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The Effect of Nebivolol on Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00125853
Recruitment Status : Completed
First Posted : August 2, 2005
Results First Posted : December 12, 2019
Last Update Posted : December 12, 2019
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: Single (Participant)
Primary Purpose: Treatment
Official Title: A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity
Actual Study Start Date : July 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

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 2.5mg daily


Outcome Measures
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Primary Outcome Measures :
  1. Insulin Sensitivity Index (ISI) [ Time Frame: Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment ]

    Patients were asked to fast for a minimum of 12 hours prior to each oral glucose tolerance test (OGTT). Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load. For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing.

    For each OGTT, the Insulin Sensitivity Index (ISI) was calculated using the standard method for oral glucose tolerance testing.



Secondary Outcome Measures :
  1. 24 Hour Systolic Blood Pressure [ Time Frame: Before and after 8 weeks of treatment ]
    The 24-h Ambulatory Blood Pressure Monitoring (ABPM) was recorded at the beginning and end of each beta-blocker treatment period. BP was automatically recorded for 24 h at 30 min intervals. The time periods from 0700h to 2200h and from 2200h to 0700h were defined as daytime and night-time, respectively.

  2. Total Cholesterol [ Time Frame: Before and after 8 weeks of treatment ]
    Fasting blood samples were taken at the beginning and end of each treatment period.

  3. HbA1c [ Time Frame: Before and after 8 weeks of treatment ]
    Fasting blood samples were taken at the beginning and end of each treatment period.

  4. BMI [ Time Frame: Before and after 8 weeks of treatment ]
    Body weights and heights were taken at the beginning and end of each treatment period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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    
Other Study ID Numbers: NPSW02
First Posted: August 2, 2005    Key Record Dates
Results First Posted: December 12, 2019
Last Update Posted: December 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Atenolol
Nebivolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists