Comparison of Blood Pressure Medications on Metabolism

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642434
• Other study ID #: UNM04094
• Status: Completed
• Phase: Phase 4
• Start date: January 2004
• Est. completion date: July 2008

Study information

• Verified date: December 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• not enrolling

Exclusion Criteria:

• not enrolling

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Drug:
• carvedilol
variable
• metoprolol
variable

Locations

Country	Name	City	State
United States	UNMHSC	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):146-15

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	5 months