Diabetes Clinical Trials in Houston, TX

The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes). Read Less

Hispanic adolescents in the U.S. are disproportionately burdened by type 2 diabetes (T2D) compared to non-Hispanic white youth (0.079% vs. 0.017%) contributing to higher rates of T2D-related vascular complications, cardiovascular disease, and mortality, among this population. Disparities in T2D are driven in part by independent, modifiable risk factors including low levels of physical activity, sleep, and poor diet. Lifestyle interventions are the cornerstone for maintaining glucose control and managing T2D. However, few studies have developed and tested lifestyle interventions for Hispanic youth with T2D. Digital health interventions that promote healthy lifestyle behaviors like physical activity, sleep, and diet, have demonstrated effectiveness among adults. Studies that use health-based smartphone applications have demonstrated preliminary efficacy for improving health-related lifestyle behaviors as these digital tools leverage behavior change techniques (e.g. self-monitoring, goal-setting, feedback) that have proven effective. Use of digital technology allows for the continuous delivery of intervention content into the home environment extending the reach of clinical care while engaging youth in a format that is age-appropriate given that today's youth are digital frontrunners. Unfortunately, while the use of digital health interventions have increased, few studies have focused on adolescents with overweight and obesity who are at high risk for T2D. The purpose of this study is to 1) develop a mobile health platform for remote and continuous monitoring of activity, sleep, and nutrition and 2) conduct a pilot study (30 days) to evaluate the efficacy of a novel digital health platform in improving obesity-related health outcomes outcomes in Hispanic adolescents (12-18 years; N=30) population. Read Less

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 Read Less

The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day. Read Less

Non-healthy eating habits and a lack of exercise contribute to prediabetes and type 2 diabetes (T2D). Evening snacking is linked to abnormal weight gain in adults and healthy adolescents. Most adolescents do not get enough exercise. This study aims to look at the benefits of more exercise and stopping evening snacking in youth with prediabetes. The study lasts 8 weeks, and participants will be randomly assigned to either an intervention group or a standard of care group. Read Less

The goal of the DISCOVERY study is to provide innovative critical information regarding the unique natural history of glycemic control, insulin sensitivity, and β-cell function, and their mechanistic determinates, in obese adolescents at risk for developing type 2 diabetes. Read Less

Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents. Telehealth is a potentially effective approach for delivering disease prevention programs as it addresses some SDoH like transportation, childcare needs, and parent work schedules. Unfortunately, there are no theory- or evidence-based telehealth diabetes prevention program for Hispanic adolescents. Therefore the purpose of this study is to adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity. Read Less

The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact. Read Less

In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to increase diabetic retinopathy screening rates to 70.3%. Research indicates that low screening rates are associated with a variety of factors, including income levels, race and lack of access to care. Furthermore, because diabetic retinopathy frequently presents asymptomatically, non-adherence to screening results in postponed disease detection and a higher probability of vision loss. Currently, it is estimated that 9 million adults in the US are affected by diabetic retinopathy, and 1.8 million suffer from vision-threatening diabetic retinopathy. Importantly, the rates of vtDR vary greatly by race, with Hispanic individuals at 7.14% and Black individuals at 8.66%, compared to 3.55% in White individuals. Despite these alarming figures, the disease can be managed and vision loss can often be averted with early disease detection, thus highlighting the importance of increasing screening rates. A clear need exists for a diabetic retinopathy screening tool that can be deployed in primary care settings, addressing the shortage of specialist care and making screening more accessible to underserved populations. OPTDR01 will directly address these issues by providing accessible, high quality screening for diabetic retinopathy. OPTDR01 will automatically detect more than mild diabetic retinopathy (mtmDR) and vision-threatening diabetic retinopathy (vtDR) in diabetic adults who have not previously been diagnosed with mtmDR or vtDR. Read Less

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Similar to all studies that will be coordinated and managed by the CDMC, no patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC, which are listed in the appended DETECT protocol. The data management systems, auditing, and monitoring effort are supported by the CDMC. Read Less

To elucidate the mechanisms by which type 1 diabetes-associated genes; IFIH1, TYK2, IKZF4, as well as total genetic risk, impart functional immunoregulatory abnormalities that result in expansion of self-reactive adaptive immune cells, defective regulatory/effector mechanisms in T cells, inflammatory antigen presenting cells, and abnormal immune function in T cells and B cells. Read Less

Type 2 diabetes (T2D), once considered only "a disease of older ages," is now a significant public health concern in youth. Although it is characterized by insulin resistance and impaired insulin secretion, its precise etiology and pathogenesis are not yet fully understood. This study aims to (1) explore arginine metabolism in youth with T2D via safe, minimally invasive kinetic experiments using stable isotope tracers and targeted metabolomics, and (2) determine the effect of exogenous arginine administration on β-cell function in youth with T2D, potentially supporting the use of this safe, low-cost, and readily available nutrient to improve pediatric diabetes outcomes. Read Less