20%), GFR (Iohexol Inj 300 MG\u002FML), and insulin sensitivity (hyperinsulinemic-euglycemic clamp) assessments, in addition to assessments of cardiovascular and endothelial function.",[14,15],[27,37,45,51],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Metformin Hcl 1000Mg Tab","Agent used to modify insulin sensitivity",[9],[33,34,35,36],"Fortamet","Glucophage","Glumetza","Riomet",{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Aminohippurate Sodium 20 % Injection","Diagnostic aid\u002Fagent used to measure renal plasma flow and calculate renal vascular resistance",[9,23,17],[42,43,44],"Sodium 4-amino hippurate (PAH) injection 20% (2g\u002F10 mL)","Para-aminohippurate","Aminohippuric acid",{"type":28,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Iohexol 300 Mg\u002FmL Injectable Solution","Diagnostic aid\u002Fagent used to measure glomerular filtration rate",[9,23,17],[50],"Omnipaque 300",{"type":28,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Placebo","Identical to Metformin Hcl 1000Mg Tab but without metabolic effects",[17],null,[57],{"name":58,"role":59,"phone":60,"phoneExt":55,"email":61},"Kalie Tommerdahl, MD","CONTACT","(206) 616-9015","ktomme@uw.edu",[63,77],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":55},"Children's Hospital Colorado\u002FUniversity of Colorado Anschutz Medical Campus","ACTIVE_NOT_RECRUITING","Aurora","Colorado","80045","United States","US",{"type":72,"coordinates":73},"Point",[74,75],-104.83192,39.72943,{"lat":75,"lon":74},{"facility":5,"status":78,"city":79,"state":80,"zip":81,"country":69,"countryCode":70,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"RECRUITING","Seattle","Washington","98102",{"type":72,"coordinates":83},[84,85],-122.33207,47.60621,{"lat":85,"lon":84},[88,89],{"name":58,"role":59,"phone":60,"phoneExt":55,"email":61},{"name":58,"role":90,"phone":55,"phoneExt":55,"email":55},"PRINCIPAL_INVESTIGATOR",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"SPONSOR_INVESTIGATOR","Kalie Tommerdahl","Associate Professor of Pediatric Endocrinology",[96,99],{"name":97,"class":98},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",{"name":100,"class":6},"University of Colorado, Denver","100444280",false,"NCT05065372","MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes","MANATEE-T1D","Inclusion Criteria:\n\n* T1D and using an automated insulin delivery system or multiple daily insulin injections\u002Fmanual insulin pump plus continuous glucose monitor for \\> 6 months\n* Age 12-25 years\n* Use of an automated insulin delivery system or multiple daily insulin injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor for \\> 6 months\n* Hemoglobin A1c \\\u003C 11%\n* No recent episodes of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) (within 30 days)\n* Pubertal (Tanner stage ≥ 2)\n* Weight \\> 54 kg and BMI \\> 5th percentile for age and sex\n\nExclusion Criteria:\n\n* Blood pressure \\> 140\u002F90 mm Hg\n* Hemoglobin \\\u003C 9 g\u002FdL\n* Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2 or serum creatinine \\> 1.2 mg\u002FdL or history of urinary albumin to creatinine ratio ≥ 300mg\u002Fg or history of acute kidney injury\n* Use of anti-diabetic agents except insulin, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB's), diuretics, daily non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin, sulfonamides, procaine, thiazosulfone or probenecid\n* Seafood or iodine allergy\n* Pregnancy or breast feeding for females","ALL","12 Years","25 Years",{"count":111,"type":112},60,"ESTIMATED","INTERVENTIONAL",[115],"PHASE1","Diabetic kidney disease and cardiovascular disease remain the leading causes of morbidity and mortality in people with type 1 diabetes and are exacerbated with longer duration of diabetes and time outside goal glycemic range. Yet, type 1 diabetes is a complex disease with pathophysiology that extends beyond beta-cell injury and insulin deficiency to include insulin resistance and renal vascular resistance, factors that accelerate cardiovascular disease risk. We have shown that metformin improved peripheral insulin sensitivity and vascular stiffness in youth with type 1 diabetes on multiple daily insulin injections or standard insulin pumps. However, metformin's effect on kidney and endothelial outcomes, and the effects of type 1 diabetes technologies, with or without metformin, on any cardiovascular or kidney outcome, remains unknown. Automated insulin delivery systems combine an insulin pump, continuous glucose monitor, and control algorithm to modulate background insulin delivery and decrease peripheral insulin exposure while improving time in target range and reducing hypoglycemia. We hypothesize that automated insulin delivery systems, particularly when combined with metformin, may modulate renal vascular resistance and insulin sensitivity, thereby impacting cardiometabolic function. MANATEE-T1D is a randomized, double-blind, placebo-controlled trial of 4 months of metformin 2,000 mg daily in 40 youth aged 12-25 years with type 1 diabetes on automated insulin delivery systems vs. 20 control youth with type 1 diabetes on multiple daily injections plus a continuous glucose monitor or an insulin pump in manual mode plus a continuous glucose monitor which will assess for changes in calculated renal vascular resistance and gold standard measures of whole-body and adipose insulin sensitivity, arterial stiffness, and endothelial function.",[118,119,120,121,122],"Type 1 Diabetes","Diabetic Kidney Disease","Cardiovascular Diseases","Endothelial Dysfunction","Insulin Sensitivity",[124,125,126,127,128],"Type 1 diabetes","Youth","Insulin sensitivity","Cardiovascular function","Diabetic kidney disease","2025-06-10",{"date":131,"type":132},"2025-06-13","ACTUAL",{"date":134,"type":132},"2022-07-01",{"date":136,"type":112},"2027-07-31",{"name":93,"class":6},2]