View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:To examine the effect of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) on metabolic control, in a large population-based nationwide observational study under real life conditions. All children and adolescents with type 1 diabetes are investigated,using annual data in 2017 from the population-based Norwegian Childhood Diabetes Registry (NCDR). HbA1c, incidence of diabetes ketoacidosis (DKA) and severe hypoglycemia (SH) are evaluated depending on the use of CSII and CGM in a linear mixed-effects and linear regression model adjusted for age, biologic gender and diabetes duration. Health-related quality of Life (HRQOL) is assessed by using the DISABKIDS diabetes specific module (DDM-10), and associations with the use of CSII, CGM, age, gender and diabetes duration are evaluated.
This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period. Participants may be enrolled initially into a screening protocol and then transfer into the RCT protocol, or they may enter directly into the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care (UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System for 3 months. At the completion of use of the BP system in the RCT only, participants will enter a 2-4 day Transition Phase and be randomly assigned to either transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP System or transition back to their usual mode of therapy based on what their own insulin regimens were prior to enrolling in the RCT. There is an optional ancillary study to assess the safety of utilizing self-monitored blood glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input into the iLet for ~48-60 hours. The Study is intended to mirror a real-world situation where CGM may not be available for an extended period of time (eg, user runs out of sensors and is awaiting new shipment).
Proton pump inhibitors (PPIs) are treatment of choice for different gastrointestinal disorders common in type 2 diabetes. Sulfonylureas (SUs) are anti-diabetes agents particularly widely used in developing countries. Gliclazide, a recommended SU drug, is metabolised in part by CYP2C19, the main enzyme responsible for the PPI metabolism. A randomised, placebo-controlled, two-sequence, two-period crossover study will be performed to explore whether gliclazide pharmacokinetics (PK) and pharmacodynamics (PD) are altered upon co-administration with omeprazole. Sixteen healthy volunteers, CYP2C19 extensive/ultrarapid metabolisers (EM/UM), will receive placebo or omeprazole alone for 4 days, and concomitantly with single dose of gliclazide on day 5. Plasma concentration of gliclazide will be measured for 24 hours, and plasma glucose and insulin levels up to 12 hours after gliclazide administration.
The study is a two-arm parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness and feasibility of using high-quality medication reminder smartphone application as a tool for secondary prevention in patients undergone CABG with DM, including the change in quality of life, medication adherence improvement and clinical outcome. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive information of secondary prevention of CHD and medication alarm using a specific smartphone application, while the control group will receive usual care.
Diabetes Mellitus type 2 (T2DM) is a chronic and progressive disease, characterized mainly by hyperglycemia. Metabolic imbalance causes an increased risk of microvascular and macrovascular complications associated with the increased prevalence of cardiovascular disease (CVD) in diabetics. Although genetic predisposition determines individual susceptibility to T2DM, external factors such as an unhealthy diet and a sedentary lifestyle condition the onset of the disease. Since T2DM is a multifactorial disease, many authors have studied the possible role of the microbiota and its alterations in the pathophysiology of the disease. There is evidence that in T2DM there are alterations in the proportion of Firmicutes, Bacteroidetes and Proteobacteria, and a smaller amount of bifidobacteria with anti-inflammatory properties. Probiotics are living microorganisms present in food that, if consumed in sufficient quantities, can improve health. In general, probiotics protect the patient through immunomodulation, protecting him from infections, increasing the activation of mononuclear cells and lymphocytes. The investigational product is a supplement to the probiotic Bifidobacterium animalis subsp. lactis (BPL-1) CECT 8145. There are numerous studies carried out on different strains of GLP-1 that demonstrate its safety. Many of them are commonly used in the food industry, not only because of their proven safety, but also because of their viability until consumption. This clinical trial is proposed as an interdisciplinary study that can contribute to the characterization of the efficacy of treatment with probiotics in patients with T2DM of different stages of evolution, without and with hepatic involvement.
Monocentric, randomised, controlled and open study. Subjects will be included prospectively and consecutively and randomly assigned into two groups. Intervention group A will benefit a medication adherence support program during 12 months while intervention group B during 6 months only. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visit, the pharmacist will conduct a semi-structured interview in 15 minutes based on Fisher's sociocognitive model with the patients. A summary of the interview and the adherence graph will be send to the patient' health professionals.
This study in healthy men and women looks at the injection site experience of semaglutide and dulaglutide given subcutaneously (s.c., under the skin). Participants will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day. The 2 injections will be given at least 30 minutes apart, one in each side of the stomach. Participants will be in the clinic research center for 1 day. A follow-up phone call will take place between 4 and 5 weeks after the injections were given.
The aim of the study is to research psychosocial and socioeconomic factors among families that might affect glycemic control in children and adolescent with type 1 diabetes mellitus. These factors might be: living conditions, structure of the family, socioeconomic status, divorces and parent's own glycemic control status (if parent's type 1 diabetes mellitus is present in the family).
Aim: To estimate an oral administered recommended minimum efficacy daily dose (MED) of Jarlsberg cheese in order to obtain the needed increased level of Osteocalcin defined as the ratio [Carboxylated / Under Carboxylated] Osteocalcin. Study population: Healthy Voluntary (HV) women between 20 years and pre-menopausal age. Design: Open and randomised two-dimensional single-centre trial with 3-level between-patient Response Surface Pathway (RSP) design in the first dimension and 3-level within-patient RSP design in the secondary dimension.
In addition to its effect on maintaining calcium homeostasis and mineralization of bone, vitamin D has been linked to play a pivotal role in different medical conditions including type 2 diabetes mellitus. Vitamin D plays a major role in both insulin secretion and decreasing the insulin resistance hence has a major impact on glucose tolerance. This study is designed to determine the non-skeletal effects of vitamin D in improving the glucose tolerance in type 2 diabetic patients by decreasing the insulin resistance