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Showing 1-20 of 261 trials
NCT06310356
There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 14 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.
NCT03023293
This study aims to investigate the associations of maternal nutritional status during pregnancy and postpartum periods with postpartum abnormal glucose metabolism in Guangzhou pregnant women. Additionally, it seeks to explore the relationships between maternal nutritional status (pre- and postnatal) and offspring health outcomes, including physical growth, neurodevelopment, and common childhood diseases.
NCT06925815
The goal of this observational cohort study is to gain deep insights into how metabolic disorders such as obesity or diabetes during pregnancy affect the metabolic and cardiovascular health of mother and child in the short and long term. It will investigate the following questions: * How do maternal metabolic disorders affect pregnancy outcomes? * How do maternal metabolic disorders affect fetal growth? * How do maternal metabolic disorders affect the newborn's metabolism and body composition? * How do maternal metabolic disorders during pregnancy affect breast milk composition? * How do maternal metabolic disorders during pregnancy affect the metabolic health of the mother after birth? Participants in this study are pregnant women who will be asked to come to the clinics for three visits during their pregnancy, as well as for the delivery of their baby, and one time 2-3 months thereafter. At each visit, researchers will perform physical examinations (such as body composition measurements) and collect biological samples (blood, urine, saliva), clinical information, and lifestyle data. At birth, researchers will collect cord blood and breast milk as well as clinical data of the delivery and the health of the baby. Researchers will measure body fat in newborn babies and at 2-3 months of age.
NCT06141941
This study will examine whether continuous glucose monitoring in patients hospitalized in the immediate postpartum period is more effective than traditional point of care glucose testing in identifying patients with hypoglycemia.
NCT04585581
The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.
NCT07517406
Gestational diabetes mellitus (GDM) is associated with significant maternal and fetal complications. The standard diagnostic test for GDM is the 75-gram oral glucose tolerance test (OGTT). However, pregnant women who have undergone bariatric surgery may not tolerate OGTT due to dumping syndrome and gastrointestinal side effects. This creates diagnostic challenges in this specific population. The aim of this prospective observational study is to evaluate whether routinely measured glycemic markers, including fasting blood glucose, postprandial blood glucose, HbA1c, and urinary glucose levels, can predict the development of gestational diabetes mellitus and related pregnancy complications in women with prior bariatric surgery. Pregnant women aged 18-50 years with a history of bariatric surgery will be enrolled and followed throughout pregnancy. The predictive value of glycemic markers for GDM, macrosomia, and polyhydramnios will be analyzed using multivariable logistic regression models. This study aims to provide alternative diagnostic approaches for GDM screening in pregnant women who are unable to tolerate OGTT and to contribute to improving maternal and perinatal outcomes in this growing patient population.
NCT05632055
The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups. Participants will be retrieved blood sample during first trimester and undergone 100 gm OGTT (oral glucose challenge test) during 24-28 weeks of gestation.
NCT07462793
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.
NCT06988306
The study is examining the health effects of gestational diabetes mellitus (GDM) intervention and medically tailored meals within home visiting. A large study is proposed that will include nearly a thousand pregnant or recently pregnant adults with recent GDM and who are from different regions and backgrounds. Two treatment approaches are compared, and both are in home visiting. One treatment group is receiving enhanced lifestyle support for GDM along with meals, and the other is receiving just the enhanced lifestyle support. The study will examine whether these interventions help reduce diabetes and pre-diabetes through 12 months postpartum, as well as other health factors like weight and blood pressure.
NCT05835596
The goal of this randomized clinical trial study is to test the potential benefits of eHealth-assisted follow-up after pregnancy complications that confer and increased risk for premature cardiovascular (CV) disease. The overarching aim is to improve short- and long-term CV health in women following pregnancy complications associated with increased risk of CV disease (hypertensive disorders of pregnancy and gestational diabetes). The investigators will develop and test a novel, personalized and user co-designed digital eHealth companion ("app") and test the app in a clinical randomized control trial. The group randomized to app use will get access to the app prior to delivery or within the first weeks postpartum, whereas the control group will not get access to the app, but receive ordinary follow-up. Both groups are invited to a comprehensive cardiovascular follow-up 14-18 months post delivery. The primary objective is to assess whether the rate of 1-year postpartum follow-up at the general practitioner's is increased with MumCare app access. Secondary objectives are to assess: 1. expectations of (and satisfaction with) postpartum eHealth-assisted technologies, 2. if health perception, sense of empowerment (self-management evaluation and general self-efficacy), modifiable risk factors for CV disease (including hypertension, dyslipidemia, blood sugar control, smoking, weight, physical activity), CV findings (including non-invasive hemodynamics) and biomarkers are affected by MumCare app use.
