Diabetes Dateline

Two New Federal Studies Related to Diabetes Announced

The National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) have announced the start of two large clinical trials designed to identify ways to reduce the cardiovascular complications of type 2 diabetes.

Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial is a federally funded, multicenter study designed to test medical treatments for reducing cardiovascular disease (CVD) morbidity and mortality in people with type 2 diabetes.

Diabetes has long been recognized as a risk factor for CVD in men and women, and cardiovascular complications are the leading cause of illness and death in people with diabetes. People with type 2 diabetes have a CVD-related mortality rate that is two to four times higher than people with similar characteristics who don't have diabetes.

The ACCORD trial will test the effects of three treatment strategies on CVD event rates:

• Treatment to achieve intensive glycemic control that aims for a hemoglobin A-1-c level of less than 6 percent (compared to a level of less than 7.5 percent).
  
  
• Treatment to raise high density lipoprotein (HDL) cholesterol and lower triglyceride levels in the context of glycemic control and desirable low density lipoprotein (LDL) cholesterol levels (compared with targeting only desirable LDL cholesterol levels and glycemic control).
  
  
• Treatment to achieve intensive blood pressure control that aims for a systolic blood pressure of less than 120 mm Hg, in the context of glycemic control (compared with systolic blood pressure of less than 140 mm Hg).

Recruitment for the ACCORD trial begins in late fall 2000 and will continue for 3 years. The 10,000 participants (middle-aged or older people with type 2 diabetes who are at high risk for CVD) will be followed for 4 to 7 years. The 59 clinical sites will be located throughout the United States and Canada. Results of the trial will be announced by the end of 2007.

Study of Health Outcomes of Weight-Loss

The Study of Health Outcomes of Weight-Loss (SHOW) trial, currently in the planning stages, will be a national multicenter, randomized clinical trial designed to study the effect of weight-loss interventions in obese people with type 2 diabetes. Cardiovascular disease will be the main measure.

This type of clinical trial was highly recommended by members of the National Task Force on Prevention and Treatment of Obesity. The study is sponsored by NIDDK's Division of Digestive Diseases and Nutrition with assistance from the Division of Nutrition Research Coordination; the National Institute of Nursing Research; the Office of Research on Women's Health; the National Institute of Environmental Health Sciences; the National Heart, Lung, and Blood Institute; and the Centers for Disease Control and Prevention.

Clinical centers for SHOW are as follows:

• Baylor College of Medicine, Houston, TX
• Johns Hopkins University, Baltimore, MD
• Massachusetts General Hospital, Boston, MA
• The Miriam Hospital, Providence, RI
• Pennington Biomedical Research Center, Baton Rouge, LA
• St. Luke's-Roosevelt Institute for Health Sciences, New York, NY
• University of Alabama at Birmingham, Birmingham, AL
• University of California at Los Angeles, Los Angeles, CA
• University of Colorado Health Sciences Center, Denver, CO
• University of Minnesota, Minneapolis, MN
• University of Pennsylvania, Philadelphia, PA
• University of Pittsburgh, Pittsburgh, PA
• University of Tennessee, Memphis, TN
• University of Texas Health Science Center, San Antonio, TX
• University of Washington, Seattle, WA

Also, a Southwest American Indian center has been established at the NIDDK Phoenix Epidemiology and Clinical Research Branch in Arizona. The clinical centers expect to start enrolling 6,000 volunteers in early 2001. The coordinating center will be Wake Forest University in Winston-Salem, NC.

Diabetes Prevention Trial—Type 1 Update

The Diabetes Prevention Trial—Type 1 (DPT-1) is a national study to find out if type 1 diabetes can be prevented or delayed. DPT-1 is still recruiting volunteers. For more information on the study, or if you (or a member of your family) are under 40 and have a relative with type 1 diabetes, you (or that family member) may be eligible. To learn what the benefits of participation are, please contact the Diabetes Prevention Program at 1–800–HALT–DM1 or at www.diabetes.niddk.nih.gov/dm/pubs/preventionprogram/index.htm on the Internet.

[Top]