Clinical Research Directory

Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes

This study involved two management protocols to manage diabetes in pregnancy. Sixty patients having GDM will be recruited on the basis of the OGTT and randomly allocated to two management groups. One group of patients will receive counselling and the conventional method of management. while the other group will receive a tailored diet plan and physical activity with low caloric and moderate intense exercises. Both groups will receive a dietary plan based on their sugar levels weekly basis and physical activity with pharmacotherapy to adjust their sugar levels, while the intensive group will have rigorous monitoring on a monthly basis and frequent visits with repeated lab checks. This will help us to reduce short and long-term complications with improved maternal and neonatal outcomes.

Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening

The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.

Pregnancy and Postpartum CGM in GDM

Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.

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.

Pragmatic Randomized Clinical Trial to Limit Weight Gain in Pregnancy and Prevent Obesity

Healthy for Two, Healthy for You (H42/H4U) is an innovative evidence-based pregnancy/postpartum health coach intervention that is remotely-delivered (phone coaching using motivational interviewing, web-based platform, mobile phone behavioral tracking). The aim of this randomized controlled trial (RCT) is to embed H42/H4U into Johns Hopkins prenatal care clinics that serve a racially and economically diverse population, leveraging existing staff as trained health coaches to test its effectiveness and implementation. The investigators hypothesize that women in the H42/H4U arm will have lower gestational weight gain and lower rates of gestational diabetes, without an increase in low birth weight infants, and that implementation into the investigators' prenatal care clinics will be feasible and scalable.

Delivering HOPE (Helping Women Optimize Prenatal Equity)

The overarching research question is: "Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.

Preventing T2DM After GDM With Immediate Postpartum Screening

The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.

The Laughter, Pregnancy, Anxiety and Llife Quality

Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy. Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.

EMERGE Mothers and Kids

The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality. The primary objectives of the EMERGE Mothers and Kids follow up study are: 1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 10 years post the index pregnancy; 2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration; 3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up; 4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.

Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus

1. To compare the effects of metformin, insulin, and their combination with multistrain probiotics on glycemic control and insulin resistance in women with gestational diabetes mellitus (GDM), assessed by FPG, HbA1c, fasting insulin, and HOMA-IR. 2. To compare the effects of metformin, insulin, and their combination with multistrain probiotics on inflammatory biomarkers in women with GDM. 3. To determine the effect of multistrain probiotic supplementation alongside standard therapy on maternal and neonatal outcomes, including gestational age at delivery, mode of delivery, birth weight, Apgar score, and NICU admission.

Evaluating the Efficacy of GPT-based Nutrition and Diabetic Counseling in Gestational Diabetes Management: A Randomized Controlled Trial (AIM-GDM)

The purpose of this study is to assess whether an AI based counseling service can be beneficial for patients to assist in management of gestational diabetes.

Continuous Glucose Monitoring to Detect Postpartum Dysglycemia in Patients With Gestational Diabetes

The aim of this study is to determine the ability of postpartum continuous glucose monitoring (CGM) for subjects with gestational diabetes (GDM) to predict dysglycemia on 4-12 week postpartum oral glucose tolerance test (OGTT).

Continuous Glucose Monitoring for Women With Gestational Diabetes

There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian-Australian open-label multi-centric RCT with 16 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3 +) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.

Mobile-based Obstetric Monitoring for Pregnancies Complicated by Hypertension and/or Diabetes (MOM-HD)

Hypertensive disorders during pregnancy (HDP) and gestational diabetes (GDM) are among the leading complications in pregnancy, significantly contributing to global maternal and fetal morbidity and mortality. (1,2,3) Effective management of HDP and GDM hinges on regular monitoring of blood pressure (BP) and blood glucose (BG) to ensure adequate control and timely interventions for maternal and fetal well-being. Telemonitoring offers a promising and cost-effective alternative by enabling pregnant individuals to monitor BP and BG at home and share real-time results with healthcare providers, facilitating informed clinical decision-making and timely interventions. Here the investigators propose to conduct a Hybrid Type II Effectiveness-Implementation Randomized Controlled Trial (RCT) to assess the effectiveness and evaluate the implementation of the MOM-HD (Mobile-based Obstetric Monitoring for Hypertension and/or Diabetes) program, a mobile app-based perinatal telemonitoring program, in real-world clinical settings in Nepal. To address the study aims, the investigators will recruit 864 women who are newly diagnosed with HDP and GDM from three metropolitan hospitals and randomly assign them to either (i) MOM-HD + standard care or (ii) standard care alone, from enrolment in pregnancy to 6 weeks postpartum. Primary and secondary clinical outcomes will be assessed at delivery, and at 6 weeks postpartum. The investigators hypothesize that compared to standard care, the use of MOM-HD in addition to standard care will result in lower systolic BP levels, lower incidence rate for the composite adverse perinatal outcome of either perinatal loss, neonatal intensive care unit admission, primary cesarean delivery or labor induction, and lower proportion of days with elevated systolic BP or BG readings between recruitment and 6 weeks postpartum. A convergent mixed-methods approach will be used to assess implementation and maintenance outcomes using the RE-AIM framework (4), and economic sustainability will be assessed by collecting primary cost data.

