Active clinical trials for "Diabetes Mellitus, Type 2"

The overarching goal of this study is to decrease disparities and increase access to continuous glucose monitoring (CGM) for patients with diabetes, regardless of where people receive their diabetes care. This study aims to evaluate the effectiveness of three implementation strategies for CGM in primary care practices in an efficient, sustainable, and scalable fashion. The investigators will also perform economic analysis of the implementation strategies. This 3-year study will compare practices that implement CGM with (a) an evidence-based educational module only, (b) an educational module plus practice facilitation support, or (c) a virtual CGM initiation clinic for patients. There will be up to 30 practices in each group for a possible total of 90 primary care practices. The investigators expect to enroll up to 500 patient participants across these 90 practices and to compare outcomes among patients from each study arm. This comparison will help investigators to understand the different implementation strategies and their ability to help primary care practice adopt, implement, and maintain CGM for their patients. The information the investigators collect will also help to understand how patients in these primary care practices experience initiation and use of CGM. The results will help to develop strategies and tools to train more primary care practices to offer CGM more widely to patients for whom it is recommended, especially for those where access to specialty care is limited.

This RCT study will evaluate the effect of a lifestyle intervention on overweight or obese patients with type 2 diabetes mellitus. The primary hypothesis is that the mHealth-based intensive lifestyle intervention is sufficient to achieve weight loss and maintain glycated hemoglobin control.

Rationale: Diabetes mellitus is a chronic disease that is often associated with long-term macrovascular and microvascular complications and decreased life expectancy. Approximately 70% of patients with type 2 diabetes mellitus (DM2) are overweight or obese. Weight loss benefits several aspects of DM2, such as improved glycemic control, increased insulin sensitivity and reduced fasting insulin. This results in a reduction in glycated hemoglobin. Interventions for weight loss in patients with DM2 include diet, exercise, but also pharmacotherapy and bariatric surgery. Current standard pharmacotherapeutic treatment for patients with DM2 in the Netherlands starts with metformin, followed by insulin. Bariatric surgery is indicated at a BMI > 35 kg/m², in combination with other comorbidities. It is associated with better glycemic control and more weight reduction, compared to intensive medical treatment alone. For patients with not adequately controlled DM2 who are not eligible for surgery (i.e., BMI of < 35 kg/m²), there is currently a therapeutic gap, which could be filled by one of the currently available endoscopic therapies aiming to reduce weight. One of these therapies is endoscopic suture gastroplasty, performed with the endomina device (EndoTools Therapeutics S.A.). Objective: To evaluate the efficacy and safety of endoscopic sutured gastroplasty with the endomina device (EndoTools Therapeutics S.A.) for glycemic control, in obese patients (BMI of 30-40 kg/m²) with DM2 under insulin therapy with or without hypertension. Study design: Prospective interventional study Study population: All consecutive patients, with a BMI between 30 and 40 kg/m² with DM2 for less than 10 years, treated with insulin therapy. Intervention: Endoscopic suture gastroplasty will be performed using the endomina device. Main study parameters/endpoints: Reduction of 0.7% in HbA1C after 1 year post procedure. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will undergo endoscopic suture gastroplasty using endomina, which is known with only minor adverse events (abdominal cramps, nausea, vomiting), and a serious adverse events so far of > 1% (one readmission, no surgical intervention needed, no mortality). Afterwards, patients will be followed at 14 days, 1 month, and 3, 6, 9 and 12 months after gastroplasty for clinical and adverse event assessment. Clinical assessment consists of laboratory tests and the quality-of-life questionnaire (EQ-5D-5L), and Diabetes Treatment Satisfaction Questionnaire as well as Quality adjusted life years.

In Denmark the vast majority of patients with chronic ischemic heart disease and/or type 2 diabetes are managed in general practice. 20% of the patients suffer from poor mental health. Problem-solving therapy (PST) is a psychotherapeutic method that is proven effective in adults with poor mental health. PST can be provided in general practice. The main objective of this study is to test effectiveness of providing PST to this group patients.

The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.

The purpose of this study protocol is to assess the effect of concurrent aerobic and resistance training and vitamin D supplementation on lipid profile in patients with type 2 diabetes.

Management of type 2 diabetes mellitus (T2DM) has evolved from a glucocentric to a cardiometabolic approach. Both glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2is) reduce cardiovascular and kidney outcomes in T2DM patients with a low hypoglycemia risk. The T2DM di per se still carries a higher risk of mortality and major cardiovascular complications, doubling the case fatality rate. Tacking that GLP-1RAs and SGLT2is have different mechanisms of action, resulting in complementary pharmacokinetics and pharmacodynamics, the combination use may present clinical efficacy and safety in T2DM patients with AMI. However, there is limited clinical evidence that supports the combined use of these drugs, and there are currently no studies investigating the effects of combination treatment in T2DM patients with acute cardiovascular events, on MACE as well as on myocardial post-infarction rescue. Therefore, authors will conduct an observational prospective study to evaluate the effects GLP-1RAs and SGLT2is combination therapy on MACE such as mortality, acute coronary syndrome and heart failure, and myocardial salvage index (MSI) after acute myocardial infarction (AMI) in T2DM patients.

Diabetes can lead to heart failure independently, but the underlying causes remain incompletely understood. The main aim of this study is to identify differential regulation of mitochondrial substrate utilization and complex activity in heart failure and type 2 diabetes mellitus (T2DM). For this, we will conduct a prospective, observational study to examine myocardial mitochondrial oxidative function and related metabolic parameters, gene expression, histological markers, and inflammation in cardiac tissue from patients with heart failure or patients after heart transplantation. We will further assess cardiac function using cardiac magnetic resonance imaging with and without stress protocols and magnetic resonance spectroscopy. Glycemic control/T2DM will be characterized by oral glucose tolerance tests. The results of this project will help to better understand the cellular mechanisms of the development of diabetic cardiomyopathy and contribute to the development of early diagnostic, as well as therapeutic approaches for the prevention and treatment of diabetic cardiomyopathy.

There is a close association between overweight, abdominal type, and type 2 diabetes mellitus (T2DM).The scientific literature of recent years shows the existing relationship between weight loss, of 15% or more of body weight, and the positive effect on body composition parameters as well as on glycemic profiles. Specifically, here the investigator focuses on very low carbohydrate ketogenic diets (VLCKDs) as a nutritional strategy for managing excess weight and improving diabetes. Current knowledge is changing the face of T2DM, showing that an effective, appropriate and early intervention can lead to a remission of diabetes involving a partial recovery of insulin secretion as well as its action. Nevertheless, the daily life of the diabetic patient followed in an office can be less linear than that of a patient participating in a study protocol, with planned follow-up visits and close supervision. What about the impact of VLCKD, observed in clinical studies, in patients with T2DM in real-life? In order to answer this question, we would like to analyze here a series of patient files with T2DM and overweight, followed in a private practice, specializing in diabetology, who have adhered to a VLCKD, by a commercial method (PnK® Method), in order to improve their glycemic control.

The purpose of this study is to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.