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135 Pre Diabetes Trials Near You
Power is an online platform that helps thousands of Pre 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 PowerWalking Environments for Prediabetes
Lake Forest, Illinois
Approximately 92 million U.S. adults (\~38% of population) have prediabetes (PreD). Because people with PreD are at high risk CMD, they are a target population for diabetes prevention programs. The focus is people with PreD because of their high risk for developing CMD and large numbers, providing an opportunity to investigate behavioral and environmental approaches as preventive measures in a well-defined population. Urbanization affords challenges and opportunities to public health that include exposure to obesogenic environments, air pollution, and psychosocial stressors. In healthy adults suggest exposure to nature has health benefits relative to exposure to built environments. Hypothesized mechanisms for health benefits of Greenspace exposure include increased physical activity (PA), attention restoration, stress reduction, and reduced exposure to pollution. Many of the health benefits are associated with reduced psychological and physiological stress leading to better autonomic functioning as assessed by heart rate variability (HRV) and other biomarkers. Multiple studies suggest that PA and exposure to natural environments may act together to improve health. Yet, aside from our preliminary studies, we are not aware of any studies that examined how physical activity may interact with exposure to urban Greenspace ('Green') compared with built urban environments ('Gray'), to reduce stress and improve health. The purpose of this proposed study is to conduct a randomized crossover trial comparing differences in the psychosocial and physiological effects of walking in urban Green and Gray spaces in adults with PreD.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 64
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular Disease, Cancer, Others
Must Not Be Taking:Diabetic Medications, Arrhythmia Medications
216 Participants Needed
Plant-Based Supplement for Body Fat
Addison, Illinois
The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.
Trial Details
Trial Status:Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
150 Participants Needed
Empagliflozin for Prediabetes
Asheville, North Carolina
Prediabetes effects 96 million people 18 years of age or older. It is important to identify treatment options to slow or prevent progression to diabetes. It is also critical to assess the potential of medications like sodium glucose transporter 2 inhibitors to reduce the risk of cardiovascular events and kidney complications, both common and costly complications of diabetes. This is a 12-week, open-label pilot feasibility study assessing the use of empagliflozin in prediabetes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:35 - 60
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Neurogenic Bladder, Others
Must Not Be Taking:Antihyperglycemics, Weight Loss Agents
60 Participants Needed
Bilingual Intervention for HIV/AIDS-Related Food Insecurity
Winston-Salem, North Carolina
This trial tests a program to help people with HIV who don't have enough food. It aims to improve their blood sugar levels by ensuring they have enough to eat. The goal is to reduce the risk of diabetes and related health issues.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Others
200 Participants Needed
NDPP-NextGen for Diabetes Risk Reduction
Winston-Salem, North Carolina
The goal of this clinical trial is to test an enhanced version of the National Diabetes Prevention Program (NDPP-NextGen) that is tailored to young women in childbearing years. The investigators will recruit 360 women aged 18-39 years with overweight/obesity who are not currently pregnant, but likely to conceive within 24 months. Women will be randomized to NDPP-NextGen or a usual care control group. The NDPP-NextGen group will participate in the adapted NDPP online group class across 12 months, and the control group will get a packet of information about how to be healthy before, during and after pregnancy.
