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Sponsored by: |
University of Padova |
Information provided by: | University of Padova |
ClinicalTrials.gov Identifier: | NCT00699686 |
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 virtually all diabetic complications. Therefore, ways to modulate EPCs are currently considered of utmost importance, especially in high-risk subjects. While many drugs with pleiotropic vasculoprotective effects have shown ability to positively modulate EPCs, there is no data on the effects of specific insulin formulations.
This is a human randomised cross-over comparison trial. The purpose is to compare the effects of two basal insulin analogues (detemir and glargine) added to oral antidiabetic therapy in poorly-controlled type 2 patients with cardiovascular disease on endothelial function and EPC levels.
The aim is to identify significant differences between the two basal insulin analogues in terms of endothelial function and EPC levels, in relation with metabolic control (HbA1c) and change in body weight during the treatment period.
As EPC level is the most innovative outcome measure of this study and represents the primary endpoint, variation in EPC levels during treatment with either insulin will be correlated with changes in HbA1c and weight gain, as explanatory variables. Endothelial dysfunction/damage, measured evaluated using soluble markers, will be the secondary outcome. Given the supposed inverse correlation between EPC and endothelial damage, it is expected that EPC increase reflects amelioration in endothelial biology, a result that may have significant clinical implications in this cohort of high-risk patients.
Condition | Intervention | Phase |
Type 2 Diabetes Endothelial Dysfunction Cardiovascular Disease |
Drug: Glargine Drug: Detemir |
Phase IV |
MedlinePlus related topics: | Diabetes |
ChemIDplus related topics: | Insulin Insulin glargine Insulin Detemir |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | Effects of Adding Basal Insulin on Endothelial Progenitor Cell Levels in Poorly-Controlled Type 2 Diabetic Patients With Cardiovascular Disease. A Randomized Cross-Over Study Comparing Insulin Detemir and Glargine |
Estimated Enrollment: | 50 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Glargine: Active Comparator
During this arm/phase patients take subcutaneous glargine daily for 3 months.
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Drug: Glargine
Daily bedtime subcutaneous insulin Glargine in individualized doses.
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Detemir: Experimental
During this arm/phase, patients take insulin Detemir subcutaneously for 3 months.
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Drug: Detemir
Daily bedtime subcutaneous insulin Detemir in individualized doses.
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Show Detailed Description |
Ages Eligible for Study: | 35 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Angelo Avogaro, M.D. Ph.D | 39-049-821-2178 | angelo.avogaro@unipd.it |
Contact: Gian Paolo Fadini, M.D. | 39-049-821-2185 | gianpaolo.fadini@unipd.it |
Italy | |||||
Dipartimento di Medicina Clinica e Sperimentale, Divisione di Malattie del Metabolismo | Recruiting | ||||
Padova, Italy, 35100 | |||||
Principal Investigator: Angelo Avogaro, M.D. Ph.D |
University of Padova |
Principal Investigator: | Angelo Avogaro, M.D. | University of Padova, Medical School |
Responsible Party: | University of Padova, Medical School ( Angelo Avogaro ) |
Study ID Numbers: | LIBRA |
First Received: | June 17, 2008 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00699686 |
Health Authority: | Italy: Institutional Review Board; Italy: Ministry of Health |
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