View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:This implementation study aims to identify priorities and formulate strategies to overcome health service delivery bottlenecks associated with hypertension and diabetes in rural China. Leveraging implementation frameworks, the study seeks to unravel the complexities embedded within the care cascade, paving the way for targeted interventions. Addressing the nuanced dynamics of the care cascade, this research will provide indispensable insights for optimising healthcare delivery in resource-limited settings, ultimately informing global perspectives on chronic disease management. The overall aim of this study is to enhance the control of hypertension and diabetes in rural China through a systematic assessment and improvement of the care cascade, specifically: 1. To describe the cascade gap and identify barriers and facilitators at each cascade stage. 2. To develop practical interventions through stakeholder co-design. 3. To assess the effectiveness of developed interventions and evaluate implementation strategies.
Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.
The goal of this clinical trial is to investigate efficacy and safety of an herbal medicinal product of (NW Low-Glu®) in patients with Type 2 Diabetes Mellitus (T2DM). The main question[s] it aims to answer are: • What will be the mean change in HbA1c levels in the experimental arm (NW Low-Glu®) compared to the active-control arm (metformin) after 6 months of treatment? Participants will randomized in a 1:1 allocation ratio, into one of the two treatment groups, to receive either Metformin or NW Low-Glu®. Researchers will compare the mean change in HbA1C, fasting blood glucose, and weight between the experimental arm and the active-control arm.
Endoscopic bariatric and metabolic therapies (EBMT) are a non-invasive, safe alternative treatment for patients with obesity. Current FDA- approved devices include intragastric balloons (IGB) and suturing devices for endoscopic sleeve gastroplasty (ESG). These gastric interventions work by interfering with how the stomach expands to accept and process a meal, which slows down how fast the stomach empties. ESG, the procedure the investigators are doing in this study, involves endoscopic suturing to reduce the length and width of the stomach so that the patient feels full faster. Semaglutide is a popular medication for weight loss, and has shown significant weight loss with a good safety profile in clinical trials. In this study, the investigators will compare ESG, Semaglutide only, and an ESG + Semaglutide combination, on weight loss for subjects undergoing the procedure with a history of obesity, liver fibrosis and NAFLD. To better understand how these impact obesity and liver fibrosis, the investigators will track weight loss, laboratory values, liver stiffness, and the patients overall liver health. The suturing device used in the ESG procedure and the semaglutide are all approved by the U.S. Food and Drug Administration (FDA) for endoscopic procedures in the upper gastrointestinal tract and medication management of obesity. This is a study that will randomize patients to 1 of 3 different treatment options: ESG only, Semaglutide only or ESG + Semaglutide. The investigators want to see if adding the weight loss medication to the ESG procedure will increase weight loss and how it will impact liver health.
Individuals of Chinese heritage are the largest and fastest growing segment of the US Asian population. US Chinese have sociodemographic characteristics and culture that differ substantially from other US Asians, and therefore, differ in social determinants of health, health status, and disease risk. US Chinese adults are at increased risk for cardiometabolic disease, related conditions (obesity, type 2 diabetes mellitus, hypertension), and systemic inflammation that promotes disease onset and progression. Immigration to a new country can substantially impact the gut microbiome which may promote systemic inflammation. Pilot interventions indicate a high-fiber diet rich in whole grains reduced inflammation and improved obesity. Additionally, the United States Department of Agriculture (USDA) supported, evidence-based HomeStyles intervention has demonstrated feasibility, acceptability, and efficacy in improving lifestyle behaviors and home environments associated with obesity risk in families. A lack of linguistically, culturally tailored interventions to their specific health needs makes it difficult for US Chinese to implement healthy lifestyle behaviors and reduce health risks. Interventions tailored for US Chinese that could attenuate modifiable cardiometabolic risk factors, understand physiological sequelae, and bridge health equity are not currently available. Thus, the overall goal of this project is to test the efficacy of HomeStyles in improving health outcomes in US Chinese. Project aims are to: A) Culturally adapt the HomeStyles intervention through community-engaged approaches. B) Conduct a 10-week, 2-armed Randomized Controlled Trial (RCT) to test HomeStyles intervention efficacy on health outcomes (dietary intake, physical activity, self-efficacy, HbA1C, waist circumference, and BMI), hypothesizing that participants randomized to the treatment condition will have greater improvements in health outcomes than control comparators. C) Examine associations between intervention participation and gut microbiota/systemic inflammation and test hypotheses that a whole-grain rich diet adopted by those in the intervention group will increase anti-inflammatory gut bacteria, reduce inflammatory gut bacteria, and lower systemic inflammation.
