Clinical trial NCT00542178
Conditions: Diabetic Retinopathy
Keywords: Type 2 Diabetes Mellitus Cardiovascular Diseases
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Start date: 2003-10-01; Completion date: 2009-12-01
Enrollment: 3472 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study is examining the effect of various treatments on cardiovascular disease in people with diabetes. This current study will examine the effects of the ACCORD treatments on the progression of DR in people participating in the ACCORD study.

Detailed description:
DR is the most common diabetic eye disease and is the leading cause of blindness in adults in the United States. It is caused by damage to the blood vessels of the retina, which is the light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high blood sugar levels associated with diabetes. Older people have an increased risk of developing DR; however, DR is likely to occur earlier and be more severe in anyone who has poorly controlled diabetes. Almost everyone who has had diabetes for more than 30 years will eventually show signs of DR. Symptoms of DR include poor night vision, seeing spots in front of the eyes, blurred vision, and blindness. The ACCORD study is a study that is examining the effects of different treatments on cardiovascular disease in people with diabetes. Participants in the ACCORD study will receive one of eight different combinations of treatment, including blood sugar control, blood pressure control, and cholesterol-controlling medication. This study will enroll participants in the ACCORD study and will examine the effects of the study treatments on DR. The results from this study may be used to develop new treatments to help prevent diabetes-related blindness.

Study visits will occur at baseline and Year 4. At each study visit, participants will have an eye exam and specialized fundus photographs taken of the back of the eye and retina.

Arms: arm 1: A strategy of intensive glycemia treatment to HbA1c less than 6% arm 2: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9% arm 3: A strategy of BP treatment for SBP less than 120 mm Hg arm 4: A strategy of BP treatment for SBP less than 140 mm Hg arm 5: Blinded fenofibrate + simvastatin 20-40 mg/d arm 6: Blinded placebo + simvastatin 20-40 mg/d
Interventions: intervention 1: Hypoglycemic Agents intervention 2: Standard glycemia control intervention 3: Intensive BP treatment intervention 4: Standard BP control intervention 5: Fenofibrate intervention 6: Simvastatin intervention 7: Placebo
Intervention descriptions: intervention 1: Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6% intervention 2: A strategy of glycemia drugs for HbA1c 7% - 7.9% intervention 3: A strategy of multiple BP agents to reduce SBP less than 120 mm Hg intervention 4: A strategy of BP drugs for SBP less than 140 mm Hg intervention 5: Blinded fenofibrate intervention 6: Simvastatin 20-40 mg/d intervention 7: Placebo

Protocol documents: