[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glucose-intolerance-during-pregnancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glucose-intolerance-during-pregnancy":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,65,98,126,155,185,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":45,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100634052","early-pregnancy-lifestyle-and-glucose-patterns-a-substudy-of-tofffy-100634052",false,"NCT07534670","Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY","Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY","Inclusion Criteria:\n\n* Enrolled in the Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) (NCT06293235)\n* Females who are currently pregnant and with viable intrauterine pregnancy at ≤13 weeks gestation at enrolment\n\nExclusion Criteria:\n\n* Females with pre-existing diabetes mellitus (Type 1 or Type 2) and\u002For chronic medical conditions affecting glucose metabolism\n* Females who are taking medications known to significantly affect glucose metabolism\n* Females with multiple pregnancy (e.g., twins or higher-order gestation)\n* Females who are unable to comply with study procedures, including: Inability to use smartphone-based applications and inability to wear wrist actigraphy device",true,"FEMALE","21 Years","39 Years",{"count":21,"type":22},140,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes.\n\nThe main questions it aims to answer are:\n\n1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)?\n2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)?\n3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care?\n\nThis study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care).\n\nParticipants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Continuous Glucose Monitoring","Diabetes, Gestational","Diet During Pregnancy","Meal Time","Actigraphy","Pregnancy","Glucose Intolerance During Pregnancy","Gestational Diabetes Mellitus in Pregnancy","Circadian Rhythm","Sleep","Chronobiology","Wearable Electronic Devices","Mobile Applications","Blood Glucose Profile","Metabolic Diseases","Randomized Controlled Trial","Pilot Study",[46,47,48,49,50,51],"Risk factor","Lifestyle","Early pregnancy","Chrono-disruptive behaviours","Maternal health","Lifestyle intervention","NOT_YET_RECRUITING","2026-04-22",{"date":55,"type":56},"2026-04-27","ACTUAL",{"date":58,"type":22},"2026-05-01",{"date":60,"type":22},"2027-06-30",{"name":62,"class":63},"KK Women's and Children's Hospital","OTHER_GOV",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":16,"sex":17,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":64},"100558262","effects-of-a-non-nutritive-sweetener-reduction-intervention-in-pregnancy-and-lactation-on-maternal-and-infant-outcomes-100558262","NCT06548828","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes","Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes (the SweetPea Trial)","Inclusion Criteria:\n\n* Pregnant\n* ≤ 16 weeks gestation\n* Singleton pregnancy\n* Report frequent NNS beverage consumption (≥ 7 servings\u002Fweek)\n* 18-45 years of age\n* Able to read English at a 5th grade level; and\n* Intend to breastfeed for at least the first 6 months of life.\n* For infants: The mother must be enrolled and provide assent for the infant to participate.\n\nExclusion Criteria:\n\n* Physical or mental concerns preventing study participation;\n* Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;\n* Tobacco or drug use during pregnancy;\n* Alcohol consumption (\\>1 drink per week) during pregnancy;\n* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;\n* Known suspected\u002Fconfirmed genetic fetal abnormalities or suspected or known congenital birth defects.\n* History of prior gastric bypass surgery.","18 Years","45 Years",{"count":75,"type":22},324,[25],"The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and\u002For lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.",[35,34,79],"Non-nutritive Sweeteners Consumption in Pregnancy and\u002For Lactation",[81,33,82,83,84,85,86],"Non-nutritive sweeteners (NNS)","Lactation","Infant fat mass","Gestational diabetes (GDM)","Glucose tolerance","PeaPod","RECRUITING","2026-02-16",{"date":90,"type":56},"2026-02-18",{"date":92,"type":56},"2024-08-19",{"date":94,"type":22},"2029-02-01",{"name":96,"class":97},"George Washington University","OTHER",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":72,"maxAge":73,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100558638","effects-of-vitamin-d-and-prebiotic-supplementation-on-glucose-control-during-pregnancy-100558638","NCT06553729","Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy","Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n1. 6-15 weeks of gestation.\n2. Age 18-45 years old.\n3. Permanent resident or resident locally at least one year.\n4. GDM high-risk pregnant women (meeting any of the following criteria):\n\n   1. Pre-pregnancy body mass index (BMI) ≥24.0 kg\u002Fm2,\n   2. History of GDM or a family history of diabetes,\n   3. History of delivery of macrosomia (birth weight \\>4000 g),\n   4. HbA1c 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol\u002FL.\n\nExclusion Criteria:\n\n1. Multiple pregnancy.\n2. Have received infertility treatment such as in vitro fertilization or intrauterine insemination.\n3. History of diabetes or current diagnosis of diabetes (including type 1 and type 2 diabetes) or abnormal glucose tolerance at recruitment (fasting blood glucose \\>7.0 mmol\u002FL or HbA1c≥6.5%).\n4. Serious chronic diseases (including cardiovascular and cerebrovascular diseases, cancer, and thyroid dysfunction) or infectious diseases (including hepatitis B, active tuberculosis, acquired immunodeficiency syndrome, and syphilis).\n5. Severe liver disease (such as cirrhosis) or severe kidney disease (such as renal failure or requiring dialysis).\n6. Kidney stones, hypercalcemia, hypercalciuria, parathyroid hormone abnormality.\n7. Any mental disorders, such as schizophrenia, depression, other mental disorders, or bipolar disorder.\n8. History of allergy or intolerance to vitamin D, chicory root, or starch.\n9. Have participated in or are participating in other clinical trials within the past 3 months.\n10. Daily vitamin D intake \\>800 IU.\n11. Inability or refusal to answer and communicate.\n12. Those who are unwilling to sign the informed consent.\n13. The researcher thinks that it is not suitable to participate in this research.",{"count":106,"type":22},500,[25],"The goal of this randomized, double-blind, placebo-controlled study included pregnant women at high risk of GDM at 6-15 weeks of gestation is to investigate whether supplementation with vitamin D (1600 IU per day) or prebiotics (inulin, 10 gram per day) during pregnancy has beneficial effects on controlling blood glucose during pregnancy.",[34],[111,112,34,113,114,115],"Vitamin D","Prebiotics","Blood Glucose","Gestation diabetes","Adverse pregnancy outcomes","2025-09-10",{"date":118,"type":56},"2025-09-16",{"date":120,"type":56},"2025-02-24",{"date":122,"type":22},"2026-12-31",{"name":124,"class":97},"Huazhong University of Science and Technology",2,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":16,"sex":17,"minAge":72,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":144,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":64},"100525008","strategies-for-implementing-a-postpartum-lifestyle-intervention-in-wic-clinics-100525008","NCT06116149","Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics","Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics: A Cluster Randomized Trial","STRIVE","Inclusion Criteria for Clinics:\n\n* Serve a large number of WIC postpartum participants\n* Willing and able to provide space for the study\n\nInclusion Criteria for Participants:\n\n* Age 18 or older\n* Gave birth in the past 6 weeks to 12 months\n* Obesity or history of gestational diabetes mellitus (Current BMI ≥30 kg\u002Fm², OR Medical-record documented history of gestational diabetes mellitus and BMI ≥25 kg\u002Fm²)\n* No self-reported diabetes (other than gestational diabetes)\n* Hemoglobin A1c \\\u003C6.5%\n* Not currently pregnant or planning to become pregnant in the next 6 months\n* No plans to move outside of the study region in the next 12 months\n* Access to a smartphone\n* Willing and able to participate in the intervention and provide consent\n* Not an immediate family member of the staff at the WIC clinic\n* Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator or study coordinator",{"count":135,"type":22},722,[25],"The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women.",[139,140,141,34,142,143],"Obesity","Gestational Diabetes","Lifestyle, Healthy","PreDiabetes","Hyperglycemia",[145],"Diabetes Prevention Program","2025-07-22",{"date":148,"type":56},"2025-07-25",{"date":150,"type":56},"2023-12-12",{"date":152,"type":22},"2027-04",{"name":154,"class":97},"Tulane University",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":72,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100557259","phase-2-inhaled-insulin-vs-rapid-acting-injections-for-post-meal-glucose-control-in-women-with-gestational-diabetes-100557259","NCT06535789","Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes","The Safety and Efficacy of Rapid Acting Inhaled Technosphere Insulin (Afrezza) Compared With Subcutaneous Insulin to Achieve Pregnancy-Specific Postprandial Targets Among Patients With Gestational Diabetes","INHALE-GDM","Inclusion Criteria\n\n1. Ability to provide informed consent for study participation\n2. Age ≥18 years and \\\u003C41 years old\n3. Singleton pregnancy at 24-34 weeks gestation\n4. Diagnosis of GDM via standard 1-step or 2-step criteria\n5. Treated with an insulin regimen that includes a RAA bolus of any type for breakfast, with a dose \\\u003C20 units\n6. Pre-pregnancy or first trimester body mass index (BMI) 25-45\n7. Investigator believes that the protocol can be safely conducted by the participant\n8. Able to read and speak English\n\nExclusion Criteria\n\n1. Type 1 diabetes or type 2 diabetes\n2. HbA1c ≥ 6.5%, FBG ≥125 mg\u002Fdl or 2-hr glucose ≥200 mg\u002FdL on 75g OGTT, or random plasma glucose ≥200 mg\u002FdL (consistent with pre-existing diabetes and not GDM diagnosis)\n3. Current use of any non-insulin glucose lowering medication\n4. Using TI (Afrezza), regular insulin, or ≥20 RAA units at breakfast (NPH is permissible)\n5. Peak expiratory flow \\\u003C80% predicted as measured by peak flow meter\n6. Recent history of asthma (defined as using any medications to treat asthma within