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Gestational Diabetes clinical trials

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NCT ID: NCT05946785 Recruiting - Clinical trials for Gestational Diabetes

Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

Start date: July 1, 2023
Phase: Early Phase 1
Study type: Interventional

The purpose of this investigation is to examine the role of oxidative stress in aberrant microvascular function in otherwise healthy women with a history of GDM.

NCT ID: NCT05932251 Recruiting - Clinical trials for Gestational Diabetes

Towards Precision Medicine for Diabetes in Pregnancy

ToPMedDiP
Start date: June 19, 2023
Phase:
Study type: Observational

Rationale: Gestational diabetes is currently treated by the one-size-fits-all-approach. Treatment efficacy is poorly defined and inconsiderate of patients clinical presentation Objective: To characterize the efficacy of pharmacological treatment of gestational diabetes mellitus between patients with distinct metabolic phenotypes Study design: Prospective observational study, in metformin-treatment efficacy is compared between patients with GDM caused by insulin resistance and patients with GDM caused by low insulin secretion. Study population: A prospective cohort of 103 women with diagnosed gestational diabetes mellitus treated by metformin. Main study parameters/endpoints: Primary outcomes is the glucose-disposition-index in late pregnancy (35-37 weeks gestation) and requirement for supplemental insulin-treatment. Secondary outcomes include insulin sensitivity (Matsuda-index), insulin secretion (Stumvoll-index), HbA1c, gestational weight gain, body composition, physical activity, eating behavior, plasma biomarkers, glucose control, and maternal and infant pregnancy outcomes.

NCT ID: NCT05925010 Recruiting - Clinical trials for Gestational Diabetes

Does Soluble Fiber Supplementation Result in Lower Postprandial Blood Glucose in Women With Gestational Diabetes Compared With no Supplementation After a Standardized Breakfast?

DiFiGDM
Start date: January 2, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to investigate the effect of supplementation of 10g soluble fiber from guar on postprandial blood glucose levels in women with gestational diabetes after consumption of a standardized meal compared with no supplementation. Null Hypothesis H0: Soluble fiber supplementation will not result in a lower postprandial blood glucose increase in women with gestational diabetes compared to no supplementation after consumption of a standardized meal. Alternative hypothesis H1: Soluble fiber supplementation will result in a lower postprandial blood glucose increase in women with gestational diabetes compared to no supplementation after consumption of a standardized meal. Study participants are randomly assigned to the intervention (consumption of a standardized meal and 10g soluble fibre) or control group (consumption of a standardized meal without soluble fibre). After a 2-day wash-out phase, the two groups are switched (the intervention group becomes the control group and vice versa) with the same standardized procedure.

NCT ID: NCT05924724 Recruiting - Clinical trials for Gestational Diabetes

Treatment Satisfaction and Treatment Adherence of Diabetic Women Through the Use of FGM

Flash
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The incidence of gestational diabetes mellitus (GDM), a glucose tolerance disorder during pregnancy, is increasing. In Germany, it reached 8.58 % in 2019. Standardized treatment has reduced complications for mother and child. Blood self-measurement is currently used to monitor glucose levels, but it is burdensome and disliked by patients. Flash Glucose Monitoring (FGM) was approved in 2017, but its routine use lacks sufficient data. This pilot project aims to study the impact of FGM on patient satisfaction and adherence to therapy. The hypothesis is that FGM will improve patient experience and increase therapy adherence. The study will include 100 GDM-diagnosed women who will be randomly assigned to FGM or SMBG treatment. The primary endpoint is treatment satisfaction and adherence, measured through step count, physical activity, food error count, and weight gain. The project aims to provide data for patient-centered decision-making on glucose monitoring systems, following the principles of the Association of Diabetes Counseling and Training Professions in Germany (VDBD).

NCT ID: NCT05917808 Recruiting - Pregnancy Related Clinical Trials

Food Product for Management of Gestational Diabetes

Start date: May 29, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot open pre-post clinical trial is to test effects of a wholegrain product in patients with newly diagnosed gestational diabetes. The main question it aims to answer is: Does the wholegrain product improve glucose tolerance and insulin sensitivity during a 75 g oral glucose tolerance test (OGTT). Participants will consume product on two consecutive evenings shortly after the first OGTT and will then perform a second OGTT. Researchers will compare the results of the first and second OGTT to see if glucose tolerance improved after consumption of the test product.

NCT ID: NCT05909046 Recruiting - Clinical trials for Gestational Diabetes

A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP)

Start date: July 24, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05852639 Recruiting - Clinical trials for Gestational Diabetes

Fetal CPR at Term for Prediction of Adverse Neonatal Outcome in Pregnancies Complicated by GDM

Start date: November 30, 2022
Phase:
Study type: Observational

The goal of this observational study is to evaluate fetal cerebroplacental ratio at term and its relation to adverse neonatal outcome in patients with gestational diabetes. The main question[s] it aims to answer are: - To evaluate the efficacy (sensitivity & specificity) of fetal cerebroplacental ratio at term in prediction of adverse neonatal outcome in pregnancies complicated by gestational diabetes - To evaluate the difference in fetal cerebroplacental ratio in patients treated by insulin & those on metformin - to evaluate the incidence of adverse neonatal outcome in patients treated by insulin & those on metformin. Participants will undergo ultrasound and doppler study at 37 weeks & every two weeks thereafter till delivery. Neonatal assessment will be done after delivery to exclude adverse outcomes.

NCT ID: NCT05773677 Recruiting - Clinical trials for Gestational Diabetes

Diet in Twin Pregnancy: the Wellness of Mother and Babies.

FIT
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate how variations in maternal nutrition may affect twin pregnancy and in particular: - incidence of maternal obstetric complications: - gestational diabetes - gestational hypertension or preeclampsia - intrahepatic cholestasis (ICP) - fetal growth, development and birth weight of the babies

NCT ID: NCT05752955 Recruiting - Hypertension Clinical Trials

SMART Health Pregnancy 2 - Intervention to Reduce Anaemia and Cardiometabolic Risk During Pregnancy and in the First Year Following Birth

Start date: June 6, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to determine if a complex intervention called SMARThealth Pregnancy can improve the detection and management of high-risk conditions during pregnancy and in the first year after birth in women living in rural India. The main questions it aims to answer are: - Can screening of pregnant and postpartum women using the SMARThealth Pregnancy intervention decrease anaemia prevalence at 1 year after birth? - Can the SMARThealth Pregnancy intervention improve postnatal testing after a pregnancy affected by hypertension and diabetes? Participants in the intervention group will be screened by their community health worker at several timepoints during pregnancy, and in the first year after birth using the SMARThealth Pregnancy tablet App. The community health worker will ask about each woman about her medical and obstetric history, then measure her blood pressure, haemoglobin (using a point of care device), and offer a referral for a glucose tolerance test when indicated. Women who screen positive for anaemia, hypertension or diabetes will be given advice and referred to the primary care doctor. The primary care doctor will have a complimentary tablet app to facilitate electronic referral and evidence-based prescribing when indicated. The comparison group will have usual antenatal and postnatal care.

NCT ID: NCT05648721 Recruiting - Clinical trials for Gestational Diabetes

The Effects of a Digital Application for GDM Management in Improving Patients' Compliance

Start date: May 18, 2023
Phase: N/A
Study type: Interventional

Gestational diabetes mellitus (GDM) is the most prevalent complication in pregnancy. Patients' follow-up and treatment is performed in specialized GDM clinics that teach and support women in implementing lifestyle changes, blood glucose self-monitoring, and nutritional and pharmacologic therapy. Recently, mobile health (mHealth) applications have been introduced as a resource to improve self-management and follow-up among pregnant women. The proposed study will examine the efficacy of the GDM management mHealth application in improving patients' compliance and satisfaction, glycemic control, and pregnancy outcomes. A multicenter randomized controlled trial of women with GDM treated in the GDM clinics. Women will be randomly allocated to a research group that will use the GDM application and a control group that will receive regular follow-up without the GDM application. The primary outcome is patient compliance, defined as the actual blood glucose measurements/instructed measurements ×100. Secondary outcomes include glycemic control parameters, and maternal and neonatal complications.