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Completed

NCT Number: NCT00125853

The Effect of Nebivolol on Insulin Sensitivity

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London

Paddington, London, W2 1PG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug

Nebivolol 2.5mg daily

Atenolol

Drug

Atenolol 25mg daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Foundation for Circulatory Health

Registry information

Official study title

A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Aug 2, 2005
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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