The Effect of Nebivolol on Insulin Sensitivity

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Nebivolol; Drug: Atenolol	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity
Study Start Date :	July 2006
Actual Primary Completion Date :	July 2008
Actual Study Completion Date :	July 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: atenolol 25mg daily; atenolol 25mg daily	Drug: Atenolol; Atenolol 25mg daily
Active Comparator: nebivolol 2.5mg daily; nebivolol 2.5mg daily	Drug: Nebivolol; Nebivolol 25mg daily

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Difference in insulin sensitivity [ Time Frame: Between baseline and 20 weeks after enrollment ]

Secondary Outcome Measures :

1. Difference in 24 hour blood pressure [ Time Frame: Between baseline and 20 weeks after enrollment ]
2. Difference in cholesterol [ Time Frame: Between baseline and 20 weeks after enrollment ]
3. Difference in HbA1c [ Time Frame: Between baseline and 20 weeks after enrollment ]
4. Difference in body weight [ Time Frame: Between baseline and 20 weeks after enrollment ]
5. Difference in Forced Expiratory Volume 1 (FEV1) [ Time Frame: Between baseline and 20 weeks after enrollment ]
6. Difference in wellbeing [ Time Frame: Between baseline and 20 weeks after enrollment ]
7. Difference in cerebral blood flow [ Time Frame: Between baseline and 20 weeks after enrollment ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
Imperial College London
Paddington, London, United Kingdom, W2 1PG

Sponsors and Collaborators

Imperial College London

Foundation for Circulatory Health

Investigators

Principal Investigator:	Neil R Poulter	Imperial College London

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00125853 History of Changes
Other Study ID Numbers:	NPSW02
First Posted:	August 2, 2005
Last Update Posted:	April 8, 2014
Last Verified:	April 2014

Keywords provided by Imperial College London:

blood pressure; insulin sensitivity; beta blockers; randomised double blind crossover trial

Additional relevant MeSH terms:

Hypersensitivity; Insulin Resistance; Immune System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Insulin; Nebivolol; Atenolol; Hypoglycemic Agents; Physiological Effects of Drugs; Antihypertensive Agents; Vasodilator Agents	Adrenergic beta-1 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Sympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists