[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"interventionName\":\"Insulin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":385},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,50,76,111,137,165,189,210,240,262,290,318,336,359],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100550351","phase-4-decide-a-comparative-effectiveness-trial-of-metformin-versus-insulin-for-the-treatment-of-gestational-diabetes-100550351",false,"NCT06445946","DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes","DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes","DECIDE","Inclusion Criteria:\n\n* Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.\n* Age 18 years or older\n* Gestational age at randomization between 20 0\u002F7 - 33 6\u002F7 weeks based on project gestational age.\n* GDM diagnosis less than or equal to 33 6\u002F7 weeks based on project gestational age.\n* Requires medication for glucose control defined as ≥ 30% elevated glucose values (either fasting or postprandial or both) prior to randomization per determination of the provider or documented in the medical record.\n* Patient willingness and ability to attend 2-year follow-up visit.\n\nExclusion criteria:\n\n* Renal disease (serum creatinine \\>1.3 mg\u002FdL) due to the potential impact of metformin on renal function.\n* Major structural malformation of the fetus.\n* Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.\n* Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and\u002For anaphylaxis.\n* For individuals with GDM diagnosed \\\u003C20 0\u002F7 weeks, documented A1c ≥\\>6.5% within prior 6 months.\n* Pregestational diabetes documented in the medical record or prior A1c\\>= 6.5%\n* Fasting hyperglycemia \\>115 mg\u002Fdl for ≥ 50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).\n* Enrolled in a trial that influences primary study outcomes (composite neonatal outcome at delivery or childhood body mass index at 2 years).\n* Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.\n* Language barrier (appropriate translation resources unavailable at the site)\n* Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.","FEMALE","18 Years",{"count":20,"type":21},1572,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This is a non-inferiority patient-centered and pragmatic comparative-effectiveness pregnancy randomized controlled trial (RCT) with postpartum maternal and child follow-up through 2 years of 1,572 individuals with gestational diabetes mellitus (GDM) randomized to oral metformin versus injectable insulin.\n\nThis study will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. A total of 1,572 pregnant individuals with GDM who need pharmacotherapy will be recruited at 20 U.S. sites using consistent treatment criteria to metformin versus insulin. Participants and their children will be followed through delivery to two years postpartum.",[27,28],"Gestational Diabetes Mellitus","Pregnancy, High Risk",[30,31,32,33,34,35,36],"Insulin","Pregnancy","Glycemic control","Metformin","Gestational diabetes","Diabetes","Adverse pregnancy outcomes","RECRUITING","2026-06-24",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":41},"2024-08-01",{"date":45,"type":21},"2030-12",{"name":47,"class":48},"Ohio State University","OTHER",24,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100569866","phase-4-modeling-ketosis-prone-diabetes-remission-via-diverse-mechanisms-of-glucotoxicity-100569866","NCT06699810","Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity","Inclusion Criteria:\n\n* Provide informed consent\n* Have a BMI ≥ 28 kg\u002Fm2\n* Be of African American ancestry\n* Meet diagnostic criteria for DKA. Diagnostic criteria for DKA will include a plasma glucose \\> 250 mg\u002Fdl, a venous pH \\\u003C 7.30, a serum bicarbonate \\\u003C 18 mmol\u002Fl, and serum ketones (beta-hydroxy butyrate) \\> 1.5 mmol\u002FL.\n\nExclusion Criteria:\n\n* Significant medical or surgical illness including but not limited to myocardial ischemia, congestive heart failure, chronic peripheral venous insufficiency, chronic renal insufficiency, liver insufficiency (serum transaminases 3 times the upper limit of normal) and acute or chronic infectious processes\n* Have recognized uncontrolled endocrine disorders such as hypercortisolism, acromegaly, or hyperthyroidism\n* Anemia (hemoglobin \\\u003C 12.5 g\u002FdL for men, \\\u003C11.5 gm\u002FdL for women), bleeding disorders, or abnormalities in coagulation studies\n* Pregnant\n* Diagnosis of diabetes \\> 90 days before the presentation of DKA\n* Unable to give consent","ALL",{"count":58,"type":21},12,[24],"The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.",[62],"Ketosis Prone Diabetes",[64,65],"diabetic ketoacidosis","type 2 diabetes","2026-06-12",{"date":68,"type":41},"2026-06-15",{"date":70,"type":41},"2025-01-23",{"date":72,"type":21},"2027-01",{"name":74,"class":48},"Emory University",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100628338","effects-of-cofrogliptin-on-beta-cell-function-in-lada-patients-100628338","NCT07460336","Effects of Cofrogliptin on Beta-Cell Function in LADA Patients","Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study","Inclusion Criteria:\n\n* 1\\. Voluntarily signed informed consent.\n* 2\\. Age 18 to 70 years, inclusive.\n* 3\\. Diagnosed with LADA, defined as meeting all of the following:\n* (1) Meets 1999 WHO criteria for diabetes mellitus.\n* (2) Age at diagnosis of diabetes ≥ 18 years.\n* (3) Positive for at least one islet autoantibody (GADA, IA-2A, or ZnT8A).\n* (4) Did not require continuous insulin therapy for at least 6 months after diagnosis.\n* 4\\. Stimulated C-peptide ≥ 200 pmol\u002FL.\n* 5\\. Glycated Hemoglobin (HbA1c) ≤ 9.0%.\n* 6\\. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study.\n\nExclusion Criteria:\n\n* 1\\. Pregnant, breastfeeding, or planning to become pregnant during the study.\n* 2\\. Gestational diabetes or other specific types of diabetes.\n* 3\\. Known hypersensitivity to Cogliptin, Vitamin D3, or their excipients.\n* 4\\. Use of DPP-4 inhibitors, GLP-1 receptor agonists, or thiazolidinediones (TZDs) within 8 weeks prior to randomization.\n* 5\\. Hypercalcemia (serum calcium above the upper limit of the normal range).\n* 6\\. Systemic corticosteroid therapy (oral or IV) for more than 7 consecutive days within 6 months prior to screening.\n* 7\\. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN), or total bilirubin \\> 2 times ULN.\n* 8\\. Estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m².\n* 9\\. History of acute diabetic complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state.\n* 10\\. History of pancreatitis or pancreatic surgery.\n* 11\\. New York Heart Association (NYHA) class III or IV congestive heart failure, or known left ventricular ejection fraction (LVEF) \\\u003C 40%.\n* 12\\. History of malignancy.\n* 13\\. Severe psychiatric illness.\n* 14\\. History of alcohol or illicit drug dependence.\n* 15\\. Any other severe systemic disease that the investigator deems unsuitable for enrollment.","70 Years",{"count":85,"type":21},84,[87],"NA","This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Following a screening period of up to 6 weeks, 84 eligible participants will be randomized in a 1:1 ratio via a sealed-envelope method, stratified by baseline GADA titer (≥0.3 vs \\\u003C0.3). Participants will be assigned to one of two treatment arms: (1) metformin (with or without insulin) plus vitamin D3, or (2) metformin (with or without insulin) plus vitamin D3 and cofrogliptin. Cofrogliptin will be administered orally at a dose of 10 mg once every 2 weeks, and vitamin D3 at 2000 IU once daily, for a total treatment duration of 52 weeks. Study visits are planned at baseline and at Weeks 12, 26, 38, and 52, during which mixed-meal tolerance tests (MMTT) and other protocol-specified assessments will be conducted.",[90],"Latent Autoimmune Diabetes in Adults (LADA)",[92,93,94,95,96,97,98,99],"LADA","Adult-Onset Autoimmune Diabetes","DPP-4 inhibitor","Beta-cell Function","Randomized Controlled Trial","C-peptide","Vitamin D3","Cofrogliptin","NOT_YET_RECRUITING","2026-05-05",{"date":103,"type":41},"2026-05-08",{"date":105,"type":21},"2026-05-15",{"date":107,"type":21},"2027-12-31",{"name":109,"class":48},"Second Xiangya Hospital of Central South University",1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":110},"100615523","phase-4-permissive-versus-strict-intrapartum-glucose-management-in-type-1-diabetes-prism-t1d-100615523","NCT07293715","Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)","PRISM-T1D","Inclusion Criteria\n\n* Pregnant individuals\n* ≥ 18 years old\n* Type 1 diabetes\n* Intention for vaginal delivery and admitted to Labor and Delivery\n* Singleton, non-anomalous fetus\n* Gestational age greater than or equal to 35 weeks gestation.\n* Cervical dilation is less than 6 cm.