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71 Gestational Diabetes Trials Near You
Power is an online platform that helps thousands of Gestational Diabetes patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerLifestyle Changes for Gestational Diabetes
Chapel Hill, North Carolina
To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, Multiple Gestation, Major Fetal Anomaly, Serious Medical Co-morbidity, Serious Psychiatric Illness, Others
416 Participants Needed
Continuous Glucose Monitoring for Type 2 Diabetes in Pregnancy
Chapel Hill, North Carolina
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are:
1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose?
2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose?
3. What other factors increase the risk of maternal and infant complications?
Participants will:
1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery
2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis
3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits
4. Have umbilical cord blood collected at delivery for analysis
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Multiple Gestation, Major Fetal Anomaly, Others
Must Be Taking:Insulin, Hypoglycemics
564 Participants Needed
Self-Administered Glucose Test for Postpartum Diabetes Screening
Greenville, South Carolina
The goal of this randomized controlled trial is to evaluate whether self-administered postpartum diabetes screening tests in patients with gestational diabetes improves screening completion rates. The primary question it aims to answer is:
1. Does a self-administered 75-gram oral glucose tolerance test with virtual follow-up visit increase the rate of postpartum diabetes screening within 12 weeks of delivery?
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
200 Participants Needed
Insulin Therapy for Gestational Diabetes
Rochester, New York
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pre-existing Diabetes, Multi-fetal Gestation, Others
Must Not Be Taking:Insulin, Corticosteroids
430 Participants Needed
Insulin Thresholds for Gestational Diabetes
Rochester, New York
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a strict and permissive threshold. The strict threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pre-existing Diabetes, Multi-fetal Gestation, Others
Must Not Be Taking:Insulin, Corticosteroids
430 Participants Needed
Insulin Management Strategies for Diabetes during Pregnancy
Greenville, South Carolina
There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM, and there is limited data among women with gestational diabetes. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with diabetes. Before neonatal benefit of ACS can be evaluated in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. Our long-term goal is to improve maternal and child health among women with diabetes as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims will determine the optimal strategy to achieve maternal glycemic control after ACS and inform a larger, multicenter trial to improve neonatal outcomes among women with diabetes and threatened PTB.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:0 - 50
Key Eligibility Criteria
Disqualifiers:Major Fetal Anomaly, Triplet, Others
Must Be Taking:Insulin, Metformin
120 Participants Needed
Food Program for Pregnancy Complications
Newark, Delaware
The purpose of this study is to conduct a pilot randomized controlled trial of a food is medicine community health worker intervention called the Women's Health Delaware Food Farmacy compared to the usual standard of care among pregnant ChristianaCare patients at risk for adverse clinical outcomes. The pilot study has three specific aims:
Aim 1: To assess the feasibility of the Women's Health Delaware Food Farmacy and refine the program as needed
Aim 2: To determine the prevalence of and change in social needs
Aim 3: To evaluate the effectiveness of the Women's Health Delaware Food Farmacy on maternal and child health, healthcare utilization, and clinical event outcomes as well as patient-reported outcomes compared to the usual standard of care
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Multiple Pregnancy, Others
250 Participants Needed
Group Prenatal Care for Gestational Diabetes
Saint Louis, Missouri
The investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Multiple Gestation, Major Fetal Anomaly, Serious Medical Comorbidity, Serious Psychiatric Illness, Others
117 Participants Needed
Inhaled Insulin for Gestational Diabetes
Philadelphia, Pennsylvania
Pregnant women aged 18-40 with gestational diabetes (GDM) will take part in this study. We want to see how two different insulin treatments affect their blood sugar after they eat. These women usually use a rapid-acting insulin analog (RAA) that's injected to control their blood sugar before and after meals. They will come to the clinic for two meal sessions. For the first meal, we will randomly decide if they will use the usual RAA insulin or a newer inhaled insulin called technosphere insulin (TI). They will use the other type of insulin for their second meal. After each meal, we will compare their blood sugar levels.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Type 2 Diabetes, Asthma, Smoking, Others
Must Be Taking:Rapid-acting Insulin
30 Participants Needed
Fiber Supplementation for Gestational Diabetes
Norfolk, Virginia
The hypotheses to be tested are 1) Fiber supplementation will decrease the need for medication in patients with gestational diabetes, and 2) Fiber supplementation will decrease adverse maternal and neonatal outcomes in these patients. In this study, the investigators will conduct a randomized controlled trial to limit bias in evaluating these hypotheses.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-English, Fetal Anomaly, Bowel Disorder, Phenylketonuria, Others
110 Participants Needed
Probiotics for Gestational Diabetes
Kingston, Ontario
