[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647012":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":51,"locations":61,"responsibleParty":90,"collaborators":94,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":36,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":36,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":64,"whyStopped":36,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,15,20,26],{"label":9,"type":10,"description":11,"interventionNames":12},"1. Intervention group (nutrition therapy + myo-inositol + folic acid)","EXPERIMENTAL","Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the investigational supplement myo-inositol plus folic acid.",[13,14],"Dietary Supplement: Myo-inositol 2 g + Folic acid 200 µg","Behavioral: Nutrition therapy",{"label":16,"type":10,"description":17,"interventionNames":18},"2. Intervention group (insulin therapy + myo-inositol + folic acid)","Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the investigational supplement myo-inositol plus folic acid.",[13,19],"Drug: Insulin therapy",{"label":21,"type":22,"description":23,"interventionNames":24},"3. Control group (nutrition therapy + folic acid)","ACTIVE_COMPARATOR","Women who maintain their blood glucose levels within the normal range through nutritional therapy and receive the supplement folic acid.",[25,14],"Dietary Supplement: Folic acid 200 µg",{"label":27,"type":22,"description":28,"interventionNames":29},"4. Control group (inuslin therapy + folic acid)","Women who are already receiving insulin therapy to maintain their blood glucose levels within the normal range and receive the supplement folic acid.",[25,19],[31,37,41,46],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DIETARY_SUPPLEMENT","Myo-inositol 2 g + Folic acid 200 µg","This dietary supplement contains 2 g of myo-inositol and 200 µg folic acid per capsule. It should be taken twice a day (à 3 capsules) with fluid intake and a meal.",[9,16],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Folic acid 200 µg","This dietary supplement contains 200 μg of folic acid per capsule and should also be taken twice a day (à 1 capsule) with adequate fluid intake and a main meal.",[21,27],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":36},"DRUG","Insulin therapy","Women with GDM who maintain their blood glucose levels with insulin therapy.",[16,27],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":36},"BEHAVIORAL","Nutrition therapy","Women with GDM who maintain their blood sugar levels with nutritional therapy.",[9,21],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":36,"email":56},"Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc","CONTACT","+43 1 404 00-60950","michael.leutner@meduniwien.ac.at",{"name":58,"role":54,"phone":59,"phoneExt":36,"email":60},"Ricarda Rosalia Baron, MSc, Msc","+43 1 404 00-20690","Ricarda.Baron@meduniwien.ac.at",[62,80],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna","RECRUITING","Vienna","State of Vienna","1090","Austria","AT",{"type":71,"coordinates":72},"Point",[73,74],16.37208,48.20849,{"lat":74,"lon":73},[77],{"name":78,"role":54,"phone":79,"phoneExt":36,"email":60},"Ricarda Rosalia Baron Baron, MSc","+ 43 40400 20690",{"facility":5,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},{"type":71,"coordinates":82},[73,74],{"lat":74,"lon":73},[85,87],{"name":53,"role":54,"phone":55,"phoneExt":36,"email":86},"Michael.Leutner@meduniwien.ac.at",{"name":88,"role":89,"phone":36,"phoneExt":36,"email":36},"Ricarda Rosalia Baron, MSc, MSc","SUB_INVESTIGATOR",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Michael Leutner","Priv.Doz. Dr.med.univ.",[95],{"name":96,"class":97},"BIOGENA GmbH, Salzburg","UNKNOWN","100647012","the-impact-of-myo-inositol-on-glycemic-control-and-oxidative-stress-in-gestational-diabetes-mellitus-100647012",false,"NCT07685015","The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus","The Impact of Myo-Inositol Supplementation on Glycemic Control and Oxidative Stress in Women With Gestational Diabetes Mellitus: A Randomized, Open-Label Pilot Study","Inclusion Criteria:\n\n* GDM diagnosis\n* at least one of the HAPO-Study criteria: 2h-oGTT → \\>153 mg\u002Fdl, 1h-oGGT → \\>180 mg\u002Fdl, fasting plasma glucose \\> 92 mg\u002Fdl\n* age between 18-45\n* single pregnancy\n\nExclusion Criteria:\n\n* T2DM\n* T1DM\n* Maturity Onset Diabetes of the Young (MODY)\n* Latent Autoimmune Diabetes in Adults (LADA)\n* pre pregnancy BMI \\>35\n* oral antidiabetic drugs\n* pre-existing renal disease\n* heart disease and other chronic medical disorders\n* allergies to any ingredients contained in the dietary supplements","FEMALE","18 Years","45 Years",{"count":109,"type":110},40,"ESTIMATED","INTERVENTIONAL",[113],"NA","The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM).\n\nThe study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery.\n\nThe intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments.\n\nBlood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these periods.\n\nThree study visits are planned, during which the following assessments will be conducted. To determine the primary outcome, \"time in range (TIR)\" (time spent within the target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed.\n\nAdditionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.",[116],"Gestational Diabetes Mellitus (GDM)",[118,119,120,121,122,123,124,125,126,127,128,129],"Gestational Diabetes Mellitus","GDM","Myo-Inositol","Continous Glucose Monitoring","CGM","Oxidative Stress","Inflammation","Glycemic Control","Inositol","MYO","MI","Pregnancy","2026-07-02",{"date":132,"type":133},"2026-07-06","ACTUAL",{"date":135,"type":133},"2026-03-23",{"date":137,"type":110},"2027-07-01",{"name":5,"class":6},2]