DiabetesPhase 4NCT00642434
Comparison of Blood Pressure Medications on Metabolism
A Phase 4 study testing carvedilol and metoprolol in people with Diabetes, run by University of New Mexico at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Diabetes
- What is being tested?
- carvedilol and metoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jul 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- not enrolling
Who cannot join
- not enrolling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carvedilol vs.Metoprolol: A Comparison of Effects on Endothelial Function and Oxidative Stress in Response to Acute Hyperglycemia in Patients With Type 2 Diabetes and Hypertension
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
Read the 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
- Conditions
- Diabetes
- Being tested
- carvedilol, metoprolol
- Keywords
- diabetes blood pressure oxidative stress
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carvedilolDrug
Also called coreg, toprol
variable
metoprololDrug
variable
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | study drug- carvedilol Receives: Drug: carvedilol |
| 2 | Active comparator | study drug metorprolol Receives: Drug: metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startJan 2004
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642434
- Sponsor's protocol ID
- UNM04094
- Status last verified
- Dec 2023
- First submitted
- 21 Mar 2008
- Last updated
- 26 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Colleran K, Aguirre L, Burge MR. Carvedilol vs. metoprolol: A comparison of effects on endothelial function and oxidative stress in response to acute hyperglycemia in patients with type 2 diabetes and hypertension. Journal of Diabetes Mellitus 2(1):146-151, 2012.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carvedilol vs.Metoprolol: A Comparison of Effects on Endothelial Function and Oxidative Stress in Response to Acute Hyperglycemia in Patients With Type 2 Diabetes and Hypertension
- ClinicalTrials.gov ID
- NCT00642434
- Acronym / sponsor ID
- UNM04094
- Conditions
- Diabetes
- Keywords
- diabetes blood pressure oxidative stress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Jan 2004 (actual)
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Posted 26 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: carvedilolstudy drug- carvedilol |
| 2 | Active comparator | Drug: metoprololstudy drug metorprolol |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- not enrolling
Key exclusion criteria (1 listed)
- not enrolling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carvedilolAlso: coreg, toprolvariable | Drug | 1 |
| metoprololvariable | Drug | 2 |
Primary outcome
Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline
Time frame: 5 months
Reporting the number of participants with a change in markers of inflammation (PAI-1) following treatment compared to baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationColleran K, Aguirre L, Burge MR. Carvedilol vs. metoprolol: A comparison of effects on endothelial function and oxidative stress in response to acute hyperglycemia in patients with type 2 diabetes and hypertension. Journal of Diabetes Mellitus 2(1):146-151, 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing carvedilol and metoprolol in people with Diabetes, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Assessed for Change in Markers of Inflammation (PAI-1) Following Treatment Compared to Baseline (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.