Glycemic control and complications in type II diabetes: Design of a feasibility trial

C. Abraira, N. Emanuele, J. Colwell, W. Henderson, J. Comstock, S. Levin, frank q Nuttall, C. Sawin

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53 Scopus citations

Abstract

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 HbA(1c) between a standard therapy group and an intensively treated group, while maintaining HbA(1c) 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. RESEARCH DESIGN AND 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 HbA(1c), 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.

Original languageEnglish (US)
Pages (from-to)1560-1571
Number of pages12
JournalDiabetes Care
Volume15
Issue number11
DOIs
StatePublished - Jan 1 1992

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