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Sponsors and Collaborators: |
Kaleida Health GlaxoSmithKline |
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Information provided by: | Kaleida Health |
ClinicalTrials.gov Identifier: | NCT00430040 |
To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by suppressing free radicals(charged substances that cause damage to the body ) and inflammation.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 Hypertension |
Drug: Carvedilol Drug: Lisinopril Drug: Hydrochlorothiazide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI:Effects on Oxidative Stress and Inflammation. |
Estimated Enrollment: | 60 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | May 2008 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Barb Hall, LPN | 716-887-5104 | bhall@kaleidahealth.org |
Contact: Prabhakar Viswanathan, MD, PhD | 716-887-5104 | pviswanathan@kaleidahealth.org |
United States, New York | |
Diabetes - Endocrinology Center of Western New York | |
Buffalo, New York, United States, 14209 |
Principal Investigator: | Paresh Dandona, MD, PhD | Kaleida Health / University at Buffalo |
Study ID Numbers: | 1918 |
Study First Received: | January 30, 2007 |
Last Updated: | January 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00430040 History of Changes |
Health Authority: | United States: Institutional Review Board |
Type 2 Diabetes Mellitus Hypertension Carvedilol CR Beta-blocker |
Oxidative stress Inflammation Vascular benefits |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Diuretics Sodium Chloride Symporter Inhibitors Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Metabolic Disorder Carvedilol Metabolic Diseases Lisinopril Vascular Diseases Diabetes Mellitus |
Endocrine System Diseases Stress Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Hydrochlorothiazide Protease Inhibitors Inflammation Diabetes Mellitus, Type 2 Adrenergic Antagonists Endocrinopathy Glucose Metabolism Disorders Hypertension |
Vasodilator Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cardiotonic Agents Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Adrenergic beta-Antagonists Cardiovascular Diseases Carvedilol Metabolic Diseases |
Lisinopril Vascular Diseases Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Adrenergic alpha-Antagonists Cardiovascular Agents Antihypertensive Agents Protective Agents Hydrochlorothiazide Pharmacologic Actions Protease Inhibitors Natriuretic Agents Diabetes Mellitus, Type 2 Adrenergic Antagonists |