Glycemic control and complications in type II diabetes. Design of a feasibility trial. VA CS Group (CSDM)
OBJECTIVE
To determine, after 1 yr of follow-up in type II diabetes patients, whether a statistically and clinically significant difference can be achieved in HbA1c between a standard therapy group and an intensively treated group, while maintaining HbA1c levels in both groups within ranges acceptable in regular community practice. Secondary objectives include assessment of patient adherence to protocol, side effects, and accuracy of data collection.


METHODS
This is a prospective, randomized, controlled VA CS conducted with 151 patients at five VAMCs. Patients are males, age 40-69 yr, treated at entry with a maximum dose of sulfonylurea or with insulin, exhibiting an HbA1c level > 3 SDs above the normal mean (5.05 + 3 x 0.50 = > 6.55%). Standard control is achieved with insulin and intensive control with a step-up regimen including insulin alone or insulin/glipizide combinations. Education and management of cardiovascular risk factors are handled similarly in both groups. Primary macrovascular end points are nonfatal myocardial infarction, congestive heart failure, stroke, amputation, and cardiovascular death. Primary microvascular end points are appearance and progression of retinopathy, documented by centrally read seven-field-stereo fundus photographs. Other measured indicators include resting and ambulatory ECGs, ventricular function (MUGA scan), serum lipid and apolipoprotein levels, plasma fibrinogen, nonsymptomatic peripheral vasculopathy, neuroautonomic status by heart-beat variation on Valsalva maneuver, and microalbuminuria.


CONCLUSIONS
This study may be the basis for a long-term trial, involving 1400 patients, to assess the long-term effects of metabolic control on macro- and microvascular end points.
Abraira
C
C
Department of Veterans Affairs Cooperative Studies Program, Hines VA Hospital, Il 60141.
Emanuele
N
N
Colwell
J
J
Henderson
W
W
Comstock
J
J
Levin
S
S
Nuttall
F
F
Sawin
C
C
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000503:physiopathology / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000453:epidemiology / Q000517:prevention & control*; D004562:Electrocardiography; D005240:Feasibility Studies; D005500:Follow-Up Studies; D005913:Glipizide / Q000627:therapeutic use; D006442:Glycated Hemoglobin / Q000032:analysis* / Q000378:metabolism; D006801:Humans; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic; D012307:Risk Factors
D001786:Blood Glucose; D005913:Glipizide; D006442:Glycated Hemoglobin; D007328:Insulin