| Trial ID: | L4256 |
| Source ID: | NCT01150617
|
| Associated Drug: |
Insulin Glargine Plus Insulin Analogues
|
| Title: |
Normalization of Fasting Glucose and the Incidence of Restenosis After Peripheral Angioplasty
|
| Acronym: |
LIMBISCH
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Peripheral Vascular Disease
|
| Interventions: |
DRUG: Insulin glargine plus insulin analogues
|
| Outcome Measures: |
Primary: Reduction of restenosis after peripheral angioplasty, 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., 6 months, average up to 30 weeks | Secondary: Identification of new peripheral markers predictive of restenosis, 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., 6 months, average up to 30 weeks
|
| Sponsor/Collaborators: |
Sponsor: IRCCS San Raffaele
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
46
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-12
|
| Completion Date: |
2011-05
|
| Results First Posted: |
|
| Last Update Posted: |
2012-09-13
|
| Locations: |
Cardio-Metabolic and Clinical Trials Unit, San Raffaele Scientific Institute, Milan, 20132, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT01150617
|
