Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.
Recruitment status was: Active, not recruiting
|Diabetes Mellitus, Type 2 Hypertension||Drug: carvedilol Drug: lisinopril||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI:Effects on Oxidative Stress and Inflammation.|
- Brachial artery vascular reactivity at 6 months [ Time Frame: 6 months ]Brachial artery vascular reactivity
- Oxidative stress in Mononuclear cells, serum and plasma at six months [ Time Frame: 6 months ]Oxidative stress
|Study Start Date:||February 2007|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Active Comparator: lisinopril
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.Both vascular oxidative stress and inflammation are CVD risk factors and impact endothelial function.
Carvedilol has been demonstrated in preclinical and clinical studies (although limited in size) to exert anti-inflammatory and antioxidant properties: (1) reduce the inflammation markers such as high sensitivity C-reactive protein (hsCRP); (2) reduce oxidative stress via dually eliminating existing reactive oxygen species (ROS) and suppressing the generation of ROS; (3) prevent lipid peroxidation in myocardial cell membrane; (4) protect endothelial and vascular muscle cells from oxygen radical-mediated injury.
This project is about studying the effect of carvedilol CR on blood vessels of diabetic hypertensive patients as compared to Lisinopril alone.
This study involves weaning patient off their current antihypertensive medications and starting them on Lisinopril and Carvedilol CR or placebo for 6 months and studying the effects of the drugs during this period and thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430040
|United States, New York|
|Diabetes - Endocrinology Center of Western New York|
|Buffalo, New York, United States, 14221|
|Principal Investigator:||Paresh Dandona, MD, PhD||Kaleida Health / University at Buffalo|