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Action to Control Cardiovascular Risk in Diabetes (ACCORD)

2014-08-27 04:00:03 | BioPortfolio

Summary

The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.

Description

BACKGROUND:

Currently, about 17 million Americans have been diagnosed with diabetes and more than 90 percent of them have type 2 diabetes. The number of people with this form of diabetes, formerly known as adult onset or non-insulin dependent diabetes, is growing rapidly. By 2050, the number of Americans with diagnosed diabetes is projected to increase by 165 percent to 29 million, of whom 27 million will have the type 2 form. Cardiovascular disease (CVD) is the leading cause of death in people with type 2 diabetes; these individuals die of CVD at rates two to four times higher than those who do not have diabetes. They also experience more nonfatal heart attacks and strokes.

Type 2 diabetes is associated with older age and is more common in those who are overweight or obese and have a family history of diabetes. Women with a history of diabetes during pregnancy, adults with impaired glucose tolerance, people with a sedentary lifestyle, and members of a minority race/ethnicity are also at a greater risk for developing type 2 diabetes. African Americans, Hispanic/Latino Americans, American Indians, and some Asian Americans and Pacific Islanders are at particularly high risk for type 2 diabetes.

DESIGN NARRATIVE:

The three strategies tested in ACCORD will include the following: (1) Blood sugar - ACCORD will determine whether lowering blood glucose to a level closer to normal than called for in current guidelines reduces CVD risk. The study will determine effects on CVD of that level compared with a level that is usually targeted. (2) Blood pressure - Many people with type 2 diabetes have high blood pressure. The blood pressure part of the trial will determine the effects of lowering blood pressure in the context of good blood sugar control. ACCORD will determine whether lowering blood pressure to normal (systolic pressure less than 120 mm Hg) will better reduce CVD risk, as compared to a usually-targeted level in current clinical practice (i.e., below the definition of hypertension; systolic pressure less than 140 mm Hg). (3) Blood Fats - Many people with diabetes have high levels of LDL ("bad") cholesterol and triglycerides, as well as low levels of HDL ("good") cholesterol. ACCORD participants who are selected for this part of the trial will be assigned to an intervention that improves blood fat levels. This part of the study will look at the effects of lowering LDL cholesterol and blood triglycerides and increasing HDL cholesterol compared to an intervention that only lowers LDL cholesterol, all in the context of good blood sugar control. A drug from a class of drugs called "fibrates" will be used to lower triglycerides and increase HDL cholesterol, whereas a drug from the class of drugs called "statins" will be used to lower LDL cholesterol.

All ACCORD participants will receive their blood sugar treatment from the study. Based on whatever else they are assigned to, participants will also receive their cholesterol or high blood pressure care from the study. Study participants will receive all medication and treatments related to the study free of charge. Individuals who are selected and consent to participate in the ACCORD study will continue to see their personal physician for all other health care.

The ACCORD clinical trial enrolled 10,251 adults with type 2 diabetes in 77 clinics around the United States and Canada. All eligible participants will be in the blood sugar control part of the trial. Participants were randomly assigned to a treatment regimen involving either aggressive control or standard control of blood sugar. Then, depending on their blood pressure and cholesterol levels, they were assigned to either the high blood pressure or high blood fats (cholesterol and triglycerides) part of the study.

On February 6, 2008, the NHLBI announced that participants in the intensive glycemia treatment will be transitioned to the ACCORD standard treatment approach due to higher mortality in the intensive treatment group. The blood pressure and lipid trials are continuing as designed.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Atherosclerosis

Intervention

Hypoglycemic Agents, Intensive BP treatment, Fenofibrate + simvastatin, Standard glycemia control, Standard BP control

Location

Minneapolis Medical Research Foundation
Minneapolis
Minnesota
United States
55404

Status

Active, not recruiting

Source

National Heart, Lung, and Blood Institute (NHLBI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:03-0400

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Medical and Biotech [MESH] Definitions

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