The Effect of Nebivolol on Insulin Sensitivity

This study has been completed.
Sponsor:
Collaborator:
Foundation for Circulatory Health
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00125853
First received: July 29, 2005
Last updated: April 7, 2014
Last verified: April 2014
  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:


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

Ages Eligible for Study:   Child, Adult, Senior
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

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:
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

ClinicalTrials.gov processed this record on July 21, 2016