The Effect of Nebivolol on Insulin Sensitivity

Imperial College London

Status: Completed

Conditions: Hypertension

Treatments: Drug: Nebivolol; Drug: Atenolol

Study type: Interventional

Funder types: Other

Identifiers

NCT00125853

NPSW02

Details and patient eligibility

About

The purpose of this study is to conduct a randomised trial to compare the insulin sensitivity, 24 hour blood pressure profile, and tolerability of nebivolol plus a thiazide-like diuretic versus atenolol plus a thiazide-like diuretic.

Full description

Retrospective studies of treated hypertensive cohorts have strongly implicated beta blocker therapy as increasing the risk of developing new-onset diabetes. This has led to the latest British Hypertension Society guidelines advising caution when using beta blockers particularly in combination with thiazide-like diuretics. However the National Institute of Clinical Excellence recommends beta-blocker + thiazide combinations as the treatment of choice in patients who are not at increased risk of developing diabetes. Nebivolol is a newer class of beta blocker. Some studies in diabetic hypertensive patients have suggested that nebivolol does not impair insulin sensitivity. The aim of this study is to compare the effect on insulin sensitivity of nebivolol versus atenolol, both in combination with a thiazide-like diuretic, in a group of non-diabetic hypertensive patients.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females aged 18 or above
• Blood pressure that meets any of the three following criteria:
• BP should be <140/85 mmHg on a maximum of two anti-hypertensive drugs

Exclusion criteria

• contraindications to beta-blockade
• contraindications to thiazide use
• if there was a history of asthma, diabetes, heart failure, bradycardia, atrial fibrillation, AV conduction disturbances
• concurrent treatment with verapamil & dilitiazem
• childbearing women
• compelling indication for treatment with a beta blocker
• any condition that will interfere with the treatment or the patient's ability to complete the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

54 participants in 2 patient groups

atenolol 25mg daily

Experimental group

Description:

atenolol 25mg daily

Treatment:

Drug: Atenolol

nebivolol 2.5mg daily

Active Comparator group

Description:

nebivolol 2.5mg daily

Treatment:

Drug: Nebivolol