The main goals of the study are:
1. to assess effects of NDPP-NextGen on pre-pregnancy blood sugar and early pregnancy BMI
2. to assess effects of NDPP-NextGen on weight gain and behavioral outcomes during pregnancy
3. to explore effects of NDPP-NextGen on infant's percentage of fat tissue at birth
All participants will complete up to 4 research visits: baseline, conception, mid-pregnancy, and delivery. These visits will include:
1. Questionnaires about health, diet, activity, smoking, self-confidence, and depression
2. Body size measurements
3. Fasted blood draws
Participants will also be asked to weigh themselves weekly using home scales that are connected to the research database. At the delivery visit, investigators will measure the baby's body size and collect a cord blood sample.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 39
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Diabetes, Long-acting Contraceptives, Others
403 Participants Needed
Soy Milk for Metabolic Health
Toronto, Ontario
Strategies to reduce sugar-sweetened beverages (SSB) have become one of the leading public health targets to address the epidemics of obesity and diabetes. National food, nutrition, and health policies and programs have positioned low-fat milk as the preferred caloric replacement strategy for SSBs. This strategy derives from evidence that replacement of SSBs with low-fat milk is associated with reductions in weight and incident diabetes in prospective cohort studies and reduces liver fat (an important early metabolic lesion linking obesity to diabetes), as well as triglycerides and blood pressure in randomized trials. Whether these benefits hold for soy milk alternatives is unclear. There is an urgent need for studies to clarify the benefits of soy milk as an alternative to cow's milk. Our overarching aim is to produce high-quality clinical evidence that informs the use of soy as a "public health intervention" for addressing the dual epidemics of obesity and diabetes and overall metabolic health. To achieve this aim, we propose to conduct the Soy Treatment Evaluation for Metabolic health (STEM) trial, a large, pragmatic, randomized controlled trial to assess the effect of using 2% soy milk (soy protein vehicle) versus 2% cow's milk (casein and whey vehicle matched for protein and volume) as a "public health intervention" to replace SSBs on liver fat and key cardiometabolic mediators/indicators in an at risk population.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
186 Participants Needed
Early vs Late Dinner for Obesity
Bethesda, Maryland
Obesity and its metabolic complications are leading causes of global morbidity and mortality. Evidence is mounting that inappropriate timing of food intake contributes to obesity. Specifically, late eating is associated with greater weight gain and metabolic syndrome. However, the mechanism by which late eating harms metabolism is not fully understood but may be related to mis-timing of food intake in relation to the body's endogenous circadian rhythm. Conversely, harmonization of eating timing with endogenous circadian rhythm may optimize metabolic health. In this study the investigators will use gold-standard methods of characterizing circadian rhythm in humans to examine the metabolic impacts food timing relative to endogenous circadian rhythm.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Sleep Disorders, Diabetes, Cardiovascular Disease, Others
Must Not Be Taking:Diabetes Medications, Psychiatric Medications
32 Participants Needed
Time-Restricted Eating for Type 2 Diabetes
Toronto, Ontario
This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Bariatric Surgery, Cognitive Disorder, Others
Must Not Be Taking:Exogenous Insulin, Sulfonylureas, Antiobesity Medications
120 Participants Needed
Lifestyle Changes + Metformin for Diabetes Prevention
Rockville, Maryland
The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development of diabetes in a high risk population due to the presence of impaired glucose tolerance (IGT, 2 hour glucose of 140-199 mg/dl). The DPP has ended early demonstrating that lifestyle reduced diabetes onset by 58% and metformin reduced diabetes onset by 31%.
DPPOS (2002-2013) is designed to take advantage of the scientifically and clinically valuable DPP participants. This group of participants is nearly 50% minority and represents the largest at risk population ever studied. Clinically important research questions remain that focus on 1) durability of the prior DPP intervention, 2) determination of the clinical course of precisely known new onset diabetes, in particular regarding microvascular disease, CVD risk factors and atherosclerosis, 3) close examination of these topics in men vs women and in minority populations.
The major aims of DPPOS-3 (2014-2025) take advantage of the long-term randomized exposure of the study cohort to metformin and the aging of the DPPOS cohort. The metformin exposure and high degree of study retention and adherence (\~85% of the DPPOS cohort continues to attend annual and mid-year visits) allows DPPOS-3 to examine the long-term effects of metformin on cardiovascular disease (CVD) and cancer outcomes, outcomes of great clinical interest and import.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Age:25+
Key Eligibility Criteria
Disqualifiers:Not Listed
2779 Participants Needed
Produce Prescription for Prediabetes
Washington, District of Columbia
In this randomized control study, participants will be randomized 1:1 to either participate in the YMCA's Produce Prescription Program (YPRx) and receive weekly deliveries of fresh produce bags for their household or to receive YPRx plus participate in the Diabetes Prevention Program (DPP).
