View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).
In a Pediatric University Teaching Hospital in Montreal, an Intelligent Distance Patient Monitoring Program was developed to allow for: - Automatic download of blood glucose levels - Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical team - Changes in treatment plan by the diabetes professionals - E mail exchanges between families and health care professionals - Reinforcement of teaching program Use of this program does not replace the existing diabetes education program nor does it preclude contacts with the diabetes team. This service was devised to complement the care already in place for families of children and adolescents with diabetes, hence the term ''telehomecare-enhanced'' approach. Hypotheses - This approach would not incur more health problems for Web e Phone users when compared to patients treated by the ''conventional'' approach (telephone and FAX). - Use of the Web e Phone would save time for members of the diabetes health providers and consequently cut costs. - This means of communication would be acceptable and user friendly for both families and health care professionals. OBJECTIVE - To determine the effects of a telehomecare (THC) program used for 3 months in families of children and adolescents with newly diagnosed type 1 diabetes. RESEARCH DESIGN AND METHODS - A bilingual telehomecare program was developed for type 1 diabetes at the Centre Hospitalier Universitaire Sainte-Justine in Montreal. Between February 2008 and August 2009, newly diagnosed patients and their family were randomly assigned to the standard education program or to the telehomecare-enhanced group. Outcomes of interest were patients' and parents' health (reported number for total and nocturnal hypoglycemias; quality of life using the Diabetes Quality of life for Youth questionnaire and a validated Life Habits survey); knowledge of diabetes (using pre and post intervention questionnaires); organizational impacts (number and time for contacts with the nurses or with the physician on call) and family satisfaction with the software application.
The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.
The current study is designed to examine the impact of 16 weeks of moderate intensity aerobic training on arterial stiffness and blood pressure in stage 3 chronic kidney disease (CKD) patients. The investigators hypothesize that short term aerobic training will improve the stiffness of arteries in CKD patients.
This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.
A randomized, double-blind, active control trial to determine the safety, efficacy and pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the effect of aleglitazar on renal function, the renin-angiotensin system and the pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to lisinopril for 4 weeks.
The fibrin network is an important component of an arterial thrombus and its structure influences the degradation of the formed clot. A tighter and less permeable fibrin network, which is less susceptible to fibrinolysis, is formed in patients with manifest cardiovascular disease (CVD) or conditions associated with increased risk of atherothrombotic complications. In a previous study we have shown reduced fibrin network permeability in patients with type 1 diabetes, which may contribute to their increased risk of CVD. Low dose aspirin treatment is standard in management of CVD; however, the effect seems reduced in patients with diabetes. Our previous studies have shown that aspirin treatment alters the fibrin network in non-diabetic individuals and increases the fibrin network permeability. The effect of aspirin on fibrin network formation in patients with diabetes is unclear. We hypothesized that patients with type 1 diabetes might need higher doses of aspirin than the recommended low dose (75mg) treatment to gain effects on fibrin network permeability, and that the effects of aspirin treatment on fibrin network in these patients are influenced by the glycemic control.
Introduction Stress is part of the investigators daily life, and means to cope with it allow adaptation and survival. To this end, physiological pathways are activated, including neuroendocrine, cardiovascular and metabolic responses. In short term, the majority of consequences are beneficial, in the long run, however, chronic psychosocial stress may constitute an increased risk for coronary heart disease, type 2 diabetes, and disability. Acute mental stress induces an exaggerated release of stress hormones e.g. catecholamine and cortisol which are thought not only to increase heart rate (HR) and blood pressure (BP) but also to increase blood glucose levels. In clinical practice, patients and health care providers are often confronted with questions concerning psychological stress as a possible reason for glucose fluctuations. Whether stress itself or poor treatment adherence is responsible for the altered glucose control remains often controversial. Differences in the inter- and intraindividual response to stress have been suggested, but only a few small studies have addressed the effect of acute psychological stress on glucose control in patients with diabetes. Patients with type 2 diabetes may overestimate the effect of acute psychological stress on glucose control but further studies are clearly needed to definitely exclude or confirm a relevant effect of stress on the glucose control in diabetic patients. For example, effects of longer lasting or repetitive events of psychological stress on glucose concentrations still remain elusive. The aim of the present study was therefore to investigate the effect of prolonged psychological stress by means of repetitive safe driving training courses on glucose control in patients with diabetes. Patients and Methods Forty patients with type 1 or insulin-treated type 2 diabetes attending the outpatient-clinic of the Kantonsspital Frauenfeld or University Hospital of Zurich for regular visits are invited to participate. Included are patients on any oral glucose-lowering treatment and at least one daily injection of insulin, a valid driver license and written informed consent given. Exclusion criteria are diabetes duration <2 years, pregnancy, unstable coronary artery disease, limited visual acuity or unstable proliferative diabetic retinopathy, uncontrolled hypertension (BP >160/95mmHg) and pituitary or adrenal disease. The Ethics committee of the Kanton Thurgau approved the protocol and the study conform to the principles outlined in the Declaration of Helsinki. Study protocol Each patient completes a control and a stress testing day which takes place consecutively in a randomized order. Randomization is performed by an uninvolved third person. The study is carried out at the driving training area of the Touring Club Switzerland at Hinwil. Patients are advised to have lunch before 12:00 a.m. and to abstain from food thenceforth. Drinking mineral water remains allowed during the entire study days, and the patients have to take their basal insulin and other medication as usual. Patients are advised to arrive at the driving training area between 2:30 and 3:00 p.m. At arrival, a capillary glucose measurement is carried out, and glucose concentrations ≥10mmol/l are corrected with short-acting insulin analogues (glucose target 6 - 8mmol/l). Subsequently, no additional adjustment with insulin is allowed during the study. Glucose concentrations ≤4mmol/l are always corrected with administration of 10g carbohydrate (DextroEnergy® or orange juice). On both study days, patients ingest a standard meal at 4:45 p.m. (i.e. 15min before the driving training). Immediately after the meal, short-acting insulin is injected in knowledge of the carbohydrate content (same dose on both days) or oral antidiabetics are ingested as usual. Measurements of capillary and plasma glucose concentration, blood pressure, heart rate, stress perception and salivary cortisol concentration are carried out in regular intervals between 4 and 9 p.m. on both study days. On the control day, patients are placed in a quiet room and are permitted to read. They also have the possibility to leave the room and stay on a balcony. On the stress testing day, patients complete a driving training with their car between 5 and 7 p.m. The driving training consists of 3 consecutive exercises: first, a slalom track on dry and wet asphalt, secondly, a full braking exercise with water obstacles. Thirdly, the car is hurled around by a mechanical plate and the patients has to regain control over it.
This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple ascending doses of PF-05231023.