\n* Delivering at the study institution\n\nExclusion criteria:\n\n* Scheduled cesarean delivery\n* Cervical dilation ≥ 6 cm on presentation to L\\&D\n* Receipt of antenatal corticosteroids within 7 days of randomization\n* Fetal demise\n* Major fetal anomaly (attached)\n* Multiple gestation\n* Non-English speaking",{"count":119,"type":21},44,[24],"PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg\u002FdL) or strict (70-110 mg\u002FdL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.",[28,123],"Type 1 Diabetes",[31,125,123,126,127,128],"Continuous Glucose Monitor","Automated insulin delivery","Hybrid closed loop","Insulin pump","2026-04-28",{"date":131,"type":41},"2026-04-29",{"date":133,"type":41},"2026-02-25",{"date":135,"type":21},"2027-06",{"name":47,"class":48},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":110},"100635154","phase-2-open-label-study-of-dimethyl-fumarate-in-adults-with-type-1-diabetes-100635154","NCT07548996","Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes","Non-Randomized, Parallel-Controlled, Single-Center, Open-Label Clinical Trial Evaluating the Efficacy and Safety of Dimethyl Fumarate in Preserving Pancreatic β-Cell Function in Adults With Type 1 Diabetes","Inclusion Criteria:\n\n* Willing and able to participate in the study and provide signed informed consent\n* Aged 18 to 65 years\n* Diagnosed with type 1 diabetes mellitus according to ADA 2024 criteria\n* Positive for at least 2 islet autoantibodies among insulin autoantibody (IAA), glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), islet cell antibody (ICA), and zinc transporter 8 autoantibody (ZnT8A)\n* Random C-peptide level greater than or equal to 200 pmol\u002FL\n\nNote:\n\n\\- For participants who have used insulin for more than 14 days, a positive IAA result must be accompanied by at least 2 additional positive autoantibodies other than IAA\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, positive urine pregnancy test at screening, or inability to rule out pregnancy in the opinion of the investigator\n* Good glycemic control with oral antidiabetic drugs alone\n* Participation in other studies involving diabetes treatment or immunomodulation\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal\n* Renal insufficiency or evidence of kidney damage, including estimated glomerular filtration rate (eGFR) less than 60 mL\u002Fmin\u002F1.73 m², urinary albumin-to-creatinine ratio (UACR) greater than or equal to 3.4 mg\u002Fmmol (repeat confirmation if necessary), or other kidney disease considered unsuitable for enrollment by the investigator\n* History of malignancy, uncontrolled immune system disease, or uncontrolled infection\n* Alcohol abuse, drug abuse, psychiatric disorder, or other conditions considered unsuitable for participation in a drug trial\n* Use of other immunosuppressive agents within 12 weeks before enrollment\n* Participation in any other drug trial within 12 weeks before enrollment\n* History of multiple drug allergies, allergic diseases, hypersensitivity constitution, or drug dependence\n* Any disease or condition that, in the opinion of the investigator, may interfere with study participation or evaluation","65 Years",{"count":146,"type":21},96,[148,149],"PHASE2","PHASE3","This is a non-randomized, parallel-controlled, single-center, open-label clinical trial designed to evaluate the efficacy of dimethyl fumarate in preserving pancreatic beta-cell function in adults with type 1 diabetes, as well as its safety and tolerability in this population.\n\nEligible participants are adults aged 18 to 65 years who meet the ADA 2024 diagnostic criteria for type 1 diabetes, have at least 2 positive islet autoantibodies, and have residual beta-cell function as evidenced by a random C-peptide level of at least 200 pmol\u002FL. A total of 96 participants are planned for enrollment, including 32 in the dimethyl fumarate treatment group and 64 in the standard-treatment control group.\n\nParticipants in the treatment group will receive dimethyl fumarate enteric-coated capsules in addition to standard insulin therapy for type 1 diabetes. Dimethyl fumarate will be initiated at 120 mg twice daily and increased after 7 days to a maintenance dose of 240 mg twice daily. Participants in the control group will receive standard insulin therapy alone. The intervention period will be 24 weeks, followed by 52 weeks of follow-up.\n\nThe primary efficacy endpoint is the baseline-adjusted geometric mean area under the serum C-peptide curve during a 2-hour mixed-meal tolerance test at Week 24. Secondary endpoints include measures of beta-cell function at multiple time points, changes in glycated hemoglobin, proportions of participants with good or poor glycemic control, insulin dose requirements, and immunologic markers including lymphocyte subsets, cytokine profiles, and islet autoantibody characteristics. Safety assessments will include the incidence of flushing, gastrointestinal adverse events, allergic reactions, opportunistic infections, liver function abnormalities, lymphopenia, renal abnormalities, hypoglycemia, severe hypoglycemia, ketosis, and ketoacidosis.\n\nThe total study duration is 36 months, from January 2026 to December 2028.",[152],"Type 1 Diabetes Mellitus",[154,123,155],"Dimethyl Fumarate","Beta-Cell Function","2026-04-21",{"date":158,"type":41},"2026-04-23",{"date":160,"type":21},"2026-04-27",{"date":162,"type":21},"2028-12-31",{"name":164,"class":48},"Nanjing Medical University",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":172,"sex":56,"minAge":18,"maxAge":144,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":110},"100546278","early-phase-1-regional-lipolysis-insulin-regulation-100546278","NCT06392854","Regional Lipolysis Insulin Regulation","Insulin Regulation of Regional Lipolysis","Inclusion Criteria:\n\n* Males and females 18-65years who are able to comprehend instructions, follow study procedures and who willing to provide written, informed consent will be included. The volunteers will consume an isoenergetic diet eating all meals from Mayo Clinical Research Trials Unit (CRTU) for 3 days prior to study.\n* Overweight\u002FObese volunteers will have a BMI 29.0 - 37.0 kg\u002Fm2\n\n  * Upper body\u002Fvisceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \\> 0.85 and\u002For increased visceral fat by single slice CT scan, usually with \\> 120 cm2 of visceral fat by CT scanning or a visceral fat\u002Ftotal fat ratio of \\> 0.30, and\u002For biochemical evidence of metabolic syndrome as defined by ATP III criteria (fasting plasma triglycerides ≥ 150 mg\u002FdL, HDL-cholesterol \\< 50 mg\u002FdL for women and \\< 40 mg\u002FdL for men, fasting plasma glucose ≥ 100 mg\u002FdL). Upper body obesity in men will be defined as a waist-hip ratio of \\>0.95 and\u002For increased visceral fat (visceral fat area \\> 180 cm2 or a visceral\u002Ftotal fat abdominal ratio by CT of \\> 0.40) by single slice CT scan and\u002For biochemical evidence of metabolic syndrome as defined by adenosine triphosphate (ATP) III criteria. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.\n  * Lower body obesity (LBO) in women will be defined as a waist-hip ratio of \\<0.75 and\u002For a lower visceral fat by single slice CT scan, usually \\< 120 cm2 or a visceral fat\u002Ftotal fat ratio of ≤ 0.30 and fasting plasma triglycerides within the normal range. The term \"lower body men\" is used to describe a male phenotype that is characteristic of adipose insulin sensitivity even with excess body fat. A waist to hip ratio isn't suitable for this description as it is for women. LBO men will be defined as obese men with normal fasting plasma triglycerides, normal fasting plasma glucose and greater proportional leg fat via dual-energy x-ray absorptiometry (DEXA).\n* Female subjects are eligible if they meet the following criteria:\n\n  * Are not pregnant or nursing.\n  * All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test day of admission for inpatient study visit.\n\nExclusion Criteria:\n\n* Individuals with a history of a disease process such as:\n\n  * Ischemic heart disease\n  * Atherosclerotic valvular disease\n  * Persistent blood pressure greater than 160\u002F95 despite antihypertensive medication\n* Smokers\n* Diagnosis Diabetes Mellitus\n* Concomitant use of medications that can alter free fatty acid metabolism, including, but not limited to niacin, thiazolidinediones, beta-blockers, oral or injected corticosteroids or anabolic steroids.\n* Allergy to lidocaine\n* Allergy to indocyanine green.",true,{"count":174,"type":21},48,[176],"EARLY_PHASE1","Adults who gain most of their excess weight in the abdominal area typically do not respond to insulin in the same way as lean adults. Researchers are trying to understand why fat tissue responds differently in people with different body types.",[179],"Obesity","2026-04-07",{"date":182,"type":41},"2026-04-13",{"date":184,"type":41},"2024-05-01",{"date":186,"type":21},"2028-06",{"name":188,"class":48},"Mayo Clinic",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":144,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":110},"100574671","phase-2-efficacy-and-safety-of-empagliflozin-or-semaglutide-in-overweightobese-patients-with-type-1-diabetes-100574671","NCT06762314","Efficacy and Safety of Empagliflozin or Semaglutide in Overweight\u002FObese Patients With Type 1 Diabetes","Comparative Clinical Study to Evaluate the Efficacy and Safety of Empagliflozin or Semaglutide in Overweight\u002FObese Patients With Type 1 Diabetes Inadequately Controlled by Insulin Therapy","Inclusion Criteria:\n\n* patients diagnosed with type 1 diabetes for more than 1 year.\n* Age 18-65 years.\n* BMI ≥ 27 kg\u002Fm².\n* HbA1c 7.5-10 % (58-86 mmol\u002Fmol)\n* Inadequately controlled despite treatment with multiple daily injections of insulin for at least 1 year.