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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 |
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| Authors: | Pier Marco Piatti Enrico Marone Manuela Mantero Emanuela Setola Elena Galluccio Pietro Lucotti Ermal Shehaj Valentina Villa Francesca Perticone Massimo Venturini Alessio Palini Flavio Airoldi Ezio Faglia Alessandro Del Maschio Antonio Colombo Roberto Chiesa Emanuele Bosi Lucilla D. Monti |
| Affiliation: | 1. Cardio-Metabolism and Clinical Trials Unit, Department of Internal Medicine and Metabolic and Cardiovascular Science Division, San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy 2. Vascular Surgery Division, Cardio-Thoraco-Vascular Department and Cardiovascular Science Division, San Raffaele Scientific Institute, Milan, Italy 3. Cardiovascular Department, Multimedica IRCCS, Milan, Italy 4. Cardio-Diabetes and Core Lab Unit, Department of Internal Medicine and Metabolic and Cardiovascular Science Division, San Raffaele Scientific Institute, Milan, Italy 6. Department of Radiology and Center for Experimental Imaging, San Raffaele Scientific Institute, Milan, Italy 7. Flow Cytometry Resource Laboratory, San Raffaele Scientific Institute, Milan, Italy 5. Interventional Cardiology Division, Cardio-Thoraco-Vascular Department and Metabolic and Cardiovascular Science Division, San Raffaele Scientific Institute, Milan, Italy |
| 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 CD34+KDR+ 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 CD34+KDR+ were higher in rs753482AA (166.2 ± 154.0 × 106 events) than in rs753482AC+CC (63.1 ± 26.9 × 106 events, p < 0.01). At the end of the study, the highest circulating CD34+KDR+ were found in IIT rs753482AA (246.9 ± 194.0 × 106 events) while the lowest levels were found in SC rs753482AC+CC (70.9 ± 45.0 × 106 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. |
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