Normalization of Fasting Glucose and the Incidence of Restenosis After Peripheral Angioplasty
Status:
Terminated
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
Primary objective of the study is to test whether an intensified insulin therapy
incorporating the target of normal fasting glucose (<5.5 mmol/L) and glycated hemoglobin
<6.5% is able to halve the incidence of angiographic restenosis at 6 months (expected rate
45%, to be reduced at 15%) after peripheral angioplasty compared with standard care to
achieve a glycated hemoglobin <7.0% in patients with type 2 diabetes and limb ischemia.
Secondary objectives include the identification of markers associated with, and predictive
of, restenosis and the investigation of the underlying pathophysiological background, with
specific focus on the role of nitric oxide (NO), mechanisms of endothelial
activation/apoptosis, inflammation and matrix remodeling risk profiles, candidate gene
polymorphisms and endothelial progenitor cells evaluation.
Methodology: This is a randomized, open-label, clinical trial comparing two regimens of
insulin therapy having as an outcome measure the incidence of angiographic restenosis at 6
months after peripheral angioplasty. Seventy consecutive patients with type 2 diabetes and
peripheral arterial disease undergoing peripheral angiography and subsequent angioplastic
procedure will be studied. Patients will be treated by intensive insulin therapy, based on
three pre-prandial administrations of regular insulin or short acting insulin analogues
combined with the long-acting insulin analogue glargine or standard care based on once-daily
insulin and oral antidiabetics agents. Patients randomized to the intensive insulin therapy
arm will be educated and followed up with daily measurements of fasting glucose and weekly
phone contacts with the target of fasting glucose <5.5 mmol/L (99 mg/dl) to obtain glycated
hemoglobin <6.5%. The control arm will be followed to achieve a target of glycated hemoglobin
<7.0%. Life style recommendations, including diet and physical activity program, will be the
same for the two arms. All patients will undergo three visits with physical examination and
blood sampling, at baseline and at 2, 4 and 6 months after angioplasty. Moreover, patients on
normal fasting glucose arm will be monitored by phone on weekly basis in order to test their
adherence to therapeutic target.