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Effect of Normalization of Fasting Glucose by Intensified Insulin Therapy on the Incidence of Restenosis After Peripheral Angioplasty in Patients With Type 2 Diabetes. (LIMBISCH)
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.
Details
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 46 |
| Start date | 2008-12 |
| Completion | 2011-05 |
Conditions
- Type 2 Diabetes Mellitus
- Peripheral Vascular Disease
Interventions
- Insulin glargine plus insulin analogues
Primary outcomes
- Reduction of restenosis after peripheral angioplasty — 6 months, average up to 30 weeks
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.
Countries
Italy