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23 active trials for Gestational Diabetes Mellitus

A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus

Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.

Start: July 2021

Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial

The goal of this prospective study is to determine whether there is superiority of 10 Twizzlers to the 50 gram glucola beverage for screening for GDM in a population based study.

Start: April 2015

Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers

Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and Gynecologists (ACOG) to recommend a delayed cord clamping at least 30-60 seconds in vigorous term and preterm infants at birth. Although DCC has been found to be beneficial to infants, the additional blood provided by DCC could increase the incidence of jaundice that requires phototherapy and the hyperbilirubinemia, and the time prolonged by DCC might jeopardize timely resuscitation efforts, if needed. The acid-base status in umbilical cord blood at birth reflects the newborn's aerobic and anaerobic intrauterine metabolisms and is an objective measure of the fetal exposure and response to hypoxia during labour. Gestational diabetes mellitus (GDM) is a condition in which glucose intolerance develops during pregnancy. It has been estimated in 2009 that nearly 7% of pregnancies are complicated by diabetes and approximately 86% of these cases represented women with GDM. The Hyperglycemia and Adverse Pregnancy Outcome study (HAPO) revealed that the infants of diabetic mothers (IDMs) are at increased risk of neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia, and birth trauma. And newborns to diabetic mothers are at increased risk of neonatal respiratory distress syndrome (RDS) and hypoxia, a major cause of admission in neonatal intensive care units. There is little direct evidence on the implementation of delayed umbilical cord clamping in the risk group of IDMs. Therefore, it no clear that the effectiveness and impairment of DCC in IDMs. Therefore, the investigators conducted a prospective study in performing DCC in the infants of diabetic mothers versus the newborns with early cord clamping (ECC) to assess the effect of DCC on neonatal bilirubin levels, hyperbilirubinemia incidence, acid-base status and hypoxia in IDMs.

Start: September 2019

The Effect of Oral Probiotics on Glycemic Control of Women With Gestational Diabetes Mellitus

Scientific background: Uncontrolled gestational diabetes mellitus (GDM) is associated with severe maternal and neonatal morbidities. Treatment of GDM is multidisciplinary and includes lifestyle changes and medications. However, the efficacy of these treatments is limited due to poor motivation, daily painful blood tests and multiple injections. Probiotic supplements were shown to modulate the gut microbiome by reducing the adverse metabolic effects associated with pathogenic microbial colonization. Promising effects on glycemic control and insulin resistance in non-pregnant diabetic patients were reported. However, the effect of probiotics on glycemic control in GDM has not been elucidated. Objectives: To examine the effect of a mixture of probiotic strains given daily on maternal glycemic parameters, and pregnancy outcomes among women with GDM. Working hypothesis: Oral administration of probiotics will be effective in glucose control of patients with GDM and their neonates without causing significant adverse effects. Type of research and methods of data collection: A prospective randomized, double blind, placebo controlled trial. Women newly diagnosed with GDM will be recruited and followed in the GDM clinic and Maternal-Fetal Medicine ward (including the research clinic) at Emek Medical Center. They will be divided into a research group, receiving the probiotic formula Femina II and a control group, receiving a placebo (2 capsules/day) until delivery. Glycemic control will be evaluated by daily glucose charts. After 2 weeks of diet and probiotic/placebo treatment and thereafter, pharmacotherapy will be started in case of poor glycemic control according to the daily glucose charts. Blood tests for glycated molecules will be performed. Fetal well-being and growth will be assessed. The primary outcomes are: The rate of women requiring medications for glycemic control Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products.

Start: January 2020

User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study

Refine content and delivery of the mHealth delivered lifestyle intervention program through iterative testing with small groups of users who provide feedback through on-line asynchronous focus groups.

Start: September 2015

GDM and Its Consequences in Mothers and Offsprings

Gestational diabetes mellitus (GDM) is one of the most common disorders which occured during pregnancy. GDM is not only associated with short-term maternal and fetal adverse outcomes, but also related to a wide range of long-term consequences for both mother and child. The GDM and Its Consequences for mothers and offsprings (GDMCMO) aims to establish a cohort to follow both maternal and offsprings'short-term and long-term outcomes, including fetal malformations including congenital heart diseases, birth weight, preterm birth, caesarean section delivery, body growth and neurodevelopment after birth, obesity, type 2 diabetes and impaired insulin sensitivity and secretion, lung health and allergic diseases later in life for offspring, as well as future type 2 diabetes and cardiovascular risk factors for mother after delivery. Biological samples including blood and tissue samples of mothers and children are also collected during pregnancy and after delivery.

Start: February 2012

Effects of Gestational Diabetes Mellitus on Children

Abstract Gestational diabetes mellitus (GDM) refers to different degrees of glucose intolerance or impaired glucose tolerance,which are commonly found on non-diabetic persons during pregnancy.GDM is an important public health issue that has a huge impact on children's health.According to statistics,the global occurrence of GDM in 2017 was as high as 16.2%.As well as lifestyle changes that are leading to an increased number of women with overweightness and obesity,the increasing number of"older mothers"responding to the second-child policy are raising up the percentile of GDM by the year.infancy and pre-school age are the important stages of physical growth and psychomotor development.At present,there are few domestic and International studies on the impact of GDM on the health of children,and the conclusions are not the same.There is a lack of long-term follow-up and Chinese samples. This study focuses on the current new hotspot in the research of the children's health problems, based on the 1000-day life concept and theory of DOHaD. Prospective cohort study methods and real-world studies were used. To study and clarify the effect of GDM on the neuropsychological development and physical growth indicators of children in China, and further explore the possible mechanism of action and the related indicators of predictive value, looking for possible early intervention targets. The results are expected to expand the data sources of this type of research in China, improve the data quality and clarify the characteristics of this type of population in China, and provide data support for the revision of maternal and child health related policies.

Start: June 2019

Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids

This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.

Start: November 2019

Nutrition and Pregnancy Intervention Study

A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery. The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated. Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.

Start: October 2013

The Next Generation Longitudinal Birth Cohort Diabetes Study

The overall aim of this project is to understand the independent roles of maternal factors, intrauterine exposures, genetic factors, and postnatal environment on the development of obesity and youth-onset type 2 diabetes (T2D) in childhood.

Start: September 2013

Pre-pregnancy Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes in Overweight and Obese Women

The overall purpose of this study is to determine the efficacy of a pre-pregnancy lifestyle intervention to reduce the recurrence of gestational diabetes mellitus in multiethnic women with overweight or obesity.

Start: August 2016

Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study

This observational study is designed to determine how sugars, lipids and proteins in breast milk vary among mothers; is affected by maternal diet, health and microbiota and vary over the course of lactation. Additionally, the study is designed to determine how the structure and composition of complex milk sugars, maternal health status and diet influence the development and maintenance of infant gut microflora.

Start: April 2009

Myo-inositol for Reduction of Insulin Therapy in Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is defined as hyperglycemia first-diagnosed during pregnancy. Glycemic control reduces GDM-related complications. With the new diagnostic criteria of GDM, up to 25% of pregnant women have GDM, whereas it was previously 6-10% in France. Therefore caring for women with GDM is very time-consuming. Therapeutic strategy includes dietary and lifestyle measures and additional insulin therapy for 15 to 40% of the women with GDM if the glycemic targets are not achieved after a period of 1 to 2 weeks of diet. Insulin therapy is imperfect for the following main reasons: need for education (i.e. subcutaneous administration, dose titration), hypoglycemia and weight gain, limited acceptance and high cost. Psychosocial deprivation is associated with more cases of GDM and health accessibility may be unequal. MYO-INOSITOL (MI) is an oral dietary supplement, which reduces insulin resistance. Women with GDM are deficient in MI. MI supplementation safely prevents GDM by 65 to 87% in high-risk women. A pilot study has shown a 75% reduction of the need for insulin during GDM not controlled by diet. The coordinator investigator propose here, for the first time, a randomized controlled study evaluating MI versus placebo in women with newly diagnosed GDM.

Start: March 2020

The Impact of Activity Promoting Video Games on Glycemic Control in Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) affects up to 3-5% of all pregnancies. When diagnosed with GDM, women undergo nutritional counseling, blood sugars monitoring and are encouraged to exercise regularly. Women who do not meet therapeutic targets may need to add insulin injections. Activity promoting video games are an attractive possibility for improvement of exercise compliance. The objective of this study is to determine whether providing women recently diagnosed with GDM with a Nintendo Wii™ activity promoting gaming platform will increase activity levels, improve glycemic control of sugar levels and decrease the need for supplementary insulin treatment.

Start: July 2010

Early Screening of Gestational Diabetes Mellitus and Prospective Cohort Study of Postpartum Follow-up

Extraction of whole blood from 10 to 15ml at 24 weeks before pregnancy test, with a view to early detection of GDM, provides evidence for early intervention to improve maternal pregnancy outcomes and metabolic abnormalities.

Start: June 2019

Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring

MySweetHeart Trial is a randomized controlled trial to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with GDM and their offspring. Primary objective of MySweetHeart Trial: To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention in women with GDM to improve 1) their metabolic health (decrease in maternal weight between study inclusion after GDM diagnosis and at 1 yr postpartum) and 2) their mental health (decrease in maternal symptoms of depression during the same time period). Secondary objective of MySweetHeart Trial: To test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve other cardio-metabolic and mental health markers in women with GDM and their offspring. MySweetHeart trial is linked to MySweetHeart Cohort, an observational cohort study that assesses the effect of GDM on offspring cardiovascular health early in life. The principal investigators of the cohort are Nicole Sekarski and Arnaud Chiolero (University Hospital Lausanne, Switzerland). Their primary objective is to assess the effect of GDM on the surrogate markers of cardiovascular disease (CVD) at birth (left ventricular mass index and subclinical atherosclerosis) and the secondary objective is to assess the effect of GDM on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors.

Start: September 2016

The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus

Gestational Diabetes Mellitus (GDM) incidence is increasing worldwide, and within Canada, the Atlantic provinces statistically have been found to have highest prevalence of diabetes. Increasing evidence supports the benefit of following a low glycaemic index (GI) diet in GDM and the Canadian Diabetes Guidelines recommends replacing high GI foods for low GI foods. Despite recommendation to adapt a low GI diet in GDM, there are limitations and barriers recognized to GI utility largely focused on knowledge translation. There is sufficient research to support a low GI diet in benefiting outcomes of GDM, therefore the GI in GDM Online trial will investigate the feasibility and effectiveness of a distance low GI education intervention, adapted from Diabetes Canada's GI materials, on producing a difference in average dietary GI between a group with the intervention and standard care.

Start: October 2019

Genetic and Epigenetic Mechanisms of Developing Gestational Diabetes Mellitus and Its Effects on the Fetus

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 trialr, open-label.

Start: August 2015

Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus

Background: Gestational diabetes mellitus (GDM), GDM is the first time of gestational impaired glucose tolerance in pregnant women. It is the most common complication disease in women of childbearing age. It is associated with the high risk of adverse health outcomes for both mothers and offsprings and the variety of metabolic disease, including type 2 diabetes, etc. As for the epidemiology data of GDM in China, the prevalence is around 18% based on the criteria from the International Association of Diabetes in Pregnancy Study Groups, IADPSG. Several studies claimed that the diabetes-specific formula improved glycemic control in type 2 diabetes patients. However, the effects of medical nutrition therapy combined with the diabetes-specific formula in pregnant women with gestational diabetes mellitus (GDM) are unclear. Objective: This study examines whether medical nutrition therapy combined with Enteral Nutrition Suspension (TFP-DM, Diason 0.75 kcal/ml) in GDM women could improve the glycemic control and the pregnancy outcomes.

Start: May 2019

Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy

Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Since 2012, journals such as Nature and Science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. The current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great significance and value to improve the quality of the birth population in China and to alleviate the medical economic burden caused by obesity and metabolic diseases.

Start: December 2019