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Showing 1-20 of 112 trials
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.
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.
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.
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.
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).
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.
NCT06445946
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. This 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.
NCT05515744
This study will conduct a randomized trial among women with gestational diabetes (GDM). Study of Pregnancy And Neonatal health (SPAN), TIMing of dElivery (TIME) is a randomized trial that will recruit up to 3,450 pregnant women with uncontrolled GDM and randomize the timing of their delivery. Women with GDM who are approached for the trial and are found eligible but do not consent to participating in randomization for delivery will be asked to consent for chart review only (estimated additional n=3,000). The primary objective is to determine the best time to initiate delivery for GDM-complicated deliveries (defined as the time when risk of illness and death for the newborn is the lowest) between 37-39 weeks.
NCT06911372
Gestational Diabetes Mellitus (GDM) currently affects approximately 14% of all pregnancies worldwide. Importantly, the health-related consequences of GDM extend well beyond pregnancy, such that women with a history of GDM have a 40% increased risk of cerebrovascular diseases and a 67% increased risk of dementia, compared to women with a history of uncomplicated pregnancy. Women with a history of GDM have impaired skin microvascular function, compared with women with a history of uncomplicated pregnancy. Therefore, it's likely that GDM results in impaired brain blood vessel function, yet there is little-to-no information regarding the effects of GDM on brain blood vessel health and function after pregnancy. Therefore, the purpose of the study is to evaluate the effects of GDM on brain blood flow and brain blood vessel function in healthy women with either a history of GDM or uncomplicated pregnancy. In this study, the investigators will use two different types of ultrasound to non-invasively measure brain blood flow. Brain blood vessel function will be evaluated by examining the brain blood flow responses to increases in carbon dioxide (the increases in carbon dioxide are similar to what is experienced during a breath hold). Additionally, the investigators will compare the brain blood flow results to skin microvascular function to explore potential mechanisms behind possible impairments in brain blood vessel function. Skin microvascular function will be assessed using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) on dime sized areas of the forearm. Finally, for screening purposes and to further explore potential mechanisms behind any potential impairments in brain blood vessel function, the investigators will perform blood draws to determine the metabolic health of the participants and to analyze for substances that influence blood vessel function.
NCT06643351
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.
NCT06896799
The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus. The main questions it aims to answer are: * The difference in the magnitude of postprandial rise in blood glucose between the two test meals. * The difference in the magnitude of postprandial change in serum levels of gut hormones between the two test meals. * The difference in mean change in pre-post ingestion satiety scores between the two test meals. * The difference in 24 hour energy and macronutrient intake following the two test meals. Participants will attend two study visits at the Centre for Public Health, with an interval of at least two days between the visits and complete the following, anthropometric measurements, demographic and appetite questionnaires, glucose measurements, two food diaries and fasting blood samples and the consumption of the study breakfast. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Researchers will compare the results from participants between the two test meals to see if the order of macronutrient consumption has any effect on post-prandial glycaemia, gut hormones, satiety scores and energy and macronutrient intake.
NCT05909046
DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM. Follow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions
NCT06876090
Sarcopenia is a syndrome characterized by loss of skeletal muscle mass and strength, and physical performance deterioration. Prevalence of sarcopenia in elderly people is remarkably high (prevalence of about 25% in 60+ years people). In type 2 diabetes (T2D), sarcopenia is emerging as comorbidity of major concern. Sarcopenia, however, is not limited to elderly people, as it can develop also in younger individuals with prevalence around 9% or even higher according to some investigators. Of note, sarcopenia has been reported even in the 20-29 years interval. This interval includes women of childbearing age, thus raising the question whether sarcopenia may occur also in women with gestational diabetes (GDM) and whether this may affect pregnancy outcomes. Also, association between sarcopenia and cognitive impairment has been repeatedly reported, to the point that some authors have emphasized the importance of early sarcopenia recognition for prevention of cognitive impairment. Therefore, our main aims are: 1. To ascertain whether sarcopenia is present in GDM and, in that case, its prevalence; 2. To identify risk factors for sarcopenia; 3. To determine sarcopenia impact on pregnancy outcomes, and cognitive function. During pregnancy, all women will undergo oral glucose tolerance test (OGTT) for assessment of the glucometabolic condition. Several clinical variables of interest in sarcopenia will also be recorded. As regards the OGTT data, special focus will be on the assessment of insulin resistance, both at fasting and during the dynamic conditions determined by the OGTT. Notably, the special interest for insulin resistance is due to the reason that this type of metabolic alteration is known to be a risk factor for sarcopenia. In fact, all women will then undergo testing for diagnosis of sarcopenia (or presarcopenia), and all data and parameters will be analyzed to identify relationships between sarcopenia-related variables and GDM-related ones. It is worth noting that in consideration of the exacerbated insulin resistance condition often observed in GDM, the investigators expect indeed a not negligible prevalence of sarcopenia (or at least presarcopenia) in GDM women, despite the young (non-elderly) age. In addition, since insulin resistance is often present in pregnancy even in the absence of dysglycemia, the investigators do not exclude to identify some cases of sarcopenia/presarcopenia even in pregnant non-GDM women. This study will be the basis for future studies (also of interventional type), especially in women with GDM for prevention of sarcopenia and related possible pregnancy complication and adverse pregnancy outcomes, as well as for possibly contributing to mitigation of risk for T2D development in later life.
NCT03610178
This is a randomized controlled trial of different glycemic targets during tratment of women with GDM with assessement of epygenetic aspects of their effects on the fetus and pregnancy outcomes. This study is interventional, randomised controlled trial, open-label.
NCT06431997
This is a randomized controlled trial, aiming to investigate whether a time-restricted eating (TRE) can reduce the incidence of gestational diabetes mellitus (GDM) in high-risk pregnant women. Investigators intend to conduct a 3-month randomized controlled study to compare the effects of 10-hour TRE and habitual eating time on GDM .
NCT06243939
This study is a randomized controlled experimental study planned to investigate the effect of motivational interviewing on health management self-efficacy and quality of life in pregnant women with gestational diabetes mellitus.
NCT07189221
Gestational diabetes mellitus (GDM) affects approximately 1 in 7 pregnancies globally and is associated with significant short and long-term health consequences for both mothers and infants. While lifestyle interventions during pregnancy can effectively reduce GDM risk and its complications, there is limited guidance on how to translate this evidence into routine antenatal and postpartum care. This project looks to address this gap by exploring the effectiveness of the B2B\&Me+ programme within regular maternity services across four European countries and how best to implement it. Women identified as being at higher risk of developing GDM using a GDM screening tool will receive access to the smartphone application that connects them with their health coach, who will provide personalised support about healthy eating, physical activity, mental wellbeing, and infant care from early pregnancy until 9 months after birth. The participants will be randomised initially to a specific referral pathway for the intervention.
NCT07158970
This study evaluates the impact of incorporating home-ultrasound (home-US) devices into telemedicine care for patients with gestational diabetes mellitus (GDM). The study will compare satisfaction, clinical outcomes, and healthcare costs between standard high-risk pregnancy care and care augmented by home-US.
NCT02343354
Women with gestational diabetes (GDM) have increased risk of developing type 2 diabetes; their children show more insulin resistance and diabetes compared to offspring of mother without diabetes in pregnancy. An increased diabetes risk is also observed among partner of adult with prediabetes/type 2 diabetes. The investigators have pilot-tested a program for diabetes risk reduction among women within 5 years of a GDM pregnancy (MoMM program). The investigators are now enhancing the program to engage directly the partner (MoMMii program). In MoMMii, 66 couples with a history GDM in the mother will participate in a multimodal diabetes prevention program that includes healthy meal preparation training, discussion of eating and physical activity behaviours and developing home environments that facilitate healthy habits, pedometer-based step count monitoring, and participation in family-based activities (frisbee, soccer) as well as individual exercise (e.g., use of exercise equipment, floor resistance exercises). Participants will be encouraged to communicate between sessions with study personnel and with one another to create a between family support network. All mothers and fathers will participate in five sessions over six months. The investigators will examine changes in health-related behaviours, blood pressure, glucose levels, and insulin sensitivity/resistance in both mothers and fathers.