\n\nExclusion Criteria:\n\nHistory of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) syndrome; family history of multiple endocrine neoplasia, type 2A (MEN 2A), medullary thyroid cancer, or familial medullary thyroid cancer.\n\n* Insulin pump treatment.\n* Any prior use of GLP-1 RAs or dipeptidyl peptidase-4 inhibitors, any medication (except insulin) that could interfere with glycemic control or affect a subject's safety.\n* An estimated glomerular filtration rate ≤ 30 mL\u002Fmin\u002F1.73 m2.\n* Liver disease with raised alanine aminotransferase (AST), aspartate transaminase (ALT) or alkaline phosphatase (ALP)more than three times the upper normal range.\n* History of pancreatitis.\n* Gastroparesis.\n* Pregnancy or lactation.\n* History of alcohol or drug misuse, or any medical or psychological disorder that made the patient unsuitable for study participation.\n* Acute symptomatic urinary tract infection or genital infection; chronic or recurrent (≥3 annual episodes) cystitis.\n* Hypoglycaemia that required hospitalization or emergency treatment in the 3 months.\n* DKA that required hospitalization or emergency treatment in the past 12 months.\n* Treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen leading to unstable body weight (based on Investigator's judgement) for the last 3 months.",{"count":197,"type":21},105,[148],"Type 1 Diabetes (T1DM) is a disease characterised by immune mediated destruction of the insulin-producing pancreatic beta cells. Overtime, obvious insulin deficiency develops which requires insulin therapy. T1DM accounts for about 5% to 10% of diabetes cases in Europe and United States. Currently, worldwide incidence is estimated to be around 15 per 100,000 people per year. Despite the advancement that has occurred in the field diabetes therapy, patient with T1DM still suffer from managing their disease as well as continuing to face diabetes related complications. The American Diabetes Association (ADA) recommend a goal of glycated haemoglobin (HbA1c) of \\\u003C 7%. However, only 21% of adults in the United States has achieved this recommended goal. Once again, a multinational, multicentre study shows that only 24.3% of participants achieved the glycaemic target of HbA1c less than 7.0 %. Unfortunately, intensifying the insulin therapy in order to reach the targeted HbA1c can result in serious adverse effects of hypoglycaemia and weight gain which is in its turn is known risk factor for cardiovascular disease.",[35],"2026-03-12",{"date":203,"type":41},"2026-03-13",{"date":205,"type":41},"2025-01-20",{"date":207,"type":21},"2028-11-20",{"name":209,"class":48},"Mostafa Bahaa",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":221,"phases":4,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":110},"100459105","glycemic-variations-during-the-menstrual-cycle-in-women-with-type-1-diabetes-100459105","NCT05258292","Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes","Glycemic Variations During the Menstrual Cycle in Women With Type 1 Diabetes: the GLYMETY Study","GLYMETY","Inclusion Criteria:\n\n1. Females aged 18 to 50 living in Canada.\n2. Clinical diagnosis of type 1 diabetes or latent autoimmune diabetes in adults (LADA) for at least one year.\n3. Using insulin pump therapy, multiple daily injections or automated insulin delivery systems for at least 3 months.\n4. Using a continuous glucose monitoring (CGM) system.\n5. Having at least one menses in the last 40 days.\n6. Accepting to share CGM data with the research team and if applicable insulin pump data.This access will be limited to the study period.\n7. Having a smartphone or tablet to follow menstrual cycles.\n8. Stable weight (less than 5% variation in the last 3 months).\n\nExclusion Criteria:\n\n1. Using a hormonal contraception method that eliminates menses (Depo Provera, progestin intrauterine device, extented-cycle regimen with birth control pill)\n2. Using regular insulin (Entuzity U500, Novolin ge Toronto or Humulin R).\n3. Clinically significant nephropathy (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2, planned or on dialysis) or neuropathy (e.g., known uncontrolled gastroparesis) as judged by the investigator.\n4. Recent (\\\u003C 6 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery).\n5. Anticipated therapeutic change (including change of insulin type and\u002For type of CGM sensor, insulin pump or AID (automated insulin device) system) between admission and end of the study.\n6. Anticipated change in contraception method or plan to begin or stop a contraceptive method.\n7. Anticipated need to use acetaminophen during the study period at a dose above 1g every 6 hours.\n8. Pregnancy (ongoing or current attempt to become pregnant)\n9. Breastfeeding\n10. Uncontrolled thyroid disease (TSH should be in target range and treatment stable for at least 6 weeks).