NCT06548828
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/or 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.
NCT07034261
The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 4-12 week postpartum oral glucose tolerance test (OGTT).
NCT07369284
The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM). The main question it aims to answer is: Does melatonin supplementation help with glycemic control, especially in lowering fasting plasma glucose level? Researchers will compare melatonin to a placebo (a look-alike substance that contains no melatonin) to see if melatonin works to improve glycemic control. Participants will: 1. Take melatonin or a placebo every day after randomization until delivery 2. Visit the antenatal clinic once every 1 to 2 weeks for follow-ups
NCT03301792
The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.
NCT06184373
One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.
NCT06648174
This study aims to examine the effects of a lifestyle intervention based on a health belief model (HBM) supported by mobile health (mHealth) and the impact of continuous glucose monitoring (CGM) on maternal glycemic parameters, cardiometabolic risk, health behavior and infant's outcomes among women diagnosed with gestational diabetes mellitus (GDM).
NCT07347262
The aim of our study is to evaluate the feasibility, and diagnostic value of oral 13C labelled glucose breath test compared to the GCT and OGTT tests.
NCT06127823
The treatment of gestational diabetes (GDM) primarily revolves around consuming an optimal diet that does not cause blood glucose levels to become excessively high and provides an adequate supply of micro- and macronutrients without resulting in excessive weight gain during pregnancy. In some cases, it may become necessary to supplement with insulin during pregnancy. However, insulin treatment is associated with personal, health-related, and healthcare cost-related implications. The rationale for this study is the lack of knowledge regarding whether the extent of support and guidance from a dietitian during pregnancy has an impact on the treatment outcomes for both the mother and the child in cases of GDM. The overall objective is to investigate differences in clinical, cost-related, and patient-reported outcomes between women with GDM randomised to either intensive dietary therapy or standard dietary care (control). The primary endpoint is the effect of intensive dietary therapy on the likelihood of remaining treated with diet only vs. needing insulin therapy. The study design is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM.
NCT06948825
The goal of this clinical trial is to evaluate the effectiveness of a 6-month lifestyle intervention compared to Metformin in postpartum women who have delivered a singleton, live born infant within the last 12 weeks to 1 year and had a pregnancy complicated by gestational diabetes. The main question this study aims to answer is: Is a Lifestyle Intervention or Metformin more effective for weight loss in postpartum women with recent gestational diabetes? Researchers will compare a 6-month Lifestyle Intervention and Metformin to see if either intervention is more effective in achieving weight loss and improving health outcomes. Participants will: * Attend an in-person baseline visit to receive a Bluetooth-enabled scale and Fitbit, have blood drawn for testing, and have their height, weight, and blood pressure measured. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length. * Track diet, physical activity, and weight using the Fitbit and Looseit! apps. * Attend weekly online group sessions for the first 4 weeks, then biweekly sessions. * If not meeting weight loss goals, be randomized to either Enhanced Lifestyle Intervention or Metformin arms of the study. * If randomized to Metformin, participants will attend one in-person meeting with the study provider, get blood drawn for testing, and undergo a urine pregnancy test before starting the medication. * Continue with biweekly group sessions or have regular check-in calls. * If randomized to the Enhanced Lifestyle Intervention, participants will get a free Instacart membership, a 1:1 session with the study health counselor focused on meal planning and free grocery delivery once a week for the remainder of the study. * Participants will meet every other week via Zoom with the health counselor and other participants in the enhanced lifestyle arm. * At the end of the 6 months, all participants will come for an in-person visit to get blood drawn for testing. Participants will also be asked to bring in their infant, and the study team will measure the infant's weight and length.
NCT07336914
This study involved two management protocols to manage diabetes in pregnancy. Sixty patients having GDM will be recruited on the basis of the OGTT and randomly allocated to two management groups. One group of patients will receive counselling and the conventional method of management. while the other group will receive a tailored diet plan and physical activity with low caloric and moderate intense exercises. Both groups will receive a dietary plan based on their sugar levels weekly basis and physical activity with pharmacotherapy to adjust their sugar levels, while the intensive group will have rigorous monitoring on a monthly basis and frequent visits with repeated lab checks. This will help us to reduce short and long-term complications with improved maternal and neonatal outcomes.