Diabetes
Conditions
Keywords
diabetes blood pressure oxidative stress
Brief summary
The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation. Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler
Detailed description
The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation. Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler. Baseline visit will be done when subjects are off all antihypertension medications except ACEI/ARB. Following the baseline study subjects will be randomized to study drug. The dose will be titrated until goal blood pressure is reached. Add on medication will be used if needed. Subjects will then undergo a second study. The third study will take place after 5 months on treatment. Stud drug will then be stoppped and subjects will be restudied 2 weeks later
Interventions
DRUGcarvedilol
variable
DRUGmetoprolol
variable
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* not enrolling
Exclusion criteria
* not enrolling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline | 5 months | Reporting the number of participants with a change in markers of inflammation (PAI-1) following treatment compared to baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Number of Participants Treated With Metoprolol Randomized to Metoprolol | 9 |
| Number of Participants Treated With Carvedilol Radomized to Carvedilol | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | Number of Participants Treated With Metoprolol | Number of Participants Treated With Carvedilol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline
Reporting the number of participants with a change in markers of inflammation (PAI-1) following treatment compared to baseline.
Time frame: 5 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metoprolol | Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline | 0 participants |
| Carvedilol | Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline | 0 participants |