\n11. Severe hypoglycemic episode within two weeks of screening\n12. Severe hyperglycemic episodes requiring hospitalization in the last 3 months.\n13. Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)\n14. Agents affecting gastric emptying (Motilium®, Victoza®, Ozempic®, Trulicity®, Byetta® and Symlin®) as well as oral anti-diabetic agents (Metformin, Prandase®, DPP-4 inhibitors) unless at a stable dose for 3 months and without anticipated change during the study.\n15. Current use of SGLT-2 inhibitors unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed.\n16. Other serious medical illnesses which likely interfere with study participation or with the ability to complete the study by the judgment of the investigator.\n17. Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change).\n18. Anticipated radiologic examination incompatible with CGM wear for more than 10 days between admission and end of the study (e.g., repeated MRI).\n19. In the opinion of the investigator, a participant who is unable or unwilling to complete the study.\n20. If taking medication for hypothyroidism, no change of dose (Levothyroxin) in the last 6 weeks.","50 Years",{"count":220,"type":21},86,"OBSERVATIONAL","In clinical practice, women living with type 1 diabetes frequently report that insulin requirements change across the menstrual cycle. Consequently, glycemic fluctuations are observed. This phenomenon could be explained by a decrease in insulin sensitivity during the second half of the menstrual cycle (luteal phase).\n\nOverall, despite an important proportion of women reporting glycemic and\u002For insulin variations across the menstrual cycle, studies to date have involved small sample sizes, and have had inconsistent results. The objective of this study will be to study glycemic fluctuations across the menstrual cycle using CGM data, alongside insulin data, in a large sample of women.",[224],"Type1diabetes",[226,227,228,229,230],"Menstrual cycle","Continuous glucose monitoring","Insulin dose","Physical activity","Food intake","2026-03-03",{"date":233,"type":41},"2026-03-05",{"date":235,"type":41},"2022-05-02",{"date":237,"type":21},"2026-05-31",{"name":239,"class":48},"Institut de Recherches Cliniques de Montreal",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":218,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":110},"100576167","phase-4-gdm-insulin-with-or-without-metformin-100576167","NCT06781775","GDM: Insulin with or Without Metformin?","Gestational Diabetes Treatment: Should We Continue Metformin When Starting Insulin? a Randomized Control Trial","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Pregnant female meeting diagnosis for gestational diabetes requiring medical treatment\n4. Ability to take oral medication and be willing to adhere to the metformin regimen\n5. Willing to take insulin if needed\n6. Willing to take blood sugars 4 times per day\n\n   \\-\n\n   Exclusion Criteria:\n   * 1\\) Metformin allergy or known intolerance, known hypersensitivity to insulin 2) Severe hepatic dysfunction 3) Chronic kidney disease 4) Pregnancy with major fetal anomalies 5) Non-viable pregnancy",{"count":248,"type":21},130,[24],"This will be a randomized trial of patients with gestational diabetes who start hypoglycemic therapy with metformin but eventually require insulin. It will examine whether continuing metformin when adding insulin versus discontinuing metformin when insulin is added is beneficial. The investigators hypothesize that continuing metformin will reduce the needed insulin dosage and improve maternal and neonatal outcomes in these patients.",[252],"Gestational Diabetes","2025-01-13",{"date":255,"type":41},"2025-01-17",{"date":257,"type":41},"2024-12-12",{"date":259,"type":21},"2027-05-01",{"name":261,"class":48},"University of Virginia",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":56,"minAge":269,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":279,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":286,"leadSponsor":288,"locationsCount":110},"100562279","phase-3-effects-of-topical-insulin-on-corneal-epithelium-healing-after-corneal-crosslinking-in-patients-with-keratoconus-100562279","NCT06601101","Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus","Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients with a diagnosis of keratoconus, indicated for corneal crosslinking\n\nExclusion Criteria:\n\n* Diabetes Mellitus\n* Severe dry eye\n* Limbal Stem Cell Deficiency\n* Glaucoma\n* Insulin or methylcellulose allergy","14 Years",{"count":271,"type":21},36,[149],"The cornea plays a fundamental role in vision, being a complex tissue essential for ocular health. In ophthalmological practice, there are situations such as corneal crosslinking, where damage to the corneal epithelium occurs. Crosslinking is a surgical procedure aimed at strengthening collagen bonds in the corneal stroma to prevent the progression of keratoconus, through the application of topical riboflavin followed by ultraviolet (UV-A) radiation. To enhance the effectiveness of riboflavin and UV-A radiation, the corneal epithelium needs to be removed, which can cause postoperative pain and discomfort, as well as increase the risk of complications such as infections, scarring, corneal opacities, perforations, and recurrent epithelial erosions. Several growth factors play a role in epithelial healing, and the discovery of insulin in the tear film and the presence of insulin and Insulin-Like Growth Factor (IGF-1) receptors in the cornea has raised the hypothesis that insulin may modulate the cornea's wound healing response. Since then, topical insulin has been used for various ocular pathologies, including dry eye disease, persistent epithelial defects, and neurotrophic ulcers. Based on this knowledge, studies have been developed, and promising results regarding the use of insulin in corneal healing have been reported, providing a scientific foundation for the realization of this project. The objective of this study is to evaluate the effect of insulin eye drops at a concentration of 50 IU\u002Fml on epithelial healing in non-diabetic patients undergoing epithelial debridement for corneal crosslinking. To this end, a randomized, double-masked clinical trial will be conducted with two groups, one being the control group, in which researchers will compare the epithelial healing rate in mm²\u002Fh between the insulin group and the placebo group, as the primary outcome. Patients diagnosed with keratoconus and with an indication for the crosslinking procedure, will be invited to participate. As a result of the study, it is expected to assess and quantify the impact of topical insulin on epithelial defect closure in patients undergoing crosslinking, compared to placebo. Topical insulin may contribute to early epithelial defect closure, control of inflammation, and prevention of complications that could significantly impact visual quality.",[275,276,277,278],"Keratoconus","Cornea Disease","Eye Diseases","Wound Heal",[280,281],"Topical Insulin","Crosslinking","2025-01-10",{"date":284,"type":41},"2025-01-14",{"date":43,"type":41},{"date":287,"type":21},"2025-10-01",{"name":289,"class":48},"University of Campinas, Brazil",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":172,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":75},"100548346","strict-versus-permissive-thresholds-for-initiation-of-pharmacotherapy-in-gestational-diabetes-start-2-100548346","NCT06419803","Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)","Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Continuous Glucose Monitoring Use - A Randomized Control Trial (START 2 Trial)","START2","Inclusion Criteria:\n\n* Live, non-anomalous fetus\n* Literacy in English, Spanish, Mandarin, or Arabic\n* Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.\n\nExclusion Criteria:\n\n* \\\u003C18 years at EDD\n* pre-existing diabetes or diagnosis of GDM prior to 24 weeks\n* multi-fetal gestation\n* known major fetal anomaly\n* known allergy to insulin\n* chronic maternal corticosteroid use\n* diagnosis of GDM based on finger sticks alone\n* patients who have contraindication to oral glucose tolerance test\n* a primary language other than English, Spanish, Mandarin, or Arabic",{"count":299,"type":21},430,[87],"The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg\u002FdL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg\u002FdL, with target time in range goal of 70%.",[252,303],"Pregnancy Related",[305,306,307,308],"gestational diabetes","pregnancy","insulin","Initiation of medication","2024-11-19",{"date":311,"type":41},"2024-11-22",{"date":313,"type":41},"2024-09-01",{"date":315,"type":21},"2026-05",{"name":317,"class":48},"Thomas Jefferson University",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":172,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":334,"leadSponsor":335,"locationsCount":75},"100548344","strict-versus-permissive-thresholds-for-initiation-of-pharmacotherapy-in-gestational-diabetes-100548344","NCT06419777","Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes","Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)","START 1","Inclusion Criteria:\n\n* Live, non-anomalous fetus\n* Literacy in English, Spanish, Mandarin, or Arabic\n* Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.\n\nExclusion Criteria:\n\n* \\\u003C18 years at EDD\n* pre-existing diabetes or diagnosis of GDM before 24 weeks\n* multi-fetal gestation\n* known major fetal anomaly\n* known allergy to insulin\n* chronic maternal corticosteroid use\n* diagnosis of GDM based on finger sticks alone\n* patients who have contraindication to oral glucose tolerance test\n* a primary language other than English, Spanish, Mandarin, or Arabic",{"count":299,"type":21},[87],"The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).",[252,303],[305,306,307,308],{"date":332,"type":41},"2024-11-21",{"date":313,"type":41},{"date":315,"type":21},{"name":317,"class":48},{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":4,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":22,"phases":345,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":110},"100517424","phase-4-clinical-trial-to-determine-the-efficacy-and-safety-of-insulin-eye-drops-in-dry-eye-in-patients-with-topical-hypotensors-100517424","NCT06017362","Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors","Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Hipotensores Tópicos","Inclusion Criteria:\n\n* Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.\n* Patients ≥ 18 years at the screening visit.\n* Ocular hypertension or glaucoma controlled with hypotensive treatment\n* Diagnosis of dry eye\n\nExclusion Criteria:\n\n* Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months\n* Changes in topical glaucoma treatment in the last 3 months\n* Severe dry eye requiring immediate treatment\n* Previous eye surgery, except cataract surgery more than 12 months ago\n* Laser procedures less than 6 months ago\n* Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days\n* Eyelid disorders\n* Use of contact lenses\n* Other topical treatment other than dry eye and glaucoma\n* Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients\n* Modifications in systemic immunosuppressive treatment in the last 6 months\n* History of alcohol or drug abuse\n* Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.\n* Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).\n* Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.",{"count":344,"type":21},100,[24],"The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears).\n\nThe main question aims to answer whether glaucoma patients treated with topical hypotensors could benefit from the use of insulin eye drops for the treatment of dry eye.\n\nParticipants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).",[348,349],"Dry Eye","Glaucoma","2024-10-18",{"date":352,"type":41},"2024-10-22",{"date":354,"type":41},"2023-02-08",{"date":356,"type":21},"2026-02-08",{"name":358,"class":48},"Barbara Burgos Blasco",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":172,"sex":17,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":22,"phases":369,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":110},"100440058","insulin-sensitivity-after-breast-cancer-100440058","NCT05010356","Insulin Sensitivity After Breast Cancer","Study of Molecular Causes of Metabolic Disorders in Obese Premenopausal Women After Breast Cancer","Inclusion Criteria:\n\n* Premenopausal women operated for breast cancer and after completing adjuvant chemotherapy and no earlier than 3 weeks after its termination\n* BMI: 25-30\n* Healthy controls will be included matched by gender, weight, age, and level of physical activity to the patient group included as subjects\n\nExclusion Criteria:\n\n* Known postmenopause occurred at the time of diagnosis of breast cancer\n* Alcohol intake of\\> 7 items \u002F week\n* Smoker\n* Already known Type 2 diabetes mellitus or metabolic syndrome and medical treatment thereof.\n* Cardiovascular disease and its medical treatment\n* Impaired mobility","20 Years","45 Years",{"count":49,"type":21},[87],"Epidemiological studies have revealed that 60-80% of women with breast cancer (BC) develop metabolic disorders that are similar to those observed in conditions like type 2 diabetes. These metabolic disorders, including insulin resistance, obesity, hyperinsulinemia, and glucose intolerance, are associated with increased BC recurrence and mortality. Skeletal muscle is the major site of glucose uptake in humans. The aims of the present project are to 1) determine the involvement of insulin resistance in skeletal muscle in the metabolic disorders prevalent in BC survivors, 2) identify BC-and\u002For treatment-induced molecular changes in skeletal muscle from BC survivors .",[372,373,374,375],"Insulin Sensitivity\u002FResistance","Breast Cancer","Survivorship","Metabolic Disturbance","2021-08-10",{"date":378,"type":41},"2021-08-18",{"date":380,"type":21},"2021-08",{"date":382,"type":21},"2026-09",{"name":384,"class":48},"University of Copenhagen",""]