The investigators hypothesize that participants randomized to receive YPRx plus DPP will have greater weight loss, increased physical activity, improved diet quality and behaviors, increased food security, improved self-rated health assessment, decreased healthcare utilization from baseline to endline (12 months) compared to those randomized to receive YPRx produce deliveries only.
We will also collect data on process measures for implementation purposes.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Others
150 Participants Needed
High-Fat Diet for Insulin Resistance
Washington, District of Columbia
The purpose of this study is to understand how the body's response after a meal is influenced by insulin and sugar in the blood. The primary question this study seeks to address is what is the effect of reduced insulin sensitivity on postprandial metabolic flexibility to an oral glucose tolerance test. We will recruit 50 adults (ages 20-45; 50% female) who are otherwise healthy (no known clinical diagnosis) into our non-randomized crossover trial to determine the effect of changes in insulin sensitivity on metabolic response to feeding. Insulin sensitivity will be decreased using a three-day high-fat diet (HFD) with extra calories. Whole-body metabolism will be measured during a standard 75-gram oral glucose tolerance test (OGTT). Metabolic response to feeding (e.g. OGTT) will be compared before and after the HFD and compared with the control diet to understand the effect of decreased insulin sensitivity on the metabolic response to feeding. The role of biological sex as a moderator of the effect of increased insulin resistance on postprandial metabolic flexibility will also be investigated
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:20 - 45
Key Eligibility Criteria
Disqualifiers:Pregnancy, Eating Disorders, Gastrointestinal Diseases, Others
Must Not Be Taking:Antioxidants, NSAIDs, Antibiotics, Others
50 Participants Needed
Plant-Based Diet for Weight Loss
Washington, District of Columbia
This prospective study aims to assess the feasibility and implementation of a plant-based, weight-loss program in an office setting. The study will also assess changes in body weight, blood pressure, plasma lipids, glycated hemoglobin, and body composition with a 12-week, plant-based, weight-loss program. These health benefits may illustrate feasibility to physicians and healthcare professionals elsewhere.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Recreational Drugs, Pregnancy, Unstable Illness, Others
75 Participants Needed
Community Health Promotion for Reducing Health Disparities
Washington, District of Columbia
The Community Engagement Alliance against Disparities - Washington District of Columbia, Maryland, Virginia (CEAL DMV), is a multi-community and multi-university consortium. Through collaboration and shared leadership, the CEAL-DMV the consortium- comprising five institutions: George Washington University, Howard University, Johns Hopkins University, Morgan State University, and the University of Maryland, Baltimore-has established a regional structure for bi-directional community involvement to engender trust and foster communication. Each site builds on thriving community partnerships, which have been instrumental in enhancing trust, community capacity, and readiness to reduce health disparities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:No Phone/internet, Others
664 Participants Needed
Postpartum Follow-Up Card for Enhancing Postpartum Care
Washington, District of Columbia
The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge.
The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated.
Trial Details
Trial Status:Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
240 Participants Needed
Exercise Interventions for Prediabetes Fatigue
Milwaukee, Wisconsin
Pre-diabetes (Pre-D) is a precursor to type 2 diabetes (T2D) and characterized by increased exercise fatigability of lower limb muscles, that can impede exercise performance. The cause for the increased fatigability in people with Pre-D is not known. Given the profound vascular disease present in people who have had uncontrolled diabetes for several years, we will determine whether dynamic, fatiguing contractions of the lower limb muscles in people with Pre-D are limited by vascular dysfunction at multiple levels along the vascular tree including the artery, arteriole, and/or capillary. This clinical trial involves a novel exercise training regime involving blood flow restriction to the exercising limb will be used as a probe to further understand the vascular mechanisms for increased fatigability in people with Pre-D and T2D. The long-term goal is to better understand what limits exercise and functional performance in people with diabetes to help develop targeted, more effective exercise programs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:30 - 85
Key Eligibility Criteria
Disqualifiers:Neuropathy, Severe Obesity, Smoking, Others
Must Not Be Taking:Insulin, Hormone Replacement
80 Participants Needed
Whole Foods Diet for Prediabetes
Nashville, Tennessee
This study will address the following aims:
Aim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet.
Feasibility: ≥80% participant retention and completion of study outcome measures.
Acceptability: ≥75 adult diet satisfaction via survey report and/or perceived diet satisfaction via focus groups. Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult/child diet quality during the 12-week intervention.
Aim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes.
Hypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group.
Aim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group.
Aim 3: Conduct family focus groups to understand how SDOH and individual/family needs and preferences may be perceived barriers or facilitators of diet adherence.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:6 - 59
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, Pregnancy, Others
Must Not Be Taking:Diabetes Medications, Weight Loss Drugs
30 Participants Needed
Dietary Intervention for Preventing Pregnancy Complications
Milwaukee, Wisconsin
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.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Renal Disease, Bowel Disease, Others
Must Not Be Taking:Psychotropics, Corticosteroids
100 Participants Needed
Decision Support Tool for Prediabetes
Lutherville, Maryland
The investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. The investigators objective is to design and pilot test a prediabetes clinical decision support (CDS) tool in the electronic health record (EHR) that will assess the patient's activation level based on responses to a questionnaire. Based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, DPP) to support patient activation.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Diabetes, Non-English, Severe Psychiatric, Others
100 Participants Needed
Sit-stand Desk for Diabetes Prevention
Milwaukee, Wisconsin
More than 84 million - or 1 out of every 3 U.S. adults - have prediabetes, a condition that if not treated often leads to type 2 diabetes within five years. Average medical expenditures among diabetics are about 2.3 times higher than expenditures for people without diabetes. Physical inactivity and elevated body mass index (BMI) are major risk factors for the disease. Sedentary behavior is becoming increasingly prevalent with the growth of a 'work from home' culture, most recently driven by the COVID-19 pandemic. Cross-sectional epidemiologic data report significant associations between high amounts of sedentary (sitting) time and prevalent cardiovascular disease and diabetes. In our pilot study of 15 subjects with sedentary office jobs, 6 months of sit-stand desk use resulted in a 23% improvement in insulin resistance, most substantial in those who decreased daily sitting by over 90 minutes/day. Additional improvements in vascular endothelial function and triglyceride levels were seen without any change in exercise activity, step counts, or body weight. These findings not only corroborate epidemiologic findings on this topic but suggest causality and warrant a randomized control trial.
The investigators hypothesize that adult subjects at-risk for diabetes will improve insulin sensitivity, metabolic and vascular (endothelial) health with a sit-stand desk intervention at work (whether in the office or at home), in the context of a randomized, controlled trial. The investigators will randomize 198 sedentary office workers with a BMI≥25 at risk for type 2 diabetes mellitus in a 1:1:1 ratio of three groups: (a) sit-stand desk intervention targeting 2 hours standing per day; (b) sit-stand desk intervention targeting 3 hours standing per day; or (c) control arm over 6 months. The block randomization design will allow for important dose-response analyses.
The investigators will objectively quantify standing time, sedentary time, sedentary bouts, daily steps, and exercise activity times using a compact and re-usable accelerometer that adheres to the subject's thigh. This will provide objective assessments of activity levels and sedentary times for 7 full days each at baseline, 3 and 6 months. The device is equipped with an inclinometer to classify posture (sitting verses standing).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Diabetes, Musculoskeletal Disorders, Neuropathy, Others
Must Not Be Taking:Diabetes Medications, Insulin, Steroids
198 Participants Needed
Electronic Medical Record Support for Diabetes Management
Hershey, Pennsylvania
The purpose of this study is to determine the impact of an electronic medical record clinical decision support tool on rates of dysglycemia in the hospital, and its clinical and economical outcomes. The study also evaluates the perspectives of providers regarding the tool's usefulness on disease management support, knowledge, and practice performance.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Children
15732 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"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."
WR
Obesity PatientAge: 58
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
Lifestyle Modification for Diabetic Neuropathy
Baltimore, Maryland
Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and early diabetes affects a considerably larger but unknown population group. At the current time there is no effective therapy to completely prevent, or reverse neuropathy associated with IGR and this represents a considerable challenge in rehabilitation. There is a particularly strong incentive to prevent IGT and related complications from advancing to DM2. IGR is a growing problem among all older adults and its strong association with many functional limitations, particularly mobility limitations, is not always recognized, even though diabetes-related disability occurs in up to 2/3 of older adults with diabetes and is associated with dependency, poor quality of life, and increased acute and long-term care utilization.
Autonomic dysfunction is a significant problem in subjects with IGT. The Preliminary Data shows that over 90% of subjects with IGT have an abnormal score on questionnaires about autonomic symptoms such as lightheadedness, dry mouth or dry eyes, pale or blue feet, feet that are colder than the rest of the body, decreased sweating in the feet or increased sweating in the hands, nausea or bloating after eating, persistent diarrhea or constipation, or leaking of urine. In addition, patients with IGR have impaired balance control. These factors can increase the risk of falls in affected subjects. A non-randomized and non-controlled study showed that a diet and exercise intervention in patients with diabetes led to an overall improvement in autonomic function. Furthermore, it was shown that standing balance can be improved with a balance intervention program.
However, there are no published studies that assess the effect of an intense physical activity intervention on autonomic function in IGR related neuropathy. This study will test an aerobic exercise and balance intervention in participants with IGR. The investigators will examine if an individually tailored, carefully monitored, Diet, Physical Activity, and Balance Enhancement Program (DPAEP) can improve autonomic function and balance control when compared to patients who receive standard care. Improving balance control and autonomic function can decrease the risk of falls and have a significant effect on the health of participants.
The research is also significant because it will test subjects either before they become diabetic, or at an early stage in their diabetes, thus enhancing the chance of reversing the autonomic neuropathy or balance impairment. Furthermore, the study is designed to test whether improvement in autonomic function and balance is associated with improvement in clinical outcomes, quality of life, and the metabolic state of participants. Thus, the proposed interventions are likely to have a real life impact on participants and their health.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:30 - 80
Key Eligibility Criteria
Disqualifiers:Pregnancy, Prisoners, Severe Conditions, Others
60 Participants Needed
Meal Timing for Blood Sugar Control
Baltimore, Maryland
The proposed study uses a novel and rigorous randomized cross-over study design in youth (17-23y) with late and non-late chronotype (n=35 per group) to assess the glycemic effect of "aligning" an oral glucose tolerance test (OGTT) or first-meal of day to a subject's chronotype. Both groups will undergo 2 OGTTs (aligned and mis-aligned with chronotype) to compare glucose tolerance and insulin sensitivity within-subject (primary outcome) and between groups (Aim 1). Then, youth will also undergo two standardized meals (aligned and mis-aligned with chronotype) while wearing continuous glucose monitoring to compare post-prandial glucose excursions within-subject and between groups (Aim 2). A pilot Exploratory Aim 3 (n=12 per group) will investigate delayed melatonin patterns under dim-light as a potential pathophysiologic mechanism behind abnormal glucose tolerance in youth with late chronotype on morning OGTTs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 23
Key Eligibility Criteria
Disqualifiers:Diabetes, Sleep Disorders, Pregnancy, Others
Must Not Be Taking:Insulin, Melatonin, Others
70 Participants Needed
Diabetes Prevention & Education for Prediabetes
Baltimore, Maryland
Type 2 diabetes mellitus is one of the fastest growing public health problems in developed and developing countries and imposes a large financial burden on health-care systems. Preventing, delaying, and managing diabetes should be a priority for health-care systems. Nationally, 38% of adults have prediabetes, with more than 80% of people with prediabetes being unaware of their condition. In Maryland, an estimated 10.5% of adults report prediabetes, and 33.7% of Baltimore City residents have obesity, an important risk factor for prediabetes.
The BMDRP aims to increase the capacity of BMDRP hospitals and community partners to offer DPP and DSMT directly in communities and will also increase the number of referrals into these programs.
Successful enrollment and completion of DPP has demonstrated reduced risk of developing type 2 diabetes for individuals with pre-diabetes. However, limited data exist on changes in body composition and liver fat in individuals completing DPP. Individuals with pre-diabetes often have obesity and non-alcoholic fatty liver disease. We will evaluate for changes in body fat and liver fat in individuals completing the DPP program.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Normoglycemia
20000 Participants Needed
Vivo for Prediabetes
Durham, North Carolina
This is a 12-week randomized, controlled trial that seeks to examine the effect of Vivo on 1) change in lower extremity strength defined as number of chair stands done in 30 seconds and 2) change in average glycemic level (HbA1c) compared to a wait list control.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60+
Key Eligibility Criteria
Disqualifiers:Unstable Angina, Arrhythmia, Uncontrolled Hypertension, Others
Must Not Be Taking:Antidiabetics, Testosterone
90 Participants Needed
Medically Tailored Meals + Lifestyle Intervention for HIV and Type 2 Diabetes
Chapel Hill, North Carolina
This is a single-site, open-label, Phase II, community-based randomized controlled explanatory trial to test the efficacy of a medically tailored meal + intensive lifestyle intervention (MTM + ILI) intervention for adults with food insecurity, HIV, and T2DM or high risk of T2DM, compared with a group that receives usual MTM.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:AIDS, Pregnancy, Cancer, Others
Must Not Be Taking:Glucocorticoids
200 Participants Needed
Nutrition and Exercise Education for Heart Disease
Chapel Hill, North Carolina
This study will test whether a culturally-tailored nutrition and exercise intervention designed for African-American women will lead to sustained improvements in exercise and healthy eating through improvements in self-management mediators: mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
174 Participants Needed
Exercise Training for Aging
Durham, North Carolina
The primary purpose of this study is to assess the effects of aging on markers of physical reserve and exercise-induced adaptations in resilience in older adults who completed a structured exercise program within the last 15 years (Parent trial: STRRIDE-PD; NCT00962962). This feasibility pilot study will enroll up to 8 participants to complete a 6-month aerobic exercise intervention.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:60 - 90
Key Eligibility Criteria
Disqualifiers:Tobacco Use, Insulin-dependent Diabetes, Cardiovascular Disease, Others
Must Be Taking:Cardiometabolic Medications
8 Participants Needed
Zinc for Prediabetes
Lancaster, Pennsylvania
The purpose of this investigation is to evaluate the impact of zinc supplementation on fasting glucose levels, hemoglobin A1c (HbA1c), and other indices of glucose homeostasis in individuals with prediabetes. The investigators hypothesize that prediabetic subjects receiving zinc will demonstrate a greater decrease in HbA1c and blood glucose compared to prediabetic subjects receiving placebo.
Specific Aim: Conduct a prospective, double-blind randomized clinical trial comparing the effects of 12 months of zinc supplementation (zinc gluconate 30 milligram \[mg\] per day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, the investigators will study 200 prediabetic subjects (100 per group) using a 1:1 randomization design. HbA1c, fasting plasma glucose, and other measures will be obtained at 0, 6, and 12 months and will be compared between zinc supplementation and placebo groups.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Pregnant, Cancer, Liver Disease, Others
Must Not Be Taking:Corticosteroids, Antipsychotics, Protease Inhibitors, Others
200 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
SWITCH App for Obesity
Columbia, South Carolina
The goal of the Self-monitoring With Internet Technology to Choose Healthy Diets (SWITCH) study is to examine a 12-week remotely delivered program designed to help adults adopt a healthy dietary lifestyle and lose weight in a diverse cohort of adults with overweight/obesity.
The intervention uses a self-determination theory framework to provide a deeper understanding of the factors that influence dietary behavior within the context of tracking. This study incorporates autonomy-supportive strategies to encourage participants to feel more in control of their dietary choices and will provide information and resources to boost participant's competence in achieving their dietary goals. The intervention includes weekly learning modules to support healthy eating and weight loss and daily dietary tracking with visual feedback, all accessible within the SWITCH app.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
106 Participants Needed
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Frequently Asked Questions
How much do Pre 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 Pre 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 Pre 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 Pre 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 Pre 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 Pre Diabetes clinical trials?
Most recently, we added Exendin 9-39 for Prediabetes, Meal Replacements for Weight Loss and Diabetes and Milk for Diabetes Prevention to the Power online platform.
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