the last year), chronic obstructive pulmonary disease (COPD), or any other clinically important pulmonary disease (e.g., cystic fibrosis or bronchopulmonary dysplasia), or significant congenital or acquired cardiopulmonary disease as judged by the Investigator\n7. Smoking (includes cigarettes, cigars, pipes, and\u002For vaping devices) within 90 days prior to screening\n8. History or current diagnosis of lung cancer\n9. Current or anticipated use of oral, inhaled or injectable glucocorticoids during the time period of the trial (topical glucocorticoid use is acceptable)\n10. Renal or hepatic impairment that in the investigator's judgment poses a safety risk for the study participant\n11. Recurrent Level 2 (blood glucose \\\u003C54 mg\u002FdL) or Level 3 severe hypoglycemia events\n12. Current use of non-cardio-selective beta blockers\n13. Being a member of the study team, having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study Investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial","40 Years",{"count":165,"type":22},30,[167,168],"PHASE2","PHASE3","Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.",[29,171,172,34],"Pregnancy Complications","Glucose Metabolism Disorders",[140,174],"Inhaled Insulin","2025-05-13",{"date":177,"type":56},"2025-05-15",{"date":179,"type":22},"2025-05",{"date":181,"type":22},"2025-07",{"name":183,"class":97},"Jaeb Center for Health Research",5,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":192,"targetDuration":4,"studyType":23,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":64},"100570191","early-screening-for-gestational-diabetes-mellitus-in-a-low-risk-population-100570191","NCT06704035","Early Screening for Gestational Diabetes Mellitus in a Low Risk Population","EaGeR","Inclusion Criteria:\n\n1. Pregnant women aged 21-39 years at recruitment\n2. Singleton pregnancy\n3. Less than 16 weeks pregnant at recruitment\n4. Intend to receive antenatal care and give birth at the National University Hospital\n\nExclusion Criteria:\n\n1. Known pre-existing type 1 or type 2 diabetes mellitus at recruitment\n2. Classified as high-risk for GDM at pregnancy booking using the traditional checklist:\n\n   2.1) Age ≥40 years 2.2) Overweight\u002Fobese, i.e., body mass index (BMI) ≥25.0 kg\u002Fm2 2.3) First degree relative with diabetes mellitus 2.4) Previously delivered a baby ≥4 kg 2.5) Previously diagnosed with GDM 2.6) Impaired glucose tolerance (IGT) or impaired fasting glycaemia (IFG) on previous testing 2.7) Polycystic ovarian syndrome (PCOS) 2.8) Poor obstetric history (e.g. recurrent pregnancy loss, previous intrauterine death, congenital malformations) 2.9) History of chronic hypertension, hyperlipidaemia or cardiovascular disease 2.10) Glycosuria ≥ 2+ on urine dipstick\n3. Taking systemic steroid medication or metformin\n4. Participation in another intervention trial",{"count":193,"type":22},120,[25],"This new feasibility pilot study aims to refine the design and protocols for a larger trial that will investigate the potential benefits of early oral glucose tolerance test (OGTT) screening in a population traditionally defined as low-risk for development of gestational diabetes. The study will evaluate its potential effectiveness in reducing the risks of neonatal morbidity\u002Fmortality and obstetric complications. Additionally, a machine learning algorithm to predict gestational diabetes mellitus (GDM) risk based on routinely obtained clinical information at pregnancy booking, and minimally invasive methods, such as continuous glucose monitoring (CGM) and gingival crevicular fluid (GCF) sampling, are being explored to predict the risk of hyperglycaemia. This study aims to investigate the utility of early pregnancy screening to enable timely detection and management of early gestational diabetes development in a low-risk population, ultimately promoting better health outcomes for mothers and their babies.",[197,34],"Gestational Diabetes Mellitus (GDM)",[199,200,201,202,203,204,205,206,207,208],"Early screening","Gestational diabetes","Oral glucose tolerance test (OGTT)","Neonatal complications","Pregnancy complications","Machine learning algorithm","Continuous glucose monitoring (CGM)","Gingival crevicular fluid (GCF)","IADPSG criteria","WHO 2013 gestational diabetes criteria","2024-11-21",{"date":211,"type":56},"2024-11-25",{"date":213,"type":22},"2024-12-01",{"date":215,"type":22},"2026-11-30",{"name":217,"class":97},"National University Hospital, Singapore",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":16,"sex":17,"minAge":72,"maxAge":73,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":235,"locationsCount":64},"100407421","comparison-of-the-detection-rates-of-50-gr-100-gr-ogtt-and-75-gr-ogtt-that-require-medical-treatment-of-gdm-100407421","NCT04585204","Comparison of the Detection Rates of 50 Gr-100 Gr OGTT and 75 Gr OGTT That Require Medical Treatment of GDM","Inclusion Criteria:\n\n* Pregnant women\n\nExclusion Criteria:\n\n* Already diagnosed by diabetes mellitus\n* Multiple pregnancy",{"count":225,"type":22},2282,[25],"Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.",[140,34],"2024-08-14",{"date":231,"type":56},"2024-08-15",{"date":233,"type":56},"2020-10-01",{"date":213,"type":22},{"name":236,"class":97},"Ankara City Hospital Bilkent"]