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Trial record 38 of 116 for:    Atenolol

The Effect of Nebivolol on Insulin Sensitivity

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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

Tracking Information
First Submitted Date  ICMJE July 29, 2005
First Posted Date  ICMJE August 2, 2005
Results First Submitted Date  ICMJE June 12, 2019
Results First Posted Date  ICMJE December 12, 2019
Last Update Posted Date December 12, 2019
Actual Study Start Date  ICMJE July 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
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 Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load.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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2005)
Difference in insulin sensitivity
Change History Complete list of historical versions of study NCT00125853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2019)
  • 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.
  • 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.
  • HbA1c [ Time Frame: Before and after 8 weeks of treatment ]
    Fasting blood samples were taken at the beginning and end of each treatment period.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Nebivolol on Insulin Sensitivity
Official Title  ICMJE A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Nebivolol
    Nebivolol 2.5mg daily
  • Drug: Atenolol
    Atenolol 25mg daily
Study Arms  ICMJE
  • Experimental: atenolol 25mg daily
    atenolol 25mg daily
    Intervention: Drug: Atenolol
  • Active Comparator: nebivolol 2.5mg daily
    nebivolol 2.5mg daily
    Intervention: Drug: Nebivolol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2014)
54
Original Enrollment  ICMJE
 (submitted: July 29, 2005)
50
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00125853
Other Study ID Numbers  ICMJE NPSW02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Foundation for Circulatory Health
Investigators  ICMJE
Principal Investigator: Neil R Poulter Imperial College London
PRS Account Imperial College London
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP