Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.



Status:Completed
Conditions:High Blood Pressure (Hypertension), Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2007
End Date:May 2013
Contact:Cathy Gamel, LPN
Email:cgamel@kaleidahealth.org
Phone:716-887-4486

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Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI:Effects on Oxidative Stress and Inflammation.


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.


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.

Inclusion Criteria:

- Is male or female >= 18 and <= 70 years of age

- Has a documented history of type 2 diabetes mellitus for a minimum of four months
prior to the screening visit

- Has a documented history of or current presentation with Stage 1 or Stage 2
hypertension and meets one of the following criteria:

- Has controlled hypertension (sSBP <130 mmHg AND sDBP <80 mmHg) on >=2
antihypertensive medications NOTE: A combination drug containing two
antihypertensive agents represents two antihypertensive medications OR

- Has uncontrolled hypertension (sSBP >=130 and <=170 mmHg AND/OR sDBP >=80 and <=105
mmHg) on one or two antihypertensive medications OR

- Has newly diagnosed or previously untreated hypertension (sSBP >=130 and <=170 mmHg
AND/OR sDBP >=80 and <=105 mmHg

- At Randomization, sitting systolic blood pressure (sSBP) >= 130 mmHg or sitting
diastolic blood pressure (sDBP) >= 80 mmHg and sSBP <= 170 mmHg and sDBP <= 105 mmHg

- Has been on a stable dose of a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)
reductase inhibitor (statin) for a minimum of four months prior to the screening
visit

Exclusion Criteria:

- Has any clinically significant abnormality identified in the screening physical
examination, laboratory tests or electrocardiogram which, in the judgement of the
investigator, would preclude safe completion of the study

- Is female of childbearing potential

- Has any of these cardiac conditions: uncontrollable or symptomatic arrhythmias,
unstable angina, sick sinus syndrome or second or third degree heart block (unless
treated with a permanent, functioning pacemaker), bradycardia (heart rate <55 bpm),
and stroke within three months of study screening, and history of myocardial
infarction.

- Has Congestive Heart Failure NYHA (New York Heart Association) class II-IV

- Has type 1 diabetes mellitus

- Has newly diagnosed type 2 diabetes (within 4 months of screening visit)

- Has HbA1c > 8.5%

- Has the following, as it relates to subject's antidiabetic therapy:Initiated or
changed dosage or formulation of thiazolidinediones (TZDs) within 6 months of
screening visit.

- A history of acute or chronic acidosis, including diabetic ketoacidosis

- Has current clinical diagnosis of chronic obstructive pulmonary disease (COPD, e.g.,
chronic bronchitis) or asthma

- Has a history of bronchospastic disease not undergoing active therapy in whom, in the
investigator's opinion, treatment with study medication could provoke bronchospasm

- Has evidence of any of the following clinically significant diseases that could
impair the absorption, metabolism, or excretion of orally-administered medication:

- renal disease defined as estimated Glomerular Filtration Rate (eGFR) <60mL/min per
1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula below: GFR
(mL/min/1.73m2) = 186 x [Serum Creatinine (umol/L) x 0.0113]-1.154 x Age(years)-0.203
(x 0.742 if female)

- hepatic disease (i.e., ALT or AST levels greater than three times the upper limit of
normal range, history of hepatic impairment, or by clinical assessment)

- Chronic biliary disorders

- Has endocrine disorders (e.g., pheochromocytoma, active and untreated hypo or
hyperthyroidism)

- Has any known contraindication to ACE inhibitors, alpha- or beta-blocker treatment

- Has systemic disease, including cancer, with reduced (<12 months) life expectancy

- Has used an investigational drug within 30 days or 5 half-lives (whichever is longer)
preceding the first dose of study medication

- Has a history of a psychological illness or any condition that would interfere with
the subject's ability to understand or complete the requirements of the study
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