Active clinical trials for "Diabetes Mellitus, Type 2"

The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.

The primary aim of this study was to evaluate the difference in cognitive function and brain functional structure between exercise group and control group by performing regular one-year moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive function. The secondary aim of this study was to explore the effects of six-month regular moderate-intensity aerobic training on pancreatic fat content, metabolic index of glucose and lipid, as well as cardiovascular risks in patients type 2 diabetes mellitus.

The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on acute postprandial glucose regulation of plant based lipids. Due to the tight connection between cardiometabolic health and cognitive functions, a secondary issue is to investigate effects of test foods on cognitive test variables and mood parameters.

The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.

Background Paleolithic diet is a modern dietary regimen based on food eaten during the Paleolithic (2.5 million-10.000 years before present); lean meats, fish, shellfish, fruits, vegetables, root vegetables, eggs and nuts. Food that was not eaten during the Paleolithic is avoided; cereals, dairy products, salt, refined sugar and fat. The rationale for Paleolithic diet is based on the lack of type 2 diabetes and associated diseases among hunter-gatherer populations. Our group have previously studied effects of Paleolithic diet in an observational study in humans, an intervention study in animals and two intervention studies in patients with type 2 diabetes or lowered glucose tolerance and ischaemic heart disease. Our intervention studies showed significant improvement of glucose tolerance, HbA1c, blood lipids, blood pressure, weight, waist circumference and satiety on Paleolithic diet compared with a Mediterranean-type diet and diabetes diet. Studies by other research groups on healthy individuals found that Paleolithic diet lowered weight, waist circumference, blood pressure, PAI-1, blood lipids and ectopic lipid deposition, and also improved glucose tolerance and insulin sensitivity. Purpose and aims Our goal is to study effects of Paleolithic diet compared to recommended diet on risk factors, morbidity and mortality from type 2 diabetes and associated diseases in a sufficiently large and well executed study to be included in basis for future dietary recommendations. Project descriptions SwePaD is a study with an initial 18 month long randomized cross-over dietary intervention on 150 patients with type 2 diabetes where the whole study population upon finishing the initial dietary intervention is studied as a cohort for another 5 years. The initial 18 month long dietary intervention compares 6 months on Paleolithic diet with 6 months on recommended diabetes diet separated by 6 months wash-out period. After the initial 18 month long dietary intervention the study participants are recommended to follow recommended diabetes diet with implementation of optional elements from a Paleolithic diet for the remaining 5 years of the study. The intervention, in the form of diet information, will be given orally and written by the study participant's own diabetes nurse or doctor, based on similarly designed written information on the two diets. The same intervention was successfully used in our pilot study. The study participants will otherwise receive usual treatment. Power calculations show that 126 participants are needed to obtain significant results with 80% power at the 95% significance level for the primary outcome HbA1c. The pilot study with the same intervention but slightly healthier participants than the average patient in Diabetesregistret showed significant results on HbA1C with only 13 participants. Secondary outcomes are fasting glucose levels, weight, waist circumference, blood pressure, blood lipids, urinary albumin, diabetes retinopathy, smoking, physical activity, monofilaments (detection of peripheral neuropathy) and health related quality of life assessed by the health survey questionnaire SF-36. Primary and secondary outcomes as well as medication will be registered before and after each intervention diet. Data on primary and secondary outcomes, morbidity and mortality from type 2 diabetes and associated diseases will be retrieved for up to five years after participants' completion of the dietary intervention from the Diabetes register, Cause of Death Register (Dödsorsaksregistret) and the Hospital Discharge Register (Patientregistret) and compared to expected outcome from a statistical model based on the Diabetes register (A new model for 5-year risk of cardiovascular disease Cederholm et al 2011) and/or a matched control group from the Diabetes register. Participants will be recruited nationwide through information to health care personnel in primary health care and hospital diabetes clinics and to patient organisations. Participants' registration, intervention and data gathering will be administered by the participants' own diabetes nurse or doctor via REDCap, a web based tool for secure electronic data capture hosted on secure servers with daily back-up by the Library and IKT department of the medical faculty at Lund University. Dietary evaluation will be made using four day weighed food records on paperforms before and after each intervention diet and 6 months after the last intervention.

Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest that beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population. However, no results from large-scale clinical outcome trials with beta-blockers exist in this patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be justified due to potential harmful side-effects such as AV-block or hypotension. In addition, we are lacking identified ECG surrogate parameters for SCD in this high-risk population and on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions. Therefore, the present study will identify surrogate parameters of SCD in hemodialysis patients with T2DM and in an interventional trial investigate the suppressive effect of beta-blockers on these identified ECG markers.

The aim of this study is to determine whether vitamin D supplementation in overweight/obese individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance by decreasing subclinical inflammation. Results of the present study may help to identify new strategies to prevent type 2 diabetes in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong family history of diabetes). Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical chronic inflammation. Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals with low vitamin D levels will: improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function determine whether this relationship is mediated by a reduced chronic inflammation

This study will evaluate the immunogenicity and safety of Engerix™-B (hepatitis B vaccine) when administered as a primary vaccination course at 0, 1 and 6 months in adults with or without type 2 diabetes mellitus.

The purpose of this randomized trial is to study the efficacy of a novel social propagation intervention which integrates social network induction with health education for weight and metabolic control among patients with type 2 diabetes, BMI of 25-30+, and cardiovascular disease. The intervention takes place in the form of a community health program, where participants who enroll in this program will be asked if they would like to take part in the study to evaluate its efficacy. Thus, the investigators will study the efficacy of social networks in propagating changes in lifestyle factors for diabetes and chronic disease management

Objective: To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients. To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM. Methodology: Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.