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Gestational Diabetes clinical trials

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NCT ID: NCT03008824 Recruiting - Clinical trials for Gestational Diabetes

Micronutrients in Pregnancy as a Risk Factor for Diabetes and Effects on Mother and Baby

PRiDE
Start date: September 2012
Phase: N/A
Study type: Observational

There is a rapidly escalating epidemic of obesity and type 2 diabetes across the world, with the fastest rise occurring in low- and middle-income countries. India not only has one of the highest rates in the world, but the disease starts at a younger age and lower levels of body weight than in UK white caucasians. Among city-dwelling Indians, approximately 8% of people aged 30-40 years already have diabetes. This is creating a heavy burden of disease and disability, and an intolerable economic burden through medical costs and lost earnings. Until now, efforts to prevent diabetes have mainly focussed on modifying the diet, lifestyle and activity of at-risk adults (for example those who are overweight, have a family history of diabetes or already have high blood sugar). However, recent research has indicated that factors acting in early life (during development in the womb) place an individual at risk of later diabetes. These include maternal malnutrition and low birthweight, and diabetes in the mother during pregnancy. Our research has shown that Indian mothers often have low vitamin B12 levels, which in turn causes high blood levels of a harmful metabolite (homocysteine). We have shown that these mothers get more diabetes in pregnancy. Their children are more likely to born with a low birth weight, and develop more body fat and higher plasma insulin levels during childhood, which are signs of higher diabetes risk in later life. The risk is increased further if the mother has normal or high status for another B vitamin, folate. Thus, we have shown, for the first time a link between a specific nutritional deficiency in the mother and diabetes risk in the next generation. One possible mechanism for the effect of maternal nutrition on risk of diabetes in her children is through epigenetic effects, whereby the nutritional environment during early development affects the switches that control gene expression. Since these switches are passed on via either parent, we think it is possible that paternal vitamin B12 status could also be important.

NCT ID: NCT02980276 Completed - Clinical trials for Gestational Diabetes

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

EMERGE
Start date: June 6, 2017
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT02963753 Completed - Clinical trials for Gestational Diabetes

Hyperemesis Gravidarum and 75 Gram Oral Glucose Tolerance Test

Start date: January 2016
Phase: N/A
Study type: Observational

Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a clinical syndrome including endocrine and metabolic complications. Recently, some investigators have been begun performing researches related to the development of gestational diabetes mellitus (GDM) in pregnant women with HEG because they think about those metabolic and endocrine complications of HEG.In the literature there are few studies assessing how HEG has effects on GDM or 75 gram oral glucose tolerance test (OGTT). So the investigators aim to evaluate the effects of HEG on 75 gram OGTT.

NCT ID: NCT02947503 Recruiting - Insulin Resistance Clinical Trials

Pregnancy Outcomes: Effects of Metformin Study (POEM Study)

POEM
Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

One approach to prevent the rising burden of diabetes is to address the issue of gestational diabetes mellitus (GDM). GDM has a growing prevalence up to 5-10% (and even higher in specific subgroups), with a pregnant population becoming older and more obese worldwide. GDM increases the risks of complications during pregnancy, at delivery and on the longer term, like type 2 diabetes (T2D) and persistent obesity, in mother and child. Moreover, insulin added to diet as the standard care for GDM has disadvantages for mother (maintenance of hyperinsulinaemia, increasing weight and blood pressure) and child (macrosomia, hypoglycaemia) with related adverse pregnancy outcomes. Metformin, as an insulin sensitizer targeting the cause of GDM, may have essential benefits, as suggested by observational studies. However, RCTs with metformin (early positioned in the treatment of GDM) are still lacking. The POEM study is the first Randomized controlled trial (RCT) in GDM to test the hypothesis that metformin, early given from the start of the diagnosis GDM, on top of diet and lifestyle improves clinically relevant pregnancy outcomes in mother and child during pregnancy, at delivery and on the longer term - up to 20 years after birth.

NCT ID: NCT02945540 Recruiting - Clinical trials for Gestational Diabetes

Assessment of Patient Satisfaction Program "Gestational Diabetes"

SATISFYDG
Start date: April 2016
Phase: N/A
Study type: Observational

This study seeks to evaluate patient satisfaction within the patient therapeutic education program "gestational diabetes" (multidisciplinary and multi-professional program) to see if they deem effective to limit the impact of gestational diabetes on pregnancy . Patients are questioned on the skills acquired in everyday life, the effective support in personal development, development of self-determination capabilities and communication with health professionals. This study must include all patients participating in the therapeutic education program for a year and meeting the inclusion criteria.

NCT ID: NCT02912091 Completed - Clinical trials for Gestational Diabetes

The Effect of Steroids for Fetal Lung Maturity on Maternal Glucose Levels

Start date: August 2012
Phase: N/A
Study type: Observational

This study will look at blood sugar levels in pregnant women who have been given a glucocorticoid (steroid) medication to enhance fetal lung maturity. The findings will help determine the likelihood, predictive value, adverse effects, response of patients diagnosed with gestational diabetes and time course of blood sugar elevation following steroids.

NCT ID: NCT02811172 Completed - Obesity Clinical Trials

Behavior of Biomarkers During Pregnancy and Lactation Through a Biological Multi-paradigm Model: BECOME Study Protocol

BECOME
Start date: January 2017
Phase:
Study type: Observational

Background Despite of advances in research, at the moment, various points related to the physiology of gestation and the etiology of severe diseases that can be developed in the course of it remain unknown. One of those aspects is the behavior of biomarkers (triglycerides, prolactin, glucose and cholesterol) during pregnancy, which experience a gradual increase in their levels until they reach the peak of hypertriglyceridemia, a few days before delivery. Several studies have reported that biomarkers experience a higher elevation in diabetic and obese pregnant women and in those women who suffer preeclampsia. The description of their behavior in different population of pregnant women (healthy women and women at risk) would identify the relation of these with some of the alterations that occurs more frequently during pregnancy. Objective The aim of this study is to develop a multi-paradigm biological model of systems to determine triglyceride, prolactin, glucose and cholesterol levels during pregnancy and its relation with lactogenesis in healthy and risk pregnant women. Methods A prospective cohort study will take place with women during pregnancy and lactation. Participating women will be divided into two groups. One group will be integrated by healthy women and the other group by pregnant women with a risk medical history. The personal, family and a detailed medical history will be collected in each group. A study of all the variables which influence the level of the mentioned biomarkers (triglycerides, cholesterol, glucose and prolactin) will be done. The universe consists in 4,300 women, who constitute the historical average deliveries during the semester in the city of Granada (Spain). The sample collection will be made in medical office's pregnancy control in Granada's hospitals, in their respective health centers and during the second half of 2015. The sample will be stratified and probabilistic. Peculiarities of pregnant women will be taken into account when calculating the size of the study sample. This sample will be made up of 224 women who comply with the inclusion criteria and that have signed the informed consent. To achieve the project objectives an organization comprising six theoretical and practical phases enabling the scientific development of the project. During the first phase, the technical and administrative preparation of the project is constructed. Thereafter, the work is divided into two action areas which encompass the collection and data modeling. The creation of a biological multi-paradigm computer simulation model of the levels of biomarkers in different months of pregnancy and in the various pathologies of pregnant women can be very effective to know the risks that involve high levels of lipids for the mother and for the baby.

NCT ID: NCT02806739 Completed - Clinical trials for Gestational Diabetes

Soy Supplementation and Gestational Diabetes

Start date: January 2013
Phase: Phase 0
Study type: Interventional

The purpose of this study is to assess the feasibility of randomizing pregnant women at high risk for gestational diabetes to a 24-week period of soy food consumption. This study will also examine the effects of soy protein and isoflavones on glucose metabolism and lipid levels among pregnant women at high risk for gestational diabetes, and on child's weight and height at birth and 6 weeks of life.

NCT ID: NCT02796456 Completed - Obesity Clinical Trials

Determination of Maternal and Neonatal Apelinemia in Obese Women During Pregnancy

OB-APE
Start date: April 2016
Phase:
Study type: Observational

Background : Apelin and its receptor APJ have been implicated in pathologies including cardiovascular disease, diabetes and obesity. Little is known about the function of the apelinergic system during gestation. Objective : The main objective of this study is to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG). Strategy and method: A prospective research evaluating will be conducted to compare apelinemia in fasting normal weight and obese women at the end of pregnancy, between 35 and 41 weeks of gestation (WG). A third group will be created to check if gestational diabetes is not a confounding factor in obesity (group of obese women with gestational diabetes). Investigators will try to see if apelinemia is correlated to lipidic and glycemic markers. Samples will be collected in the cord blood to compare maternal and neonatal apelinemia and to see if neonatal apelinemia is correlated to the child's weight and birth size and to the weight of the placenta. Placenta samples will be collected and RT-qPCR will be done to analyze RNA in each group. Two days after delivery, obese and not obese women will be fasted and plasma and colostrum will be collected. Investigators will compare apelin levels in the colostrum between these 2 groups and then investigators will try to see if apelin level is correlated in the colostrum and in maternal plasma.

NCT ID: NCT02783612 Recruiting - Clinical trials for Gestational Diabetes

Digital Glucose Monitoring in Gestational Diabetes

Start date: March 2016
Phase: N/A
Study type: Interventional

Assessing blood glucose control in women with gestational diabetes can be challenging. The standard of care remains visual inspection of blood glucose paper diaries of self-performed capillary monitoring during regular meeting in High Risk pregnancy clinics. The researchers are interested in preforming a randomized control trial comparing women with the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital monitoring using an application in a Smart-phone and submitting those values via email in addition to the regular clinic appointments. The Primary outcome of the trial is to assess the compliance of the research group as compared to the control group.