Active clinical trials for "Diabetes Mellitus, Type 2"

Diabetes type two is a debilitating disease that leads to chronic morbidity such as accelerated microvascular disease. Accelerated microvascular disease may produce blindness, end stage renal disease, myocardial infarction, stroke, and limb ischemia. Strategies to prevent or delay microvascular disease have the potential to improve the lives of millions and prevent catastrophic illness. The major focus of prevention of microvascular disease in diabetes has been on the endothelium and its role in protection of blood vessels. An unexpected means to prevent microvascular disease in diabetes may be coupled to the function of vitamin C in red blood cells (RBCs) of diabetic subjects. Based on new and emerging data, vitamin C concentrations in RBCs may be inversely related to glucose concentrations found in diabetes. Based on animal data, we hypothesize that RBCs with low vitamin C levels may have decreased deformability, leading to slower flow in capillaries and microvascular hypoxia, the hallmark of diabetic microangiopathy. Low vitamin C concentrations in RBCs of diabetic subjects may be able to be increased, by using vitamin C supplements. Findings in animals may not accurately reflect effects in humans because of species differences in mechanisms of vitamin C entry into RBCs. Therefore, clinical research is essential to characterize vitamin C physiology in RBCs of diabetic subjects. In this protocol we will investigate physiology of vitamin C in RBCs of diabetic subjects as a function of glycemia, without vitamin C supplementation (stage 1) and with vitamin C supplementation (stage 2). We will screen type II diabetic subjects on insulin and/or oral hypoglycemic medication(s) and select those with hemoglobin A1C concentrations of less than or equal to 12%. Selected subjects may be hospitalized twice, each time for approximately one week. The primary objective of the first hospitalization (stage 1) will be to evaluate the effect of hyperglycemia on vitamin C RBC physiology regardless of baseline vitamin C concentrations (without any vitamin C supplementation). The second hospitalization (stage 2) investigates the effect (if any) of vitamin C supplementation to changes in RBC physiology during euglycemic and hyperglycemic states. As inpatients, subjects will have two venous sampling periods each of approximately 24 hours. On admission, subjects may be fitted with continuous glucose monitors (CGMs), oral hypoglycemic agents will be discontinued, and basal-bolus insulin regimen initiated. Insulin doses will be clinically determined and titrated to achieve euglycemia (fasting and pre-meal glucoses <140mg/dl) prior to the first sampling period (euglycemic sampling). The first sampling period will be performed under conditions of euglycemic control for 24 hours. The second sampling period will be performed under controlled hyperglycemia induced by withholding basal and bolus insulin and providing a high carbohydrate load diet (70-75% carbohydrate). Correction-scale insulin will be provided for glucoses >350-400mg/dl. Hyperglycemia will not exceed 9 hours, and will be reversed by reinstituting insulin. During the two sampling periods, samples will be withdrawn via venous catheter for RBC deformability, vitamin C concentrations and other related research studies. Following completion of stage 1, subjects considered for participation in stage 2 will be provided a prescription for vitamin C 500mg twice daily. Given that vitamin C and vitamin E are related antioxidants, and that both vitamins appear to be associated with RBC rigidity, diabetic subjects may also be given a prescription for 400 international units (IU) of vitamin E (RRR alpha tocopherol) daily. Subjects will continue vitamin C and E supplementation for a minimum of 8 weeks depending on RBC vitamin C concentrations. To evaluate any effect of vitamin E supplementation, plasma and RBC vitamin E levels may be measured concurrently with vitamin C levels during various phases of stages 1 and 2. All subjects will be seen as outpatients at biweekly or monthly intervals with regular measurement of plasma and RBC vitamin C concentrations. Target RBC vitamin C concentration >30uM is required prior to stage 2 inpatient sampling studies. Vitamins C and E supplementation will be discontinued upon inpatient admission for stage 2. Risk of both vitamin supplements are minimal as both supplementation doses are safe. Outcomes are to measure RBC rigidity and vitamin concentrations before and after supplementation. After a minimum of 8 weeks (depending on RBC vitamin C levels), subjects will be hospitalized again, and sampling repeated as described. In this manner, each subject serves as his/her own control, and deformability of red blood cells can be determined in relation to glycemia and to vitamin C concentrations in RBCs and plasma.

The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question[s] it aims to answer are: Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C). Effects on systemic inflammation and immune function. Safety and adherence to interventions. Participants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet. Comparisons among groups at 3 and 6 months of intervention will be conducted.

Determine the kinetics of fructose metabolism and its role as a metabolic substrate following a high (100gr/day) vs low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) in type 2 diabetic subjects of SAS or Caucasian ethnicity.

It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.

we will study the impact of using pictograms on improving depression and anxiety among type 2 diabetic patients, we suppose that patients who received pictograms-enriched labels will have lower levels of depression and anxiety in comparison with those who will not receive after three month follow-up evaluation.

Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults with Type 2 Diabetes Mellitus

The aim of this study is to determine the effect of online trainings on diabetic foot care on foot care behavior and self-efficacy attitudes of individuals with type II diabetes. Purpose in accordance with the patient's Diagnostic Information Form, diabetic foot care self-efficacy Scale(DABOO), foot care Behavior Scale(ABDO) and diabetic foot risk screening forms are available in the data collection tools; education and Research Hospital Internal Medicine outpatient clinic with Deeply Izmit Seka state hospital, inpatient or outpatient treatment for persons with Type II diabetes who agree to volunteer to participate in research 90 shall apply. After that, the groups will be divided into two groups by randomization, and one of the groups will be given training sessions consisting of min 20 max 40 minutes for diabetic foot care in 5 sessions for nine weeks. After the training, the scales will be applied to the groups again. The data obtained before and after the training will be compared statistically in a computer environment

The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care (MDC), to evaluate its effect on clinical outcomes.

The overarching aim of this proposal is to test the efficacy of financial incentives in improving HbA1c, blood pressure, and quality of life in food insecure adults with poorly controlled type 2 diabetes. Using a clinical trial design, the investigators will randomize food insecure adults with type 2 diabetes to one of three financial incentive structures in combination with monthly mailings that will include diabetes education, healthy recipes, and meal planning resources.

The purpose of the study is to develop and evaluate a multi-level intervention aimed at increasing access and use of patient portals for diabetes management (MAP) in community health centers (CHCs).