Status:
COMPLETED
Endothelial Effects of Basal Insulin: Detemir Versus Glargine
Lead Sponsor:
University of Padova
Conditions:
Type 2 Diabetes
Endothelial Dysfunction
Eligibility:
All Genders
35-80 years
Phase:
PHASE4
Brief Summary
Endothelial progenitor cell (EPC) level represents a surrogate marker of cardiovascular risk and an indicator of the ongoing vascular damage. Moreover, EPCs are involved in the pathogenesis of virtual...
Detailed Description
Diabetes mellitus is associated with a strikingly high incidence of cardiovascular events. This is likely attributable to the widespread vascular damage due to uncontrolled hyperglycaemia and associat...
Eligibility Criteria
Inclusion
- Type 2 diabetes
- Macroangiopathy (coronary, or peripheral, or cerebrovascular)
- On oral antidiabetic therapy
- HbA1c \> 7.0%
Exclusion
- Type 1 diabetes
- Acute diabetic decompensation
- Use of glitazones
- Cancer
- Acute disease or infection
- Chronic renal failure (serum creatinin \> 2.0 mg/dl)
- Advanced liver disease (Child B-C)
- Immune disease, organ transplantation, immunosuppression
- Recent surgery (within 3 months)
- Recent cardiovascular events (within 3 months)
- Inability to provide informed consent
- Pregnancy and lactation
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00699686
Start Date
May 1 2008
End Date
March 1 2010
Last Update
August 17 2010
Active Locations (1)
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1
Dipartimento di Medicina Clinica e Sperimentale, Divisione di Malattie del Metabolismo
Padua, Italy, 35100