Related Experiment Videos
The ABCD (Appropriate Blood Pressure Control in Diabetes) trial. Rationale and design of a trial of hypertension
S Savage1, N Johnson Nagel, R O Estacio
1University of Colorado Health Sciences Center, Denver 80206.
Insights
The Appropriate Blood Pressure Control in Diabetes (ABCD) Trial investigates if intensive blood pressure control reduces diabetic complications. This study compares intensive versus moderate antihypertensive therapy in type II diabetes patients.
Area of Science:
- Cardiology
- Nephrology
- Endocrinology
Background:
- Hypertension is a significant risk factor for end-organ complications in type II diabetes.
- Understanding optimal blood pressure targets is crucial for managing diabetic nephropathy, retinopathy, and cardiovascular disease.
Purpose of the Study:
- To evaluate the efficacy of intensive versus moderate antihypertensive control on type II diabetic end-organ complications.
- To compare the effects of enalapril and nisoldipine on these complications.
Main Methods:
- Prospective, randomized, double-blind, controlled trial with 5-year follow-up.
- Inclusion of type II diabetic patients (40-74 years) with diastolic blood pressure ≥ 80 mmHg.
- Randomization to intensive or moderate antihypertensive therapy and to enalapril or nisoldipine.
Main Results:
- Primary outcome: glomerular filtration rate (creatinine clearance).
- Secondary outcomes: microalbuminuria, left ventricular hypertrophy, retinopathy, neuropathy, cardiovascular morbidity, and mortality.
- Data collection occurred at the Colorado Prevention Center.
Conclusions:
- The ABCD Trial aims to provide clinically relevant findings on hypertension management in type II diabetes.
- Results are expected to clarify the benefits of intensive antihypertensive therapy in preventing or delaying diabetic end-organ damage.
Objective:
The primary objective of the ABCD (Appropriate Blood Pressure Control in Diabetes) Trial is to determine the efficacy of intensive versus moderate antihypertensive control on the outcome of type II diabetic end-organ complications in normotensive and hypertensive populations. The secondary objective is to determine whether any differential effect on end-organ complications exists between an angiotensin converting enzyme inhibitor (enalapril) and a calcium channel blocker (nisoldipine).
Design:
The ABCD Trial is a prospective, controlled, randomized, double-blind trial, with a planned follow-up of 5 years.
Setting:
All patients are seen at the Colorado Prevention Center, site of the ABCD Trial, for follow-up visits.
Patients:
Patients are type II diabetic males and females between the ages of 40 and 74 years with entry diastolic blood pressures > or = 80 mmHg. Patients were recruited from University of Colorado-affiliated hospitals, several health maintenance organizations, and mailing lists from the Colorado affiliate of the American Diabetes Association.
Interventions:
Patients were randomized to intensive antihypertensive drug therapy or moderate antihypertensive drug therapy. Patients were also randomized to nisoldipine or enalapril, with open-label medications added if further blood pressure control was necessary.
Main Outcome Measures:
The primary outcome measure is glomerular filtration rate as assessed by 24-hour creatinine clearance. Secondary outcome measures are microalbumin urinary excretion, left ventricular hypertrophy, retinopathy, and neuropathy. Cardiovascular morbidity and mortality will also be evaluated.
Conclusion:
Given the data showing the impact of hypertension on diabetic complications, the ABCD Trial was designed to determine if intensive antihypertensive therapy will be more efficacious than moderate antihypertensive therapy on the outcome of these complications. Results from the ABCD Trial are expected to lend interpretable and clinically relevant findings with regards to the treatment of hypertension in type II diabetes.