NCT00430040

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

Vascular Benefits of Adding CarvedilolCR to Type2 Diabetic Patients on ACEI:Effects on Oxidative Stress and Inflammation.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To determine whether addition of Carvedilol CR to diabetic patients with hypertension who are receiving the ACEi,Lisinopril,will provide added benefits to blood vessels when compared to treatment with Lisinopril alone.It is believed that carvedilol provides added benefits by suppressing free radicals(charged substances that cause damage to the body ) and inflammation.

Detailed description

Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.Both vascular oxidative stress and inflammation are CVD risk factors and impact endothelial function. Carvedilol has been demonstrated in preclinical and clinical studies (although limited in size) to exert anti-inflammatory and antioxidant properties: (1) reduce the inflammation markers such as high sensitivity C-reactive protein (hsCRP); (2) reduce oxidative stress via dually eliminating existing reactive oxygen species (ROS) and suppressing the generation of ROS; (3) prevent lipid peroxidation in myocardial cell membrane; (4) protect endothelial and vascular muscle cells from oxygen radical-mediated injury. This project is about studying the effect of carvedilol CR on blood vessels of diabetic hypertensive patients as compared to Lisinopril alone. This study involves weaning patient off their current antihypertensive medications and starting them on Lisinopril with Carvedilol CR or lisinopril alone for 6 months and studying the effects of the drugs during this period and thereafter.

Conditions

• Diabetes Mellitus, Type 2
• Hypertension

Interventions

Type	Name	Description
DRUG	Carvedilol Controlled Release (CR)	lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study. Initial dose: Carvedilol CR (20 mg QD, dose level 1) Titration: If tolerated, increase the dosage to 20 mg QD, 40 mg QD, and 80mg QD orally over successive intervals of at least 2 weeks to achieve target blood pressure sSBP \<130 and sDBP \< 80
DRUG	lisinopril	lisinopril starting dose in all patients 10 mg QD for 1 week then increase to 20 mg QD throughout the study

Timeline

• Start date: 2007-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2007-02-01
• Last updated: 2024-04-16
• Results posted: 2024-04-16

Locations

1 site across 1 country: United States