The Effect of Nebivolol on Insulin Sensitivity

• 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: Imperial College London
• Collaborator: Foundation for Circulatory Health
• Information provided by (Responsible Party): Imperial College London

Tracking Information

• First Submitted Date: July 29, 2005
• First Posted Date: August 2, 2005
• Results First Submitted Date: June 12, 2019
• Results First Posted Date: December 12, 2019
• Last Update Posted Date: December 12, 2019
• Actual Study Start Date: July 2006
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load.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 (submitted: July 29, 2005): Difference in insulin sensitivity

Current Secondary Outcome Measures (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 (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: The Effect of Nebivolol on Insulin Sensitivity
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

• Drug: Nebivolol
  Nebivolol 2.5mg daily
• Drug: Atenolol
  Atenolol 25mg daily

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 7, 2014): 54
• Original Enrollment (submitted: July 29, 2005): 50
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00125853
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Imperial College London
• Study Sponsor: Imperial College London
• Collaborators: Foundation for Circulatory Health

Investigators

• Principal Investigator: Neil R Poulter; Imperial College London

• PRS Account: Imperial College London
• Verification Date: November 2019