Clinical Research Directory

Effect of Intensive Nutrition Training, Education, and Support in Gestational Diabetes - The INTENSE-GDM TRIAL

The treatment of gestational diabetes (GDM) primarily revolves around consuming an optimal diet that does not cause blood glucose levels to become excessively high and provides an adequate supply of micro- and macronutrients without resulting in excessive weight gain during pregnancy. In some cases, it may become necessary to supplement with insulin during pregnancy. However, insulin treatment is associated with personal, health-related, and healthcare cost-related implications. The rationale for this study is the lack of knowledge regarding whether the extent of support and guidance from a dietitian during pregnancy has an impact on the treatment outcomes for both the mother and the child in cases of GDM. The overall objective is to investigate differences in clinical, cost-related, and patient-reported outcomes between women with GDM randomised to either intensive dietary therapy or standard dietary care (control). The primary endpoint is the effect of intensive dietary therapy on the likelihood of remaining treated with diet only vs. needing insulin therapy. The study design is a randomised controlled parallel group open-label effectiveness trial including 214 women with GDM.

Hong Kong Gestational Diabetes Register (HKGDR)

Gestational diabetes mellitus (GDM) is a common condition that affects approximately one out of every six pregnancies. It is defined by elevated levels of blood glucose during pregnancy, usually detected through a glucose challenge test conducted at approximately 24-28 weeks of gestation. Gestational diabetes, by nature of the elevated glucose levels during pregnancy, is known to be linked to an increased risk of some conditions in the mother. Furthermore, the elevated glucose, if not well controlled, can be linked to a higher birth weight in the baby, as well as other effects. Although it is known that women with gestational diabetes have higher risks of diabetes later in life, exactly why gestational diabetes increases the risk of diabetes is not entirely known. It is known that some of the genetic factors that are linked to gestational diabetes are also linked to diabetes risk. Furthermore, how elevated glucose during pregnancy may affect later generations is not entirely clear. This is a research study that aims to improve the postnatal follow-up of women with gestational diabetes. Currently, there are no standard recommendations on how women with gestational diabetes should be followed up after they have given birth. Furthermore, despite being at increased risk of other metabolic problems including high blood pressure, abnormal lipids, and obesity, these are not routinely being monitored after gestational diabetes. The study aims to enroll women with gestational diabetes into a multi-center registry, where they will be provided with information about the long-term risks of metabolic diseases and be reminded to undergo regular assessments to monitor their health status, including assessment of glucose status, monitoring of blood pressure, as well as other parameters. Regular assessments will be provided for the initial 3 years. A subgroup of participants will also be invited to participate in a separate study of a lifestyle intervention program to reduce their risk of developing diabetes. It is hoped that results from this study will help guide the development of care programs to better monitor the health of women after pregnancies complicated by gestational diabetes, which will help improve the overall health of the population. In addition, the study aims to identify clinical factors, genetic and other biological biomarkers, as well as algorithms to predict different clinical outcomes and categorize participants into different subtypes of gestational diabetes, in order to optimize future treatments according to the characteristics of each individual.

Study to Prevent Dysglycemia in Women With GDM

Women with a history of gestational diabetes mellitus (GDM) have a 7-fold increased risk of type 2 diabetes (T2D), with the risk at its highest during the 3-6 years postpartum. GDM thus represents one of the strongest known risk factors for T2D. Only 30-60% of women with GDM returned for postpartum visits, with the majority defaulting on postpartum glucose tolerance testing. Women with GDM also have an increased risk of hypertension, cardiovascular disease (CVD), non-alcoholic fatty liver disease, and other comorbidities. Through this study, participants will receive lifestyle advice that may help them prevent diabetes. The study will help determine whether a multicomponent intervention will prevent incident dysglycemia and improve offspring cardiometabolic health. This will inform healthcare professionals and policymakers if these interventions are helpful. The control group will receive basic dietary information leaflets and will have access to the e-care platform for the three-year period (8-166 weeks postnatal). They will receive routine lifestyle advice and counseling. The intervention groups will receive information on basic dietary information and have access to the e-platform. Participants will attend individualized/group dietary counseling sessions biweekly in the first 4 months during the intensive phase (V1-V7) and thereafter bimonthly (V8-10, 28-50 weeks postnatal) and biyearly between year 1 to year 3. This will include 16 sessions with a dietitian/nutritionist and 4 sessions with an exercise instructor. Participants will be given an individualized menu plan aiming at achieving a varied, balanced diet with an emphasis on fiber intake and moderate-carbohydrate, low-fat, low-glycemic index products in appropriate portions. The lifestyle intervention program will incorporate motivational interviewing and behavioral modification to enhance health knowledge on daily diet and physical activity. The lifestyle intervention aims to achieve targets on body weight, dietary intake, and physical activities.

Gestational Lifestyle & Outcomes Wellness

A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)

Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia

This study aims to explore whether early intervention for high-risk groups of gestational hyperglycemia can improve insulin resistance and effectively prevent the occurrence of GDM, and evaluate which pathophysiological subtypes of GDM have the best effect on improving maternal and fetal adverse prognosis, so as to provide evidence for stratified management and individualized clinical intervention of high glucose groups in pregnancy

DiGESTnewborn Study

We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth.

Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

This study aims to comprehensively evaluate the multifaceted impacts of Lactobacillus rhamnosus LRa05 on patients with gestational diabetes. Initially, the study will investigate the effects of LRa05 on improving patients' blood glucose levels and gut microbiota. Additionally, the study will assess the impact of this strain on patients' blood lipid levels, inflammatory markers, and body mass index (BMI). Furthermore, the study will also focus on its effects on thyroid function, vaginal microbiota, and bile acid metabolism in patients with gestational diabetes.

Time to Move in Pregnancy Hyperglycemia

This randomized controlled crossover trial of 36 pregnant individuals with gestational diabetes (GDM) or gestational glucose intolerance (GGI) will: 1. Determine the effects of physical activity (PA) timing, specifically 30 minutes of moderate intensity walking or stepping in the morning (between 5am-9am, within 30-40 minutes of starting breakfast), versus late afternoon/evening (between 4pm-8pm, within 30-40 minutes of dinner) on glucose across the 24-hour cycle. 2. Explore the potential effects of the timing of PA on sleep and mood state.

White Adipose Tissue in Pregnancy Study

This study aims to understand the role of metabolic tissues in the changes of the metabolism of pregnant women and whether this contributes to some women developing metabolic diseases of pregnancy such as gestational diabetes (GDM) or intrahepatic cholestasis of pregnancy (ICP). Samples of adipose tissue will be taken when pregnant women are having caesarean section or laparoscopic procedures.

"Mantou" Screening for GDM Before 20 Weeks of Gestation

Gestational diabetes mellitus (GDM) can occur in overweight, hyperinsulinemia, insulin resistance pregnant women, or lean, insulin deficiency pregnant women. At least 5% of all pregnant women will develop GDM, which is even higher among Asians. Poor control of GDM in late pregnancy will increase the following risks: macrosomia, preeclampsia, shoulder dystocia, cesarean section, stillbirth and other risks. At present, the screening method for GDM is 75g of glucose OGTT test. However, when drinking sugared water on an empty stomach, the pregnant women will feel nausea, stomach burning, and hunger when waiting for blood drawing. Some women vomit after drinking sugared water, resulting in inaccurate test results and poor compliance, affecting the accuracy of diagnosis of GDM. "Sugar tolerance Mantou" has been used for screening diabetes since 1982. It is made of 100g flour and contains 75g glucose of the same amount. It is a feasible method to use Mantou instead of sugar powder to screen GDM. Mantou is an acceptable diet for Chinese people, which greatly reduces nausea, vomiting, hunger and other discomfort, and increases GDM screening rate. At present, the cesarean section rate in China remains high, and the weight and nutritional management of pregnant women are not satisfied. Many pregnant women, especially those in country-level areas, have already gained excessive weight when referred from to delivery hospitals, leading to an increase in pregnancy complications such as preeclampsia and macrosomia, increasing the cesarean section rate and delivery risk. Therefore, it is necessary to screen GDM in advance. Moving forward the screening of GDM and strengthening the management of pregnant women's weight can effectively reduce the occurrence of pregnancy complications.

Study on Serum Metabolomics of GDM

This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. This study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of GDM.