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- Title
Effect of normalization of fasting glucose by intensified insulin therapy and influence of eNOS polymorphisms on the incidence of restenosis after peripheral angioplasty in patients with type 2 diabetes: a randomized, open-label clinical trial.
- Authors
Piatti, Pier; Marone, Enrico; Mantero, Manuela; Setola, Emanuela; Galluccio, Elena; Lucotti, Pietro; Shehaj, Ermal; Villa, Valentina; Perticone, Francesca; Venturini, Massimo; Palini, Alessio; Airoldi, Flavio; Faglia, Ezio; Del Maschio, Alessandro; Colombo, Antonio; Chiesa, Roberto; Bosi, Emanuele; Monti, Lucilla
- Abstract
Primary objective was to evaluate whether an intensified insulin therapy (IIT) incorporating the target of normal fasting glucose and HbA1c levels could halve the incidence of restenosis/amputation/SCA/death at 6 months after peripheral angioplasty compared with standard care (SC) in patients with type 2 diabetes (DMT2) affected by critical limb ischemia (CLI). Forty-six consecutive patients with DMT2 and CLI were randomly assigned to a parallel, open-label study with IIT (basal-bolus glulisine + glargine administrations) or SC (glargine administration + oral antidiabetic drugs). A SNP of eNOS (rs753482-A>C) and circulating CD34 and CD34KDR progenitor cells were determined. At the end of the study, although HbA1c levels were lower in IIT than in SC (6.9 ± 1.3 % vs. 7.6 ± 1.2 %, p < 0.05), IIT did not reduce the cumulative incidence of restenosis/amputation/SCA/death (52 and 65 %, respectively, odd ratio 0.59; CI 95 %: 0.21-1.62, p = 0.59). rs753482AC+CC as compared with rs753482AA increased the cumulative incidence of restenosis/amputation/SCA/death (79 and 42 %; odd ratio 5.3; CI 95 %: 1.41-19.5, p < 0.02). Baseline CD34KDR were higher in rs753482AA (166.2 ± 154.0 × 10 events) than in rs753482AC+CC (63.1 ± 26.9 × 10 events, p < 0.01). At the end of the study, the highest circulating CD34KDR were found in IIT rs753482AA (246.9 ± 194.0 × 10 events) while the lowest levels were found in SC rs753482AC+CC (70.9 ± 45.0 × 10 events ). IIT did not decrease the cumulative incidence of restenosis/amputation/SCA/death in DMT2 and CLI patients. These patients correspond to a class of fragile subjects at high risk of cardiovascular events, and new predictors of restenosis should be contemplated, such as of eNOS polymorphism, (rs753482-A>C SNP) and circulating endothelial progenitor cells.
- Subjects
TYPE 2 diabetes treatment; INSULIN therapy; NITRIC-oxide synthases; CLINICAL trials; DISEASE incidence; ANGIOPLASTY; CORONARY restenosis; PROGENITOR cells; GENETIC polymorphisms
- Publication
Acta Diabetologica, 2013, Vol 50, Issue 3, p373
- ISSN
0940-5429
- Publication type
Article
- DOI
10.1007/s00592-012-0426-x