Comparison of Blood Pressure Medications on Metabolism

Phase 4

Completed

• Conditions: Diabetes
• Interventions: Drug: carvedilol; Drug: metoprolol

• Registration Number: NCT00642434
• Lead Sponsor: University of New Mexico

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

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2008-03-21
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-25
• Primary Completion: 2008-06
• Study Completion: 2008-07
• Results First Submitted: 2012-04-11
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Results First Posted: 2023-12-26
• Last Update Posted: 2023-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• not enrolling

Exclusion Criteria

• not enrolling

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	carvedilol	study drug- carvedilol
2	metoprolol	study drug metorprolol

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UNMHSC; 🇺🇸 Albuquerque, New Mexico, United States