Clinical trial NCT00125853: The Effect of Nebivolol on Insulin Sensitivity
Official title: A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: blood pressure
insulin sensitivity
beta blockers
randomised double blind crossover trial
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Foundation for Circulatory Health
First posted: 2005-08-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin Sensitivity Index (ISI)
timeFrame: Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment
Secondary outcomes:
measure: 24 Hour Systolic Blood Pressure
timeFrame: Before and after 8 weeks of treatment
measure: Total Cholesterol
timeFrame: Before and after 8 weeks of treatment
measure: HbA1c
timeFrame: Before and after 8 weeks of treatment
measure: BMI
timeFrame: Before and after 8 weeks of treatment
Other outcomes:
Locations:
city: Paddington
country: United Kingdom
facility: Imperial College London
state: London
Study officials:
affiliation: Imperial College London
name: Neil R Poulter
role: PRINCIPAL_INVESTIGATOR
References: