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| Sponsor: | Kaleida Health |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Kaleida Health |
| ClinicalTrials.gov Identifier: | NCT00430040 |
Purpose
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 |
|---|---|---|
|
Diabetes Mellitus, Type 2 Hypertension |
Drug: carvedilol Drug: lisinopril |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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. |
| Estimated Enrollment: | 60 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: carvedilol
carvedilol
|
Drug: carvedilol
carvedilol
|
|
Active Comparator: lisinopril
lisinopril
|
Drug: lisinopril
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cathy Gamel, LPN | 716-887-4486 | cgamel@kaleidahealth.org |
| Contact: Teekam Lohano, MD | 716-887-5104 | tlohano@kaleidahealth.org |
| United States, New York | |
| Diabetes - Endocrinology Center of Western New York | Recruiting |
| Buffalo, New York, United States, 14209 | |
| Contact: Cathy Gamel 716-887-4486 cgamel@kaleidahealth.org | |
| Contact: Mehul Vora, MD 716-887-5104 mvora@buffalo.edu | |
| Principal Investigator: Paresh Dandona, MD, PhD | |
| Principal Investigator: | Paresh Dandona, MD, PhD | Kaleida Health / University at Buffalo |
More Information
| Responsible Party: | Paresh Dandona, Kaleida Health |
| ClinicalTrials.gov Identifier: | NCT00430040 History of Changes |
| Other Study ID Numbers: | 1918 |
| Study First Received: | January 30, 2007 |
| Last Updated: | June 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Type 2 Diabetes Mellitus Hypertension Carvedilol CR Beta-blocker |
Oxidative stress Inflammation Vascular benefits |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hypertension Inflammation Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Carvedilol Lisinopril Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Cardiotonic Agents Protective Agents |