303 Clinical Trials for Diabetes Mellitus, Type 2
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.
Study Overview: This interventional study aims to assess whether training healthcare professionals (HCPs) increases the number of continuous glucose monitor (CGM) prescriptions for patients with Type 2 Diabetes in a Federally Qualified Health Center serving a predominantly Hispanic/Latino population. Research Questions: Does HCP training enhance CGM prescription rates in a primary care setting? Does receiving a CGM prescription lead to improved Type 2 Diabetes control, as measured by Hemoglobin A1c levels? What barriers do patients face when prescribed and using CGMs? Given the significant impact of CGMs on diabetes management, this project seeks to improve CGM utilization among eligible patients through a focused intervention for HCPs and evaluate diabetes outcomes for those who do and do not receive a CGM. Methodology: HCPs and staff from three clinics within the same healthcare system will undergo a brief, in-person training on current clinical guidelines and insurance eligibility for CGMs. A booster session will follow about one month later to reinforce learning and address any prescribing challenges. Training efficacy will be evaluated by comparing CGM prescription rates before and after training using electronic health records. HCPs will complete pre- and post-training surveys to assess changes in knowledge, beliefs, and prescribing practices related to CGMs. Additionally, a small subset of prescribers will participate in interviews about their experiences with CGM prescriptions four months post-training. Patient Recruitment and Surveys: Patients with Type 2 Diabetes will be recruited for surveys at baseline, and at 3 and 6 months. These surveys will gather information on their diabetes management experience, levels of diabetes distress, and whether CGM discussions occurred with their primary care provider. Participants who received CGM prescriptions will share their experiences and any barriers encountered. A subset will also be invited for interviews to further explore their CGM experiences. Conclusion: This study seeks to fill a crucial gap in understanding how HCP training influences CGM prescription rates and the associated diabetes management outcomes, ultimately aiming to enhance diabetes care for a vulnerable population.
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).
The purpose of this study is to learn about the interactions of markers of type 2 diabetes (T2DM) and periodontitis (PD). Study VPE00001 is a multi-center cross-sectional study. Participants will be categorized based on point-of-care hemoglobin A1c (HbA1c) and periodontal disease (PD) staging into 9 subgroups. The key objectives of the study are: * To evaluate immune signatures in well-characterized populations with or without PD and/or T2DM * To evaluate baseline clinical biomarkers of T2DM and PD in well-characterized populations * To evaluate the influence of clinical, immunological, and microbiological biomarkers on the bidirectional relationship between T2DM and PD
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2 Diabetes Mellitus (T2DM). The primary objectives of this study are: * To characterize the pharmacokinetics (PK) of GS-4571 following single and multiple ascending oral doses of GS-4571. * To evaluate the effect of concomitant food intake and (if conducted) a representative acid-reducing agent (proton pump inhibitor (PPI), omeprazole) on the PK of GS-4571. * To evaluate the safety and tolerability of single and multiple ascending oral doses of GS-4571.
A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR; Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis. Subjects should have Type 2 Diabetes Mellitus (T2DM) with HbA1C ≤9 that is managed without insulin and have been diagnosed with symptomatic unilateral or bilateral osteoarthritis (OA) of the knee, based on clinical and radiological criteria (if bilateral, then a target knee will be selected).Total study duration for individual subject will be about 4 months, which includes 3 weeks of Screening period, 10 days of pretreatment phase, treatment day, and 12 weeks of post-treatment period.
Nutrition guidelines state that multiple eating patterns are effective for type 2 diabetes and that therapy should be individualized. Yet many nutrition plans fail to account for interpersonal variability in blood glucose response to meals. This diminishes the ability of dietary interventions to optimize glycemic control and may lessen patient satisfaction, self--efficacy, and adherence. Continuous glucose monitoring (CGM) can facilitate behavior change in type 2 diabetes and has been associated with improved outcomes in nutrition intervention studies; this literature is limited by small study sample sizes and heterogeneity of study design and outcomes, and more data are needed. CGM could be a powerful tool for adapting a nutrition plan based on blood glucose response at an individual level. This study will test the use of CGM to personalize nutrition therapy compared to nutrition therapy alone (without CGM) for participants with type 2 diabetes who are not meeting glycemic treatment goals.
This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior).
The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.
This study is designed to evaluate the safety and effectiveness of endoscopic intestinal re-cellularization therapy in individuals with type 2 diabetes (T2D) inadequately controlled on non-insulin glucose-lowering medications.
Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are: 1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals. 2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.
The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control. The main question\[s\] it aims to answer are: * To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control. * Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport Participants will have: * A screening visit * placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0 * Additional visits/phone calls for intensification of diabetes management and nutrition visits * Second magnetic resonance spectroscopy (MRS) at week 12
The overarching goal of this study is to understand facilitators and barriers to self-care, develop and refine a culturally tailored intervention to improve clinical outcomes, quality of life (QOL), and self-care behaviors in African American adults with diabetic kidney disease (DKD) experiencing multidimensional adversity (MDA) and living in the inner-city.
