Hypertension, Type 2 Diabetes Mellitus
Conditions
Keywords
beta-blockers, endothelial function
Brief summary
The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
Detailed description
Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at improving artery health independent of their blood pressure lowering effects. Artery health will be assessed non-invasively by ultrasound. Certain markers of atherosclerosis found in the blood will also be measured.
Interventions
DRUGCarvedilol
25 mg twice daily for five months.
DRUGMetoprolol
200 mg twice daily for five months.
Sponsors
GlaxoSmithKline
St. Paul Heart Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 30-80 years old * Documented history of type 2 diabetes * Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period * Stable anti-diabetic regimen throughout the study period * Body mass index (BMI) between 22-45 kg/m2 * HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone * Screening blood pressure (BP) \> 130/80 (average of 3 sitting measurements), with current medications
Exclusion criteria
* Uncontrollable or symptomatic arrhythmias * Unstable angina * Sick sinus syndrome or second or third degree heart block * Decompensated heart failure * Myocardial infarction (MI) or stroke within 3 months of screening * Bradycardia * Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids * Bronchial asthma or related bronchospastic conditions * New onset/diagnosed type 2 diabetes (\<3 months) * Clinically significant renal or liver disease (creatinine \>2.5 mg/dL) * Endocrine disorders * Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics * Use of beta-blockers within 3 months of screening * Use of corticosteroids * Systemic disease, including cancer, with reduced life expectancy (\<12 months) * Psychological illness/condition that interferes with comprehension of study requirements * Use of an investigational drug within 30 days of entry into study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation | change from baseline to 5 months | Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion. |
Countries
United States
Participant flow
Recruitment details
Recruitment occured at medical clinics.
Participants by arm
| Arm | Count |
|---|---|
| Metoprolol Metoprolol, orally, 200mg, twice daily for five months | 19 |
| Carvedilol Carvedilol, orally, 25mg, twice daily for five months | 17 |
| Total | 36 |
Baseline characteristics
| Characteristic | Total | Metoprolol | Carvedilol |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 18 Participants | 16 Participants |
| Age, Continuous | 61.4 years STANDARD_DEVIATION 9.4 | 61.9 years STANDARD_DEVIATION 9.9 | 60.9 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 36 participants | 19 participants | 17 participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 26 Participants | 13 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 19 | 0 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 17 |
Outcome results
Primary
Flow Mediated Dilation
Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.
Time frame: change from baseline to 5 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carvedilol | Flow Mediated Dilation | 6.2 percentage of change in dilation | Standard Deviation 3.9 |
| Metoprolol | Flow Mediated Dilation | 4.1 percentage of change in dilation | Standard Deviation 3.4 |