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82 active trials for Gestational Diabetes

Metabolic Syndrome and Non-alcoholic Fatty Liver During Pregnancy

The aim of this study is to evaluate the prevalence of metabolic syndrome, liver function abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk of pregnancy complications.

Start: November 2014

Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.

Start: February 2020

Choline Supplementation on Fetal Growth in Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM), characterized by maternal high blood sugar, affects up to 15% of pregnancies worldwide. GDM doubles the risk of fetal growth (i.e. macrosomia, large fetus,) which further predisposes the affected fetus to elevated risks of obesity, diabetes and cardiovascular disease later in life. The placenta mediates macrosomia by increasing fat and glucose transport to the fetus during GDM. Effective methods to normalize placental nutrient transport and prevent macrosomia are lacking. Choline is a semi-essential nutrient found in egg yolks, meat, fish and cruciferous vegetables. The demand for this nutrient increases substantially during pregnancy. Previous research demonstrated that maternal choline supplementation (MCS) normalized placental fat and glucose transport as well as fetal growth and fat mass in GDM mice. In this study, the investigators will recruit pregnant women with GDM and randomized them to receive a choline supplement (470mg/day, a dose with demonstrated safety), or a placebo for 8 weeks, starting after gestational week 28. The investigators will determine the effects of choline on fetal growth as well as the influence of choline on placental transport and epigenetic modifications in growth-related genes in the placenta and umbilical cord. Successful completion of this study will provide valuable insights into the use of choline supplement as a modifier of placental macronutrient homeostasis in GDM to improve fetal growth outcomes.

Start: April 2020

Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes

Breastfeeding has been associated with decreased obesity. However, this relationship is not as clear in children who have been exposed to GDM and the mechanisms involved are little known. The overall objective of the project is to study the mechanisms of breastfeeding on the growth of children in women who have had a GDM. More specifically, the project want to compare the macronutrient and hormone composition of breast milk of women with and without GDM. Investigators also want to associate the levels of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without DG and the growth of the child. A total of 60 women (30 with GDM and 30 without GDM) will collect breastmilk at 2 months postpartum.

Start: April 2020

Lifestyle Intervention in Pregnant Women With PCOS

Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.

Start: October 2016

iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes

The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT

Start: November 2019

Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus

Women post-gestational diabetes mellitus (GDM) have more than 7-fold increased risk of having future type 2 diabetes mellitus (T2DM). While a healthful dietary pattern reduces the risk of diabetes in post-GDM, no data support a dietary pattern tailored to the Malaysian diet. To address this issue, the investigators propose to determine the effects of dietary patterns and plasma metabolites in predicting the risk of T2DM known as the Nutritype model. The aim of this study is to identify Nutritype signatures of T2DM risk in women post-GDM using metabolomics approach.

Start: May 2020

Environmental Factors and Embryonic Development Project

The Environmental Factors and Embryonic Development Project was set up to investigate environmental exposures and behavioral factors responsible for embryonic dysplasia and gestational complications in pregnant women.

Start: August 2019

Randomized Controlled Multi-center Study of the New Nordic Diet in Gestational Diabetes Mellitus

The study evaluates whether the New Nordic Diet, compared to routine care, will reduce complications for woman and newborn, among women developing gestational diabetes mellitus during pregnancy.

Start: January 2020

Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial

Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour. In the observational group, blood glucose level during labour will be monitored and insulin-glucose-infusion is started only if needed. The hypothesis is that there will not be a difference in rate of hypoglycemia between the two groups and that the proportion of observational group participants that need infusion is low.

Start: September 2015

Visualizing Beta Cells in Patients With a History of Gestational Diabetes

In order to evaluate the difference in beta cell mass in women with and without a history of gestational diabetes mellitus (GDM), investigators aim to compare quantitative PET imaging of the pancreas between these groups. Investigators propose to measure uptake of 68Ga-NODAGA-exendin-4 in the pancreatic beta cells of these women as a measure for beta cell mass. Furthermore, investigators aim to compare uptake of the radiolabeled tracer to beta cell function measured by laboratory parameters. These highly relevant data within this at-risk population for type 2 diabetes (T2D) will provide the investigators with more information on the role of beta cell mass in the predisposition for development of T2D leading to better knowledge on the pathophysiology of this disease. This could be of great interest for development of new treatment options.

Start: November 2016

A Randomized Placebo Controlled Trial of the Effectiveness of Metformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects

The overall objective of the EMERGE trial is to determine whether metformin + usual care, compared to placebo + usual care (introduced at the time of initial diagnosis of GDM), reduces a) the need for insulin use, or hyperglycemia (primary outcome measure); b) excessive maternal weight gain; c) maternal and neonatal morbidities and, d) cost of treatment for women with Gestational Diabetes Mellitus.

Start: June 2017

The Best Timing of Delivery in Women With GDM Study

The investigatiors aimed to conduct a well-designed RCT to firstly focus on GDM women controlled with only diet and exercise, and provide an optimize process on their timing and mode of delivery

Start: July 2019

Effect of Fibre Supplements on Gestational Diabetes

The primary aim of this study is to evaluate the effect of a soluble fibre supplement in the development of gestational diabetes in women at high-risk. The secondary aim will to evaluate the effect of the soluble fibre supplement on glycaemic control in high-risk women who develop gestational diabetes in early pregnancy. DESIGN We plan to conduct a randomised open label controlled study to evaluate the effect of the consumption of soluble fibre, from early to mid-pregnancy, on the incidence of gestational diabetes, insulin sensitivity, insulin secretion and metabolic control in GDM diagnosed participants. POPULATION We will be studying women with diagnosis of gestational diabetes in previous pregnancies, (considered as high-risk) aged >18 years. TREATMENT Participants in the treatment arms will be 5 gr of Guar gum fibre supplement with meals three times a day (total daily 15 g). Participants in the placebo arms will be taking 5 gr of Cellulose three times a day (total daily dose 15 g). DURATION Participants will be involved for 12 weeks. In women with early gestational diabetes (diagnosed at first assessment): Primary outcome: Glycaemic control assessed the need of insulin treatment Secondary outcomes: In women requiring insulin treatment: days-to-insulin and total daily insulin dose.

Start: May 2018

Carbohydrate Restriction in Pregnant Women With Gestation Diabetes Mellitus

The purpose of this controlled, randomized intervention is to investigate whether a carbohydrate-restricted diet, having a positive effect on blood sugar and weigh maintaining in diabetes, is effective and safe for pregnant woman with GDM and safe for their offspring, when compared to the standard carbohydrate content diet.

Start: August 2019

Hepcidin and Glucose Metabolism

Gestational diabetes mellitus (GDM), defined as hyperglycemia with blood glucose values above normal but below those diagnostic of DM, and iron deficiency (ID) with or without anemia (IDA) are common during pregnancy. Both disease patterns are associated with an increased risk of complications during pregnancy and at delivery and may have a variety of negative effects on different aspects of child development. Thus, GDM and ID/IDA during pregnancy should be prevented. Whether iron supplementation with high oral doses acutely increases hepcidin during pregnancy, and whether this acute iron-induced increase in hepcidin decreases insulin sensitivity, is uncertain.

Start: July 2019

The Effectiveness of Rt-CGM to Improve Glycemic Control and Pregnancy Outcome in Patients With GDM

Real-time continuous glucose monitoring (CGM) systems provide users with information about current glucose levels and alert the patient before the upper or lower glucose threshold is reached or when glucose levels change rapidly. Hence, glycaemic excursions can be early identified and accordingly adapted by behavioural change or pharmacologic intervention. Randomized controlled studies adequately powered to evaluate the impact of long-term application of real-time CGM systems on the risk reduction of adverse obstetric outcomes are missing.

Start: September 2019

Empagliflozin and the Preservation of Beta-cell Function in Women With Recent Gestational Diabetes

Double-blind, parallel arm, randomized controlled trial, in which non-lactating women with recent GDM who are between 6 to 36 months postpartum to be randomized to either empagliflozin 10 mg daily or matching placebo. The duration of treatment will be 48-weeks. Beta-cell function will be assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2), measured on oral glucose tolerance test (OGTT) at baseline, 24-weeks, 48-weeks, and after a 4-week washout.

Start: July 2018

Shenzhen Birth Cohort Study

The Shenzhen Birth Cohort Study was set up to investigate the effect of early life environmental exposures on short- and long-term health consequences in Shenzhen, China.

Start: March 2018

Gestational Diabetes: a Cohort Study

Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its occurrence implies an increased risk of maternal and fetal complications and, therefore, its diagnosis and treatment are extremely important. Since the adoption of the new diagnostic criteria proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity, adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal binomial, since gestations with satisfactory glycemic control can also present complications related to the disease and increased risk of type 2 DM in the long term. The present study aims to investigate factors associated with the need for insulin use, the occurrence of perinatal complications, nutritional status, physical activity and weight retention one year after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women diagnosed with GDM according to the current criteria suggested by the IADPSG.

Start: September 2015