Capillary loss and leakage after five years of intensified insulin treatment in patients with insulin-dependent diabetes mellitus.

Ninety-six patients with insulin-dependent diabetes mellitus were randomized to intensified conventional treatment (n = 44) or regular treatment (n = 52) programs and followed for 5 years. Hemoglobin A1c was reduced from 9.5% +/- 0.1% to 7.2% +/- 0.1% in the intensified conventional treatment group and from 9.4% +/- 0.2% to 8.7% +/- 0.1% in the regular treatment group (mean +/- standard error) (P less than 0.001). Capillary loss and leakage of fluorescein as evaluated with fluorescein angiography increased significantly in the regular treatment group (P less than 0.05; P less than 0.01) but not in the intensified conventional treatment group. Capillary loss (P less than 0.01) and leakage (P less than 0.001) were related to metabolic control as measured by Hb A1c but not to duration of diabetes or smoking habits. Capillary loss (P less than 0.05) but not leakage was related to the initial diastolic blood pressure.

RCT Entities:   Population Interventions Outcomes