The design of the Phase 2 clinical trial includes the following elements: * Multi-center, two-arm, randomized, double-blind, placebo-controlled trial to evaluate MN-001 (tipelukast) vs. placebo in approximately 40 patients in the U.S. * Patients will be randomized 1:1 to receive either 500 mg/day of MN-001 (tipelukast) or placebo for 24 weeks. * The co-primary endpoints are (1) change from baseline in liver fat content measured by controlled attenuation parameter (CAP) score at Week 24, and (2) change from baseline in fasting serum triglycerides at Week 24. FibroScan® is a non-invasive, quantitative, and accurate measure of liver fat content commonly used in early phase trials to measure treatment response. * Secondary endpoints include safety and tolerability and changes in lipid profile (HDL-C, LDL-C, and total cholesterol).
This is a randomized clinical trial to assess the feasibility and efficacy of time-restricted eating (TRE) to improve glucose regulation and cardiovascular health of participants with type 2 diabetes mellitus (T2DM). Participants will be randomized into 2 groups: 1) standard of care (SOC), in which they will continue to follow their physician's treatment plan, or 2) SOC and TRE (8-10 hours eating window).
Rady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Adolescents and young adults with youth-onset type 2 diabetes (T2D) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (T1D). In fact, 50% of males with youth-onset T2D have serum uric acid (SUA) greater than 6.8 mg/dl. The investigators also recently demonstrated that higher SUA conferred greater odds of developing hypertension and diabetic kidney disease (DKD) in youth with T2D over 7 years follow-up. Elevated SUA is thought to lead to cardiovascular disease (CVD) and DKD by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. While there are studies demonstrating beneficial effects of uric acid (UA) lowering on vascular health in the general population, there are no studies in youth-onset T2D. Youth-onset T2D carries a greater risk of DKD and CVD compared to adult-onset T2D and T1D. Accordingly, a clinical trial evaluating UA lowering therapies is needed in youth-onset T2D. Krystexxa (pegloticase), a uricase, effectively lowers SUA and therefore holds promise as a novel therapy to impede the development of CVD and DKD in youth-onset T2D. This proposal describes a pilot and feasibility trial evaluating the effect of UA lowering by pegloticase on markers of CVD and DKD in ten (n=10) youth aged 18-25 with youth-onset T2D (diagnosed \<21 years of age) over 7 days. The overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering UA.
The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is: Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible? Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes. Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.
The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge.
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).
The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.
The purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus.
While data from the National Health and Nutrition Examination Survey (NHANES) estimate that 36.9% of patients with diabetes have CKD, only approximately 10% of patients are aware of their kidney disease. In its 2020 Standards of Medical Care in Diabetes, the ADA recommends that all patients with type II diabetes (T2DM) undergo annual measurement of urine albumin-to-creatinine ratio (UACR). The National Kidney Foundation (NKF) has also proposed an update to the requirements for assessment of adults with diabetes including both an estimated glomerular filtration rate (eGFR) and uACR. The goal of accurately identifying patients with T2DM and CKD is to help providers intervene at an earlier stage of kidney impairment, improve renal outcomes, and reduce associated healthcare costs. Failure to adopt these guideline recommendations has widespread implications, including underestimation of the burden of CKD in the T2DM population, delays in diagnosis of renal impairment, and ultimately, underutilization of therapies that could improve clinical outcomes. This single-center, 400-patient, randomized controlled trial will assess the impact of an EPIC Best Practice Advisory (BPA; alert-based CDS tool) on guideline-directed assessment for CKD using UACR in patients with T2DM who have not had a UACR in the past year.
The rapid growth rate and unique challenges as a new immigrant group call for a better understanding of the social and health needs of the older Asian Americans (AAs) population. Overwhelming numbers of AAs, a fast-growing first-generation immigrant group, suffer from type 2 diabetes (T2D) and its consequences of poorly controlled blood glucose. For the older AAs, there are higher prevalence rates, worse diabetes control, and higher rates of complications due to limited English proficiency and health literacy. Despite the evidence concerning the effects of dietary interventions on glycemic control by well-controlled feeding studies in mainstream Americans, a lack of clinical trials of culturally tailored interventions often imposes serious barriers to translate and implement such fruitful and innovative approaches in individuals from ethnic minority communities such as AAs. The proposed study will use a randomized, controlled design with a sample of 60 AAs aged 65 years or older. Metabolomics methodologies will be incorporated into this research to provide a global picture of metabolites' responses to personalized behavioral nutrition (PBN) intervention. The study results will obtain the necessary information to conduct a meaningful community-based clinical trial to test the effectiveness of PBN in improving dietary patterns and glycemic control in older AAs.
The reason for this research study is to better understand the use of liraglutide, a commonly prescribed Type 2 diabetes medication, in patients with a diagnosis of maturity-onset diabetes of the young (MODY). The investigators are interested in better understanding the way that this drug affects the metabolism and hormone levels of a person with MODY. Many people with MODY report having gastrointestinal (GI) issues such as an upset stomach. Investigators also interested in finding out if this drug will help with GI issues. If liraglutide does help with this symptom of MODY, the investigators want to know why this happens. If this drug is effective for participants, the investigators will use participants cells to make human induced pluripotent stem cell (iPSC). This means that the investigators will use participant cells to create what are called stem cells, which are cells in the body that are able to be told what their job is. Investigators will use these cells to see what happens in gastrointestinal (GI) tract.
The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.
The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.