Trial Outcomes & Findings for Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI. (NCT NCT00430040)

NCT ID: NCT00430040

Last Updated: 2024-04-16

Results Overview

Percent change from baseline in Brachial artery vascular reactivity at 6 months calculated as: (brachial reactivity at 6 months-brachial reactivity at 0 months)/brachial reactivity at 0 month \*100

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-04-16

Participant Flow

Participant milestones

Measure	Carvedilol carvedilol Experimental arm carvedilol CR (controlled release) added to Lisinopril Doses titrated to maintain optimal blood pressure.	Lisinopril lisinopril control arm Lisinopril dose titrated to maintain optimal blood pressure.
Overall Study STARTED	7	7
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI.

Baseline characteristics by cohort

Measure	Carvedilol n=7 Participants carvedilol carvedilol: carvedilol	Lisinopril n=7 Participants lisinopril lisinopril: lisinopril	Total n=14 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 10 • n=93 Participants	59 years STANDARD_DEVIATION 11 • n=4 Participants	57 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Body mass index (BMI)	35 Kg/m^2 STANDARD_DEVIATION 3 • n=93 Participants	36 Kg/m^2 STANDARD_DEVIATION 4 • n=4 Participants	35 Kg/m^2 STANDARD_DEVIATION 3 • n=27 Participants
systolic blood pressure	134 mmHg STANDARD_DEVIATION 8 • n=93 Participants	137 mmHg STANDARD_DEVIATION 7 • n=4 Participants	136 mmHg STANDARD_DEVIATION 7 • n=27 Participants
diastolic blood pressure	88 mmHg STANDARD_DEVIATION 5 • n=93 Participants	89 mmHg STANDARD_DEVIATION 5 • n=4 Participants	89 mmHg STANDARD_DEVIATION 4 • n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Percent change from baseline in Brachial artery vascular reactivity at 6 months calculated as: (brachial reactivity at 6 months-brachial reactivity at 0 months)/brachial reactivity at 0 month *100

Outcome measures

Measure	Carvedilol n=5 Participants carvedilol carvedilol: carvedilol	Lisinopril n=6 Participants lisinopril lisinopril: lisinopril
Change in Brachial Artery Vascular Reactivity	28 percentage of change Standard Error 20	19 percentage of change Standard Error 17

SECONDARY outcome

Timeframe: 6 months

Percent change from baseline in Reactive Oxygen species (ROS) generation in MNC at 6 months calculated as: (ROS at 6 months-ROS at 0 months)/ROS at 0 month *100

Outcome measures

Measure	Carvedilol n=5 Participants carvedilol carvedilol: carvedilol	Lisinopril n=6 Participants lisinopril lisinopril: lisinopril
Change in Oxidative Stress in Mononuclear Cells (MNC)	-15 percentage of change Standard Error 9	-10 percentage of change Standard Error 11

Adverse Events

Carvedilol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lisinopril

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paresh Dandona

State University of NY at Buffalo

Phone: 7165351852

Email: dandona@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place