The Effect of Nebivolol on Insulin Sensitivity - Full Text View

Purpose

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	Intervention
Hypertension	Drug: Nebivolol Drug: Atenolol


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines High Blood Pressure

Drug Information available for: Insulin human Atenolol Nebivolol Nebivolol Hydrochloride

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Difference in insulin sensitivity [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference in 24 hour blood pressure [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]
Difference in cholesterol [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]
Difference in HbA1c [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]
Difference in body weight [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]
Difference in Forced Expiratory Volume 1 (FEV1) [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]
Difference in wellbeing [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]
Difference in cerebral blood flow [ Time Frame: Between baseline and 20 weeks after enrollment ] [ Designated as safety issue: No ]


Enrollment:	54
Study Start Date:	July 2006
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125853

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

No publications provided


Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00125853 History of Changes
Other Study ID Numbers:	NPSW02
Study First Received:	July 29, 2005
Last Updated:	April 7, 2014
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:


blood pressure insulin sensitivity beta blockers randomised double blind crossover trial

Additional relevant MeSH terms:


Hypertension Insulin Resistance Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Vascular Diseases Atenolol Insulin Nebivolol Adrenergic Agents Adrenergic Antagonists Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists	Anti-Arrhythmia Agents Antihypertensive Agents Autonomic Agents Cardiovascular Agents Hypoglycemic Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sympatholytics Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on February 25, 2015