The Effect of Nebivolol on Insulin Sensitivity

Condition(s) targeted: Hypertension

Intervention: Nebivolol (Drug); Atenolol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Imperial College London

Official(s) and/or principal investigator(s):
Neil R Poulter, Principal Investigator, Affiliation: Imperial College London

Overall contact:
Sarah L Wilson, BN MSc PhD, Phone: 020 7594 3423

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.

Official title: A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Difference in insulin sensitivity

Secondary outcome:

Difference in 24 hour blood pressure

Difference in cholesterol

Difference in HbA1c

Difference in body weight

Difference in FEV1

Difference in wellbeing

Difference in cerebral blood flow

Detailed 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females of any age

- Blood pressure that meets any of the three following criteria:

- Systolic blood pressure (SBP) <= 160 and diastolic blood pressure (DBP) <= 90 on

one antihypertensive drug; OR

- SBP <= 140 and DBP <= 85 on two antihypertensive drugs; OR

- SBP 140-170 and DBP 90-100 on no antihypertensive drugs.

Exclusion Criteria:

- Compelling indication for treatment with a beta blocker

- Contraindication to, or previous history of, major intolerance to treatment with a

beta blocker or thiazide-like diuretic

- Any condition that will interfere with the treatment or the patient's ability to

complete the study

Sarah L Wilson, BN MSc PhD, Phone: 020 7594 3423

Imperial College London, Paddington, London W2 1PG, United Kingdom; Recruiting
Sarah L Wilson, BN MSc PhD, Phone: 020 7594 3423
Sarah L Wilson, BN MSc PhD, Sub-Investigator

Starting date: July 2006
Last updated: April 25, 2007