OBJECTIVE - Microalbuminuria can reflect the progress of microvascular comp
lications and may be predictive of macrovascular disease in type 2 diabetes
. The effect of intensive glycemic control on microalbuminuria in patients
in the U.S. who have had type 2 diabetes for several years has not previous
ly been evaluated.
RESEARCH DESIGN AND METHODS - We randomly assigned 153 male patients to eit
her intensive treatment (INT) (goal HbA(1c) 7.1%) or to standard treatment
(ST) (goal HbA(1c) 9.1% P = 0.001), and data were obtained during a 2-year
period. Mean duration of known diabetes was 8 years, mean age of the patien
ts was 60 years, and patients were well matched at baseline. We obtained 3-
h urine samples for each patient at baseline and annually and defined micro
albuminuria as an albumin:creatinine ratio of 0.03-030. All patients were t
reated with insulin and received instructions regarding diet and exercise.
Hypertension and dyslipidemia were treated with similar goals in each group
.
RESULTS - A total of 38% of patients had microalbuminuria at entry and were
evenly assigned to both treatment groups. INT retarded the progression of
microalbuminuria during the 2-year period: the changes in albumin:creatinin
e ratio from baseline to 2 years of INT versus ST were 0.045 vs. 0.141, res
pectively (P = 0.046). Retardation of progressive urinary albumin excretion
was most pronounced in those patients who entered the study with microalbu
minuria and were randomized to INT. Patients entering with microalbuminuria
had a deterioration in creatinine clearance at 2 years regardless of the i
ntensity of glycemic control. In the group entering without microalbuminuri
a, the subgroup receiving ST had a lower percentage of patients with a macr
ovascular event (17%) than the subgroup receiving INT (36%) (P = 0.03). Use
of ACE inhibitors or calcium-channel blockers was similarly distributed am
ong the groups.
CONCLUSIONS - Intensive glycemic control retards microalbuminuria in patien
ts who have had type 2 diabetes for several years but may not lessen the pr
ogressive deterioration of glomerular function. Increases in macrovascular
event rates in the subgroup entering without albuminuria who received INT r
emain unexplained but could reflect early worsening, as observed with micro
vascular disease in the Diabetes Control and Complications Trial.