A Phase 4 interventional study of carvedilol and metoprolol in Diabetes, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-12-26.
Sponsored by University of New Mexico · Phase 4, Interventional, and Diagnostic
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
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
study drug- carvedilol
Drug: carvedilol
study drug metorprolol
Drug: metoprolol
variable
Also known as: coreg, toprol
variable
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
| Milestone | Metoprolol | Carvedilol |
|---|---|---|
| Started | 10 | 12 |
| Number of participants treated | 10 | 12 |
| Completed | 10 | 12 |
| Not completed | 0 | 0 |
Reporting the number of participants with a change in markers of inflammation (PAI-1) following treatment compared to baseline.
| participants | Metoprolol | Carvedilol |
|---|---|---|
| Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline | 0 | 0 |
Collected over PI left institution and study withdrawn.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Metoprolol | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Carvedilol | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Number of Participants Treated With Metoprolol | Number of Participants Treated With Carvedilol | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 11 | 20 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Number of Participants Treated With Metoprolol | Number of Participants Treated With Carvedilol | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of New Mexico