This study is a single center randomized control trial of a probiotic based intervention in pregnancies complicated by gestational diabetes. A healthy gut microbiome is now recognized as a key component of human health and dysbiosis of the gut microbiome, including lack of diversity, is believed to contribute to the development of many diseases and alter glucose control. The study aims to explore whether this probiotic intervention will improve glucose control and change the gut microbiome. Participants may be enrolled and randomized after diagnosis of gestational diabetes between 24 and 31 weeks gestation. 115 participants will be randomized in a ratio of 2 in the probiotic intervention group to 1 in the placebo group. Participants will stop taking the intervention at 6 weeks postpartum. At this time, they will be unblinded and offered the option of participating in an open-label extension of the intervention until 6 months postpartum.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:16+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Severe Hypertension, Preeclampsia, Substance Use, Others
Must Not Be Taking:Antibiotics, Antifungals, Immunosuppressants
173 Participants Needed
Mobile App for Gestational Diabetes
Augusta, Georgia
To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Non-English, Others
40 Participants Needed
Insulin Aspart for Gestational Diabetes
Iowa City, Iowa
Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Tobacco Use, Diabetes, Hypertension, Others
Must Not Be Taking:Statins, Antihypertensives
40 Participants Needed
NADPH Oxidase Role in Gestational Diabetes
Iowa City, Iowa
This trial examines how an enzyme might create harmful molecules that damage blood vessels in healthy women who had diabetes during pregnancy. Researchers use a small, minimally invasive technique to deliver medicine directly to the skin and take cell samples from a vein to study stress markers.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Skin Diseases, Tobacco Use, Diabetes, Others
Must Not Be Taking:Statins, Antihypertensives
40 Participants Needed
Metformin for Post-Gestational Diabetes
Iowa City, Iowa
The purpose of this investigation is to examine the mechanisms mediating vascular dysfunction in women who have had gestational diabetes and how metformin may be a valuable treatment tool to improve microvascular function in these women before the onset of disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Prediabetes, Diabetes, Tobacco, Others
Must Not Be Taking:Cardiovascular, Metabolic
30 Participants Needed
The purpose of this investigation is to examine the role of oxidative stress in aberrant microvascular function in otherwise healthy women with a history of GDM.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Skin Diseases, Tobacco Use, Diabetes, Others
Must Not Be Taking:Statins, Antihypertensives
28 Participants Needed
Continuous Glucose Monitor for Gestational Diabetes
New York, New York
This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Multiple Gestation, Preexisting Diabetes, Others
Must Not Be Taking:Steroids
150 Participants Needed
Blood Glucose Monitoring for Gestational Diabetes
New York, New York
The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating.
The primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as \<80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Type 2 Diabetes, Others
140 Participants Needed
Choline Supplements for Gestational Diabetes
Brooklyn, New York
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.
Trial Details
Trial Status:Recruiting
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
60 Participants Needed
GPT-based Counseling for Gestational Diabetes
Bronx, New York
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pre-existing Diabetes, High-risk Pregnancies, Others
80 Participants Needed
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"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
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"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
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Delivering HOPE for Gestational Weight Gain
Corning, Arkansas
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 44
Sex:Female
1440 Participants Needed
PET Scans for Heart Disease Risk Assessment in Women
Ottawa, Ontario
The full HER CROWN will be a prospective cohort study to propose a novel, women-specific cardiovascular risk score/ algorithm in the prediction of hard cardiovascular outcomes (myocardial infarction, unstable angina, coronary revascularization, stroke, total and cardiovascular mortality). This future study will be the first longitudinal cohort study, to our knowledge, that is focused entirely on researching the pathophysiology and natural history of cardiovascular disease in women with known female-specific risk factors. Further, the investigators are aiming to recruit a sample that is representative of the ethnic distribution in Canada. The proposed pilot study is a feasibility study as an essential preparatory step for HER CROWN.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Male, Pregnant, CVD, Neurodegenerative, Others
210 Participants Needed
Induction of Labour for Gestational Diabetes
Ottawa, Ontario
The EAGER pilot trial is designed to assess the feasibility of a Canadian, multicentre prospective randomized open-label blinded end-point (PROBE) clinical trial addressing whether induction of labour (IOL) at 38 weeks' gestation compared to expectant management (EM) reduces severe perinatal mortality and morbidity among individuals with gestational diabetes mellitus (GDM). Eligible participants will be recruited between 36 weeks + 0 days and 38 weeks + 0 days gestation. Participants will be randomized to one of two arms:
* Intervention Arm: IOL between 38 weeks + 0 days and 38 weeks + 6 days OR
* Control Arm: EM without intervention until spontaneous labour, or earlier if a medical indication arises.
A total of 260 participants (130 per group) will be recruited from Canadian sites, where participants will have 3 study visits:
1. Enrollment and randomization
2. After delivery and up to 72 hours postpartum
3. 6 weeks postpartum At enrollment and randomization, patient-reported baseline and clinical data from medical charts will be collected. Upon admission to hospital for labour and delivery, a blood sample will be collected to assess HbA1C and plasma glucose levels. After delivery and up to 72 hours postpartum, study feasibility will be assessed through patient-reported outcomes and administrative and clinical data. At 6 weeks postpartum, participants will be surveyed for secondary health resource use. Findings from this pilot will inform the design, implementation and feasibility of a future full-scale randomized controlled trial.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pre-pregnancy Diabetes, Hypertension, Preeclampsia, Prior Cesarean, Others
Must Not Be Taking:Low Molecular Weight Heparin
260 Participants Needed
Continuous Glucose Monitoring for Gestational Diabetes
New Haven, Connecticut
This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregestational Diabetes, Fetal Anomalies, Lupus, Others
Must Be Taking:Diabetes Medications
80 Participants Needed
Metformin for Preventing Type 2 Diabetes After Gestational Diabetes
Worcester, Massachusetts
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.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pre-gestational Diabetes, Others
Must Not Be Taking:Systemic Steroids
116 Participants Needed
Early Detection Screening for Gestational Diabetes
Worcester, Massachusetts
The purpose of this study is to develop an implementation protocol and test the feasibility and acceptability of a first trimester screening protocol for the early detection of gestational diabetes mellitus (GDM).
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregestational Diabetes, Others
Must Not Be Taking:Systemic Steroids
80 Participants Needed
Post-meal Walking for Gestational Diabetes
Providence, Rhode Island
This is a randomized controlled trial to assess the effect of routine exercise counseling compared to the recommendation for postprandial ambulation on infant birthweight among pregnant people with gestational diabetes mellitus.
The primary outcome is birthweight percentile for gestational age at delivery.
Secondary outcomes include feasibility and acceptability, need for metformin or insulin for glycemic control, mode of delivery, neonatal hypoglycemia.
Participants will be counseled to either complete 20 minutes of walking after meals, or be counseled with routine exercise counseling of 30 minutes of low-impact 5x a week. Their activity will be tracked by "FitBit" pedometers and uploaded via bluetooth to a database for review. They will continue to receive routine obstetric and diabetes care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
90 Participants Needed
Metformin for Preventing Type 2 Diabetes After Gestational Diabetes
Boston, Massachusetts
This study is testing whether daily metformin for 1 year postpartum can reduce risk of diabetes in patients who had gestational diabetes. Typical care for prediabetes after gestational diabetes is counseling on diet and lifestyle. This study is researching whether management of diabetes prevention is more effective with the drug metformin. This study will be conducted at Tufts Medical Center.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
20 Participants Needed
Malama App for Gestational Diabetes
Boston, Massachusetts
Without intervention, approximately 70% of women diagnosed with GDM will develop type 2 diabetes mellitus in their lifetime. Abnormal results of a 2 hour oral glucose tolerance test (OGTT) performed as early as 2 days postpartum are predictive of impaired glucose tolerance 1 year postpartum. The investigators hypothesize that use of the Malama smartphone application to optimize antenatal glycemic control will result in lower incidence of postpartum glucose intolerance, which may decrease long term risk of progression to diabetes mellitus.
No Placebo Group
Trial Details
Trial Status:Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
30 Participants Needed
Nutritional Intervention for Gestational Diabetes
Québec, Quebec
Healthy eating during pregnancy has favorable effects on markers related to diabetes (glucose tolerance) and is associated with lower gestational diabetes mellitus (GDM) risk. The cornerstone of GDM treatment is nutrition therapy but the latter often starts late in pregnancy and thus may not have the expected effects on glucose tolerance. What if an intervention promoting healthy eating was initiated at the beginning of pregnancy in all women at risk, would it improve glucose homeostasis? To answer this important question, the investigators will perform a randomized controlled trial in 150 pregnant women. Women receiving the nutritional intervention will be compared to a control group receiving standard care. The nutritional intervention, which will start in the first trimester, is based on the 2019 Canada's Food Guide and is composed of 4 individual sessions with a registered dietitian (12, 18, 24 and 30 weeks). Between those follow-ups, informative nutritional web capsules and phone calls with the registered dietitian will be provided. To ensure that the women remain motivated and receive social support, a private Facebook group will be used. The investigators hypothesize that the nutritional intervention will be effective at improving glucose homeostasis. The investigators expect the results will show the importance of nutritional care starting early in pregnancy in women at risk of GDM.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Bariatric Surgery, Eating Disorder, Others
Must Not Be Taking:Corticosteroids
150 Participants Needed
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Frequently Asked Questions
How much do Gestational Diabetes clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Gestational Diabetes clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Gestational Diabetes trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Gestational Diabetes is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Gestational Diabetes medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Gestational Diabetes clinical trials?
Most recently, we added Lifestyle Interventions for Gestational Diabetes, Probiotics for Gestational Diabetes and Nutrition Programs for Postpartum Recovery to the Power online platform.
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