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The Effect of Nebivolol on Insulin Sensitivity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Foundation for Circulatory Health
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00125853
First received: July 29, 2005
Last updated: April 25, 2007
Last verified: April 2007
History of Changes
  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
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:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Difference in insulin sensitivity

Secondary Outcome Measures:
  • Difference in 24 hour blood pressure
  • Difference in cholesterol
  • Difference in HbA1c
  • Difference in body weight
  • Difference in FEV1
  • Difference in wellbeing
  • Difference in cerebral blood flow

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Study Completion Date: January 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125853

Contacts
Contact: Sarah L Wilson, BN MSc PhD 020 7594 3423

Locations
United Kingdom
Imperial College London Recruiting
Paddington, London, United Kingdom, W2 1PG
Contact: Sarah L Wilson, BN MSc PhD     020 7594 3423        
Sub-Investigator: Sarah L Wilson, BN MSc PhD            
Sponsors and Collaborators
Imperial College London
Foundation for Circulatory Health
Investigators
Principal Investigator: Neil R Poulter Imperial College London
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00125853     History of Changes
Other Study ID Numbers: NPSW02
Study First Received: July 29, 2005
Last Updated: April 25, 2007
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
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Atenolol
Nebivolol
Insulin
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 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
Hypoglycemic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on June 18, 2013