Many investigations have been done to determine the exercise that can elicit the greatest benefits on glycemic control and metabolic health, with findings suggesting that incorporation of higher intensity and longer duration of exercise prescribed may eliminate much of the "non-response" observed following exercise training. Even with the incorporation of higher intensity exercise into interventions aimed at improving glycemic control in individuals with type 2 diabetes mellitus (T2DM), the investigators and others continue to have mixed results, with not all individuals with T2DM obtaining benefits in insulin sensitivity and glycemic control to a given exercise training program. Many of the metabolic processes involved in glucose homeostasis, such as insulin production and sensitivity, undergo daily circadian rhythms, controlled by cellular clock machinery located both centrally and peripherally (i.e. skeletal muscle). However, in adults with T2DM, these diurnal rhythms are impaired, with reduced insulin sensitivity in the morning, which is thought to contribute to the fasting hyperglycemia (i.e., "dawn phenomenon") observed in these individuals. Exercise may be a non-photic cue that can amplify or alter these metabolic rhythms. It has been suggested that skeletal muscle metabolic inflexibility in metabolic disorders such as overweight/obesity and T2DM is associated with reduced mitochondrial fatty acid oxidative capacity. It has been demonstrated that exercise can increase mitochondrial oxidative capacity by remodeling mitochondrial morphology and dynamics. It is unknown if potential differences in metabolic flexibility can be found in response to exercise at different times of the day. Most of the experimental evidence originates from animal models with only 3 studies performed in humans with T2DM, which displayed conflicting results. To overcome the shortcomings in the literature, the main objective of this research project is to assess the effects of performing exercise at different times of the day on glycemic control and related outcomes on the inter-individual response variability in glycemic control and related metabolic health parameters in two distinct populations: 1) individuals with T2DM on the most common mono-hyperglycemic drug therapy (i.e., metformin); and 2) age-matched sedentary overweight/obese individuals, where glycemic control is known to deteriorate, hence increasing the risk of developing insulin resistance and T2DM.
The present study aimed to assess the effect of non-surgical periodontal treatment on serum and salivary chemerin, fetuin-A, IL-34 and IL-13 levels in periodontitis with and without diabetes mellitus (DM) type 2. 22 non-periodontitis, 22 non-periodontitis with DM, 22 Stage III/IV Grade C periodontitis, 22 tage III/IV Grade C periodontitis with well-controlled DM and 22 tage III/IV Grade C periodontitis with poorly-controlled DM patients were enrolled. At baseline, serum and saliva samples were collected, and the whole mouth clinical periodontal parameters were recorded from all subjects. Periodontitis patients received non-surgical periodontal therapy. Clinical parameters were re-measured, and samples were re-collected 1 and 3 months after therapy from periodontitis patients. Serum and salivary protein levels were analyzed by ELISA. Data were analyzed using appropriate statistical tests.
This feasibility study will evaluate the feasibility of two telemonitoring designs for non-insulin treated T2D patients with an eye to identify the most suitable telemonitoring intervention for a future large-scale randomized trial.
Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those who are on GLP1-RAs vs those where GLP1-RAs are discontinued. Understanding the role these medications play in not only clinical outcomes after metabolic surgery but potential metabolic mechanisms by which surgery improves patient's metabolic health could help people with obesity and type 2 diabetes make informed decisions about their treatment options as well as advise providers on the continuation of these medications in the perioperative and postoperative period.
The aim of the study is to evaluate the efficacy of the co-created, culture-sensitive intervention to promote healthy diet, physical activity, and to improve compliance to therapeutic protocols in immigrants with type 2 diabetes.