Status:
TERMINATED
Normalization of Fasting Glucose and the Incidence of Restenosis After Peripheral Angioplasty
Lead Sponsor:
IRCCS San Raffaele
Conditions:
Type 2 Diabetes Mellitus
Peripheral Vascular Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief 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 i...
Detailed Description
The principal objectives of this project are: Objectives Primary Objectives To determine the role of fasting normoglycemia achieved with long term (6 months) intensified insulin therapy in: * Reduc...
Eligibility Criteria
Inclusion
- Both genders
- Age between 30 and 75 years
- Early type 2 diabetes, defined as FPG \>7.0 mmol/l or a PPG of 11.1 mmol/l or greater or a previous diagnosis of diabetes
- Treatments accepted
- Diet without pharmacological treatment
- One or more oral antidiabetic drug (OAD: sulfonylureas, biguanides, meglitinides) at half-maximum dose or greater
- Once daily insulin and OAD
- Angiographic documentation of infrapopliteal arterial disease (stenosis \>70% or occlusion)
- Critical limb ischemia (CLI) defined as
- Persistent, recurring rest pain requiring analgesia and an ankle systolic pressure \<50 mm Hg and/or toe systolic pressure \<30 mm Hg or TcPO2 \<30 mm Hg
- Ulceration, gangrene, or nonhealing wounds of the foot with ankle systolic pressure \<50 mm Hg or toe systolic pressure \<30 mm Hg or TcPO2 \<30 mm Hg
- Fontaine stages III-IV and rutherford categories IV-VI
- Lifestyle-limiting claudication defined as Rutherford category II to III associated with jeopardized single vessel runoff or complete trifurcation vessel occlusion.
- Subject able to provide a signed and dated written informed consent
Exclusion
- Type 1 diabetes, defined as positivity for GAD antibodies measured by radiobinding assay
- Unwilling to inject insulin or to perform a correct self monitoring of blood glucose
- Acute limb ischemia
- Buerger disease
- Severe contrast allergy
- Hypersensitivity to aspirin and/or clopidogrel
- Systemic coagulopathy contraindicating antiaggregation therapy
- Hypercoagulation disorder
- Serum creatinine\>2.0 mg/dl at screening
- Active liver disease, or ALT or AST \>2.5 times upper limit of normal at screening
- Chronic or recurrent treatment with systemic corticosteroids
- Malignant diseases
- Psychiatric diseases which make participation impossible
- Alcohol abuse
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01150617
Start Date
December 1 2008
End Date
May 1 2011
Last Update
September 13 2012
Active Locations (1)
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1
Cardio-Metabolic and Clinical Trials Unit, San Raffaele Scientific Institute
Milan, Italy, 20132