Diabetes Paid Clinical Trials in California

The main purpose of this study is to assess the safety and efficacy of orforglipron compared with dapagliflozin in improving blood sugar control in participants with type 2 diabetes (T2D) with inadequate glycemic control using metformin. The study will last approximately 46 weeks. Read Less

The purpose of this study to compare the typically prescribed dose of metformin (1000mg twice a day) with a higher dose of metformin (1350mg twice a day). Read Less

The study is a two-arm, multicenter, double-blinded clinical trial testing sequential therapy with rituximab-pvvr followed by abatacept versus rituximab-pvvr alone in new onset T1D. The primary objective is to test whether the C-peptide response to a 2-hour mixed meal tolerance test, will be improved in participants with new onset T1D who are treated with Abatacept after Rituximab-pvvr compared to those treated with Rituximab-pvvr and placebo 24 months after enrollment. Read Less

The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits. Read Less

The purpose of this project is to develop and test the acceptance and clinical efficacy of a cognitive behavioral therapy (CBT)-based lifestyle intervention, to help manage obesity and diabetes-related health outcomes, provided through community health workers (CHWs) in Latino adults with type 2 diabetes (T2D). A collaboration with an established community-based organization named Sansum Diabetes Research Institute (SDRI), will provide an opportunity to develop, train and implement a culturally sensitive curricula for the CHWs that focuses on body weight and mental health (depressive symptoms and stress) among participants disproportionately impacted by T2D due to social, economic and community factors. Cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. Therefore, for our curricula to be culturally sensitive it will include the following aspects: being primarily delivered in the Spanish language with English as needed, actively incorporate culturally relevant eating and physical activity recommendations, and encompass the foundational importance of familial and social relationships as part of the mental health component of the intervention. For this proposal, the specific aims of this project are: 1) develop a CBT-based lifestyle intervention that focuses on diet, activity, depressive symptoms, stress, and quality of life in collaboration with CHWs and participants from SDRI, and provide training for three CHWs to implement this intervention; 2) conduct a 26-week randomized controlled trial in 50 Latino adults with T2D in the SDRI organization to evaluate the efficacy of the CBT-based lifestyle intervention to improve weight- and diabetes- related health outcomes (body weight, glycemic control, blood pressure, lipid profile, depressive symptoms, stress, and quality of life); 3) evaluate the acceptance and delivery of the CBT-based lifestyle intervention in CHWs and participants with T2D. If successful, this study will establish the structure and content of a culturally sensitive, effective CBT-lifestyle, community-based treatment. Read Less

Obesity affects over one third of US adults (>72 million, with BMI ≥30 kg/m2), and the proportion of US adults with BMI ≥40 kg/m2 has doubled in the last 20 years. Obesity is associated with increased mortality through its linkage to comorbidities including diabetes, hypertension, dyslipidemia, osteoarthritis, sleep apnea and psychosocial disturbances. Given its prevalence, impact on morbidity and mortality, and economic cost, limiting the spread of obesity and its consequences is one of the most important problems of our time. In this proposed study, investigators will recruit participants from a wide range of body mass index (BMI), ethnicity and Diabetes risk to collect data and blood, stool and adipose tissue samples in the San Francisco bay area. Read Less

With this study the investigators want to understand the physiological differences for people developing pre-diabetes and diabetes. The investigators hypothesize that different individuals go through different paths in the development of the disease. By understanding the personal mechanism for developing disease, the investigators will find a personalized approach to prevent that development. The investigators are also hoping to be able to find a biomarker that will pinpoint to the particular defect and thus, diagnose the problem at an earlier stage and have the information to give personalized diet recommendations to prevent the development of diabetes more effectively. Read Less

Diabetic peripheral neuropathy is one of the most common and costly microvascular complications of diabetes impacting more than 50% of patients and costing more than 10.1 billion dollars annually. Intraneural Facilitation Therapy (INF® Therapy) is a non-invasive technique that has shown to improve balance and pain in patients with Type 2 Diabetic Peripheral Neuropathy (T2DPN); however, the underlying physiological mechanisms need further understanding. The purpose of this study is to investigate the physiological mechanisms behind two approaches to treating T2DPN, INF® Therapy and standard physical therapy. Eligible subjects presenting with diabetic neuropathy symptoms will be recruited and referred to the Loma Linda University Health's Neuropathic Therapy Center. Forty patients will be evenly randomized into two groups: an INF® Therapy Treatment group and standard physical therapy treatment group. Subjects will participate in 11 study visits over a period of 6 weeks. Non-invasive assessments will measure neuropathy pain, heart rate variability, neuropathy severity, blood oxygen levels, and blood flow under the skin. Lab draws will measure inflammation levels in the blood and how well blood sugar levels have been maintained over a period of about 3 months. Descriptive statistics and repeated measures ANOVA will be used to analyze data and answer the research questions. The findings of this study will provide a better understanding of how INF® Therapy and standard physical therapy work, subsequently improving non-invasive treatment methods for T2DPN patients. Read Less

This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants. Read Less

This is a Phase 4 study with 2 parts: Part 1 (Prevalence Phase) is non-interventional and will assess the prevalence of hypercortisolism in a population with difficult to control type 2 diabetes (T2D) (hemoglobin A1c ≥7.5%) despite receiving standard-of-care therapies. Part 2 (Treatment Phase) is a randomized, prospective, placebo-controlled, double-blind multi-center trial that will assess the safety and efficacy of mifepristone treatment in patients with hypercortisolism who have difficult to control T2D despite receiving standard of care therapies. Read Less

This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment. Read Less

The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting. The combined run-in period and study period will be approximately 135 days long. Read Less