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Current ResearchThe MMRF is researching new drug therapies and new technologies to help people with diabetes and obesity live healthier lives. Weight Loss MMRF investigators are involved in a 2-year research study that provides intensive nutrition and exercise counseling and the opportunity to take an investigational weight loss medication. The study medication has not been approved by the U.S. Food and Drug Administration (FDA) or any other Health Authority and is only available to subjects participating in a research study. The purpose of the study is to assess the safety and efficacy of ecopipam when used to treat obesity. Ecopipam is a drug that may prove to be effective in treating obesity, and therefore, we are currently gathering data to allow us to gain approval from the FDA so that ecopipam can be used to treat patients with mild to moderate obesity. We will be comparing one daily oral dose of ecopipam with placebo. Whether participants will receive ecopipam or placebo will be decided by a process called randomization (as in the flip of a coin). The chance of receiving the investigational drug, ecopipam, is 50%. Weight Loss and Diabetes The MMRF is also participating in the Study of Health Outcomes of Weight Loss (SHOW) study which is a multicenter, randomized, clinical trial designed to examine the effects of sustained weight loss on atherosclerotic disease progression in individuals with Type 2 diabetes. The SHOW trial will have three study arms 1) community care, 2) lifestyle intervention (diet, physical activity, and behavioral counseling, and 3) lifestyle intervention plus pharmacologic (medication) intervention. Diabetes Therapies MMRF researchers are involved in a study is to compare the effectiveness and safety of insulin glargine to a conventional depot insulin (NPH human insulin) in subjects with type 2 diabetes. Insulin glargine is a recombinant human insulin analogue, the structure of which has been modified in comparison with human insulin, resulting in delayed absorption and a longer duration of action. This provides a more stable insulin supply to the body. Type 2 diabetes is a chronic illness that generally requires a special diet, life-long treatment with oral blood glucose-lowering drugs and/or insulin. It is important that blood glucose levels remain approximately within the normal range if the late complications of diabetes are to be decreased or delayed. The treatment of choice to achieve good metabolic control depends on the stage of diabetes progression. If oral antidiabetic drug (oral hypoglycemic agent(s)) treatment is no longer sufficient to achieve good metabolic control, insulins can be added into the treatment. This is known as insulin/oral hypoglycemic agent(s)) combination treatment. The insulin generally used is a depot insulin, most commonly NPH human insulin. However, since NPH insulin has only a limited duration of action, it is unable to maintain the even spread of insulin levels throughout the day which is essential for optimal metabolic control Heart Disease in Diabetics MMRF researchers at the Hennepin Center For Diabetes & Metabolism will be involved in a national historic study that will attempt to determine the best treatment for prevention of heart disease in persons with Type 2 diabetes. The Prevention of Cardiovascular Disease in Diabetes (PCDD) trial will study whether better control of blood sugar helps lower the risk of heart disease in people with Type 2 diabetes. The study will also look at the role of aggressive risk factor lowering — getting blood pressure and blood cholesterol to very low levels. Enrollment in the study will begin in fall 2000.
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