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The Effect of Nebivolol on Insulin Sensitivity

NCT ID: NCT00125853

Last Updated: 2019-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Keywords

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blood pressure insulin sensitivity beta blockers randomised double blind crossover trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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atenolol 25mg daily

atenolol 25mg daily

Group Type EXPERIMENTAL

Atenolol

Intervention Type DRUG

Atenolol 25mg daily

nebivolol 2.5mg daily

nebivolol 2.5mg daily

Group Type ACTIVE_COMPARATOR

Nebivolol

Intervention Type DRUG

Nebivolol 2.5mg daily

Interventions

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Nebivolol

Nebivolol 2.5mg daily

Intervention Type DRUG

Atenolol

Atenolol 25mg daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Circulatory Health

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil R Poulter

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College London

Paddington, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NPSW02

Identifier Type: -

Identifier Source: org_study_id