
A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons...
Diabetes MellitusType 2This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.

The FLAVO Trial: Dietary Flavonoids and Cardiovascular Disease Risk Reduction in Postmenopausal...
Cardiovascular DiseaseDiabetesThe purpose of this placebo controlled trial is to determine whether a year long intervention with flavonoids (found in cocoa and soy) is more effective in reducing the risk of cardiovascular disease in postmenopausal women with type 2 diabetes, than standard therapy (statins). A range of markers of cardiovascular disease risk are being studied and volunteers are also providing urine and blood samples. 152 postmenopausal women, from the locality, will be recruited for this study.

Copenhagen Obesity Risk Assessment Study
Metabolic SyndromeAbdominal Obesity2 moreThe aim of the present study is to assess the effect of a high intake of industrially produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2 diabetes and heart disease in healthy, moderately overweight, postmenopausal women.

Lifestyle Intervention in a General Population for Prevention of Ischaemic Heart Disease
CHDAMI3 moreIn spite of declining trend coronary heart disease (CHD) is still a leading cause of morbidity and mortality. Many years of epidemiological research have identified several risk factors for CHD. The main causes are physical inactivity and inappropriate diet (mediated through high blood pressure, high cholesterol and fatness) and smoking. So far intervention studies on lifestyle factors have shown disappointing results, most probably due to insufficient interventions and methodology. Inter99 is a randomized non-pharmacological intervention study comprising 61,301 persons representing a well-defined population. About 13,000 are invited for a health examination and assessment of risk for CHD. Those at high risk are offered lifestyle intervention in three waves over a five year period. A priori the group is divided into a high intensive and low intensive intervention group. The remaining 48.285 individuals serve as control. After five years all individuals who attended the base-line examination are re-invited to assess the effect of the intervention on intermediate end-points as lifestyle, absolute risk of CHD and biological risk factors. The total cohort (61.301) is followed through central registers to evaluate the effect of the intervention on use of the health care system and the long term effect on incidence of CHD. The status for the project is that the four waves of intervention have been performed, the last follow-up was in March 2006. Data collection finalized with 10 years follow-up via Central National Registries and a questionnaire. No further follow-up is scheduled for the main purposes of the study. Analyses as regard the primary effect (on incidence of cardiovascular diseases) and secondary effect (on incidence of type 2 diabetes) are on-going. Analyses for a large number of spin off project are on-going. More than 25 Ph.d. studies and more than 200 peer-review publication have so far been produced. Summary of results, links to articles and theses at: www.Inter99.dk

Weight Loss Maintenance (WLM)
Cardiovascular DiseasesHeart Diseases4 moreTo determine the effectiveness of continuous patient contact on weight loss maintenance.

Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk
AtherosclerosisCardiovascular Disease3 moreThe hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications. The objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects with IGT and changes in glucose area under the curve following a standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation, respectively; and (3)also determine whether salsalate therapy improves parameters of cardiovascular disease risk, including features of metabolic syndrome (fasting glucose, triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.

Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
Coronary DiseaseArteriosclerosis2 moreThe purpose of this study is to determine the effects of low-dose aspirin for the primary prevention of vascular events in patients with type 2 diabetes in Japan.

Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes
HypertensionType 2 Diabetes MellitusThe purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.

Blood Pressure and Glucose Lowering for the Prevention of Vascular Disease in High Risk Patients...
Diabetes MellitusType 2The purpose of this study is to provide information on the risks and benefits of routine blood pressure lowering (regardless of blood pressure level), and intensive lowering of blood glucose levels, in patients with Type 2 diabetes at high risk of cardiovascular events. The major outcomes of the study will be cardiovascular events (heart attack, stroke or dying as a result of cardiovascular disease), as well as new or worsening diabetic eye and kidney disease.

Metabolic Causes of Thrombosis in Type 2 Diabetes Mellitus
Type 2 DiabetesThe purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. The proposed protocol will study the separate and combined effects of high glucose and high fats on certain cardiovascular responses in Type 2 DM.