Active clinical trials for "Diabetes Mellitus, Type 2"

Rationale: The global prevalence of diabetes, along with its devastating effects on life expectancy and quality of life, continues to increase. Worldwide, the total number of people with diabetes is projected to rise from about 171 million in 2000 to 336 million in the year 2030. Type 2 diabetes accounts for about 85 percent to 95 percent of all diagnosed cases of diabetes and is associated with a number of serious long-term complications, which are a major cause of morbidity, hospitalization and mortality in diabetic patients. More evidence is becoming available that both lifestyle and clinical intervention in the pre-diabetic condition are effective in slowing down progression of pre-diabetes to overt diabetes. Over many centuries, several forms of traditional medicine have developed which are often based on fundamental principles that differ from those of "Western" medicine. One of the most prominent characteristics of Traditional Chinese Medicine (TCM), is a more holistic approach to the functioning and disfunctioning of living organisms. Every healthy organism is in a Yin Yang balance and is considered to be a complex interplay between body and mind. Western medicine relies on detailed classification of diseases, empirical investigations and treatments targeting those disorders. However, "Western medicine" is showing an increased interest in traditional forms of medicine. Objectives: The primary objective of the present study is to determine consistency in classification of DM type 2 in three categories as defined by Traditional Chinese Medicine (TCM) in pre-diabetic subjects. Secondary objectives are to find relationships between diagnosis according to TCM and risk profile according to Western approach (fasting glucose and HbA1c in plasma, age, BMI, waist circumference). Another objective is to find relationships between classification of risk for DM type 2 according to TCM and objective parameters.

CSP 465-B, Correlation of Plasma Endothelial Cell (Basic Fibroblast Growth Factor) Activity With Cardiovascular Events in Patients with Diabetes Mellitus, Type II. Mark Zimering M.D. Objectives: Endothelial cell dysfunction plays a role in the development of the atherosclerotic vascular lesion and it is also thought to provide a mechanism for increased urinary albumin excretion in type 2 diabetes mellitus. Micro- or macroalbuminuria are associated with increased cardiovascular (CV) morbidity and mortality in type 2 diabetes mellitus. In at least one longitudinal study in older-age onset patients, micro-or macroalbuminuria robustly predicted increased CV risk independent of other diabetes-related factors.1 The pathogenetic mechanisms underlying a significant association between micro- or macroalbuminuria and CV risk in diabetes mellitus are not known but may include: growth factors, clotting factors, lipids, or hemodynamic factors. The aim of the present study is to investigate whether an angiogenic growth factor, basic fibroblast growth factor (bFGF), plays a role in increased CV risk in type 2 diabetes mellitus. Research Plan: BFGF (FGF-2) is one of the most potent known angiogenesis factors. Increased bFGF was previously associated with both endothelial cell injury and micro- or macroalbuminuria. In a prior study of 73 older-age onset veterans with type 2 diabetes mellitus (JCEM, 1996), we found plasma endothelial cell (bFGF) activity was significantly associated with glycemic levels, and (in multiple regression analysis) independently associated with both microalbuminuria and retinopathy. We will test whether plasma endothelial cell (bFGF) activity is significantly, independently associated with a pooled endpoint of cardiovascular events that includes myocardial infarction (MI), coronary revascularization, congestive heart failure (CHF), or CV mortality. We expect that increased bFGF may itself be a robust marker for increased CV risk in diabetes mellitus for three reasons. First, because bFGF was independently associated with (micro)-albuminuria in type 2 diabetes mellitus. Second, because increased bFGF was associated with increased activity in the renin-angiotensin system in vascular smooth muscle cells (Dzau, et al. JCI, 1995). And third, because (as we reported) angiotensin converting enzyme inhibitor (ACEi) drugs substantially decreased plasma bFGF levels in (micro)- albuminuric diabetes mellitus type 2, and (as others reported) ACEi drugs substantially reduced the risk of development of CHF in patients with LVH 2, the risk of mortality after MI (8,9), and the risk of CV death in diabetic patients with proteinuria. Because plasma endothelial cell (bFGF) activity correlated significantly with glycemic levels in diabetes mellitus type 2, plasma bFGF may be one of the pathogenetic links between glycemic levels and an increased risk of cardiovascular events in diabetes mellitus, type 2. Methods: Blood (3 mL EDTA plasma) will be collected from each subject in Years 1, and 2 of the Study at each of 6 local participating VA substudy sites. Because plasma endothelial cell (bFGF-like) bioactivity and bFGFR-IR in vivo are stable for months and years based on our prior published studies (1-3), we anticipate that obtaining 2 specimens, 1 each in Years 1, 2 of the study, will provide sufficient data to model proportional risk.

The study tests whether implementing professional evidence-based guidelines and best practices for diabetes care -through participation of multidisciplinary teams in a Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes and economic costs. Determinants of success are studied. Data on diabetes will also be used to better understand Breakthrough as an implementation or improvement method.

To evaluate very low density lipoprotein (VLDL) and low density lipoprotein (LDL) particle types as predictors of initial coronary events.

This is a questionnaire based study (no study drug is involved) that asks if more patients with uncontrolled type 2 diabetes on diabetes pills will choose insulin as the next treatment choice if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments. This study will also ask if patients with uncontrolled type 2 diabetes currently managed on diabetes pills + once daily insulin will choose as the next treatment choice to take insulin multiple times a day if inhaled insulin were available in addition to all currently available treatments, compared with if inhaled insulin was not available as part of currently available treatments.

The purpose of this study is to investigate the changes of cardiorespiratory fitness and left ventricular function in type 2 diabetes after uncomplicated coronary artery bypass graft (CABG) surgery. We hypothesize that exercise capacity, left ventricular diastolic function, and biochemical data improves after 12-wk exercise training in patients with type 2 diabetes underwent CABG.

To test whether novel cardiovascular risk factors are related to the presence and development of atherosclerosis and macrovascular events in Type 2 diabetes mellitus and to determine whether intensive glucose lowering therapy will reduce the levels of these cardiovascular risk factors.

To evaluate the relationship of baseline toenail chromium concentrations to weight loss, as well as the interaction between heavy metals and the beneficial effects of weight loss.

To evaluate additional cardiovascular risk factors using data from the VA HDL Intervention Trial (VA-HIT).

To determine the incidence of type II diabetes and cardiovascular disease among Mexican-American and non-Hispanic whites in a 15 to 24 year follow-up of the San Antonio Heart Study 1 participants. Also, to perform a 15 to 24 year mortality follow-up of the cohort and to examine the "Hispanic paradox".