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The Effect of Nebivolol on Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT00125853
Recruitment Status : Completed
First Posted : August 2, 2005
Last Update Posted : April 8, 2014
Sponsor:
Collaborator:
Foundation for Circulatory Health
Information provided by (Responsible Party):
Imperial College London

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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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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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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Ages Eligible for Study:   Child, Adult, Older Adult
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125853


Locations
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United Kingdom
Imperial College London
Paddington, London, United Kingdom, W2 1PG
Sponsors and Collaborators
Imperial College London
Foundation for Circulatory Health
Investigators
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Principal Investigator: Neil R Poulter Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00125853     History of Changes
Other Study ID Numbers: NPSW02
First Posted: August 2, 2005    Key Record Dates
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:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Atenolol
Nebivolol
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