Preventing Obstetric Complications With Dietary Intervention

The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are: * Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns? * Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups. Participants in the standard of care will be asked to: * Complete surveys * Biometric screenings Participants in the intervention group will be asked to: * Complete surveys * Biometric screenings * Participate in weekly personal health coaching * Receive and consume provided weekly meals. Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.

Growth Hormone Resistance of Beta-cells A

The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with a personal history of gestational diabetes (high blood sugar in pregnancy) at the University of Missouri. The aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing gestational diabetes.

Community Health Worker-Led Postpartum Diabetes Screening

Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population. A substudy will also test the effectiveness of a timed protein-fiber supplement in glucose control.

Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes

This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, the investigators will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps the participants' pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, the investigators hope to find out if exenatide might also be helpful in gestational diabetes.

Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)

The goal of this clinical trial is to see if diabetes in pregnancy can be treated with once daily dosing of insulin instead of once daily dosing plus insulin with meals. The main question this study aims to answer is: 1. Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin? 2. Do babies born to mothers who take one dose of long-acting insulin have more complications after birth than babies born to mothers who take long-acting and meal-time insulin? Researchers will compare one dose of long-acting insulin per day to this plus three doses of short-acting insulin with each meal to see if blood sugars are controlled. Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.

Glycemic Observation and Metabolic Outcomes in Mothers and Offspring

The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal glycemia over the course of pregnancy and to evaluate how glucose levels throughout pregnancy relate to traditional third trimester gestational diabetes mellitus (GDM) screening and perinatal outcomes.

PRIOR Study (Pre-eclampsia Risk In Oocyte Recipients)

The aim of this prospective observational cohort study is to investigate the pathophysiological mechanisms behind and risk of pre-eclampsia in women pregnant after fertility treatment with oocyte donation. The participants are included in of of two cohorts. One includes women pregnant after oocyte donation whereas the other includes women pregnant after IVF treatment with autologous oocytes. Participants will be followed throughout pregnancy with blood samples, blood pressure, clinical controls and ultrasound examinations. Clinical outcomes will be registered post-partum.

Pregnancy Cohort Study: Pregnancy as a Window to Future Health

The goal of this observational cohort study is to gain deep insights into how metabolic disorders such as obesity or diabetes during pregnancy affect the metabolic and cardiovascular health of mother and child in the short and long term. It will investigate the following questions: * How do maternal metabolic disorders affect pregnancy outcomes? * How do maternal metabolic disorders affect fetal growth? * How do maternal metabolic disorders affect the newborn's metabolism and body composition? * How do maternal metabolic disorders during pregnancy affect breast milk composition? * How do maternal metabolic disorders during pregnancy affect the metabolic health of the mother after birth? Participants in this study are pregnant women who will be asked to come to the clinics for three visits during their pregnancy, as well as for the delivery of their baby, and one time 2-3 months thereafter. At each visit, researchers will perform physical examinations (such as body composition measurements) and collect biological samples (blood, urine, saliva), clinical information, and lifestyle data. At birth, researchers will collect cord blood and breast milk as well as clinical data of the delivery and the health of the baby. Researchers will measure body fat in newborn babies and at 2-3 months of age.

Preconception Lifestyle Interventions to Improve Future Metabolic Health (Before the Beginning)

The aim of this study is to investigate whether the combination of high intensity exercise and time restricted eating before and during pregnancy can reduce the risk of hyperglycaemia during pregnancy.