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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Nebivolol
Drug: Atenolol
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title First is Atenolol Followed by Nebivolol (AN) First is Nebivolol Followed by Atenolol (NA)
Hide Arm/Group Description Atenolol 25mg daily for 8 weeks, followed by a 4-week wash-out period, then nebivolol 2.5 mg daily for 8 weeks Nebivolol 2.5mg daily for 8 weeks, followed by a 4-week wash-out period, then atenolol 25 mg daily for 8 weeks
Period Title: Wash-out (4 Weeks)
Started 27 27
Completed 27 27
Not Completed 0 0
Period Title: First Intervention (8 Weeks)
Started 27 27
Completed 27 27
Not Completed 0 0
Period Title: Wash-out (4 Weeks)
Started 27 27
Completed 24 20
Not Completed 3 7
Reason Not Completed
Lost to Follow-up             3             7
Period Title: Second Intervention (8 Weeks)
Started 24 20
Completed 24 20
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description Crossover study design all participants will receive both treatments
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants
61.1  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
29
  53.7%
Male
25
  46.3%
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 54 participants
27.2  (6.7)
[1]
Measure Description: kg/m2
Current Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
14
  25.9%
Ex-smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
14
  25.9%
Systolic Blood Pressure (SBP)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 54 participants
129.4  (13.2)
Diastolic Blood Pressure (DBP)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 54 participants
81.3  (9.0)
Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Bpm
Number Analyzed 54 participants
71.1  (8.9)
HBa1c  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated hemoglobin
Number Analyzed 54 participants
5.7  (0.7)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 54 participants
5.1  (1.0)
1.Primary Outcome
Title Insulin Sensitivity Index (ISI)
Hide Description

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.

Time Frame Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with mild-to-moderate essential hypertension, aged 18 years or above, with blood pressure controlled to <140/85 mmHg on a maximum of two antihypertensive drugs, were recruited from the Peart-Rose Hypertension clinic at St Mary's Hospital in West London and from local general practices.
Arm/Group Title Atenolol Nebivolol
Hide Arm/Group Description:
Participants received Atenolol 25mg daily for 8 weeks
Participants received Nebivolol 2.5mg daily for 8 weeks
Overall Number of Participants Analyzed 44 44
Mean (Inter-Quartile Range)
Unit of Measure: factor
Before
82.36
(50.8 to 116.9)
80.70
(52.6 to 114.7)
After
75.47
(50.6 to 144.9)
81.54
(50.9 to 114.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atenolol, Nebivolol
Comments Comparing treatment effects on ISI
Type of Statistical Test Other
Comments

Linear Mixed effect Modelling, adjusted for baseline values and period effect

Difference of LSMeans treatment effect (SE) = 0.05 (0.09)

Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Linear Mixed effect Modelling, adjusted
Comments [Not Specified]
2.Secondary Outcome
Title 24 Hour Systolic Blood Pressure
Hide Description 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.
Time Frame Before and after 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Nebivolol
Hide Arm/Group Description:
Participants received Atenolol 25mg daily for 8 weeks
Participants received Nebivolol 2.5mg daily for 8 weeks
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: mmHg
SBP before 128.4  (9.7) 130.4  (9.5)
SBP after 117.2  (9.2) 121.2  (8.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atenolol, Nebivolol
Comments Comparing treatment effects on ABPM
Type of Statistical Test Other
Comments

Linear Mixed effect Model, adjusted for baseline values and period effect

Difference of LSMeans treatment effect (SE)

= -2.59 (1.34)

Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Linear Mixed effect Model, adjusted for
Comments [Not Specified]
3.Secondary Outcome
Title Total Cholesterol
Hide Description Fasting blood samples were taken at the beginning and end of each treatment period.
Time Frame Before and after 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Nebivolol
Hide Arm/Group Description:
Participants received Atenolol 25mg daily for 8 weeks
Participants received Nebivolol 2.5mg daily for 8 weeks
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: mmol/L
Before 5.0  (1.0) 5.1  (0.9)
After 4.9  (1.0) 5.1  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atenolol, Nebivolol
Comments Comparing treatment effects on total cholesterol
Type of Statistical Test Other
Comments

Linear Mixed effect Model, adjusted for baseline values and period effect

Difference of LSMeans treatment effect (SE)

= -0/09 (0.14)

Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Linear Mixed effect Modelling, adjusted
Comments [Not Specified]
4.Secondary Outcome
Title HbA1c
Hide Description Fasting blood samples were taken at the beginning and end of each treatment period.
Time Frame Before and after 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Nebivolol
Hide Arm/Group Description:
Participants received Atenolol 25mg daily for 8 weeks
Participants received Nebivolol 2.5mg daily for 8 weeks
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated hemoglobin
Before 5.7  (0.8) 5.7  (0.8)
After 5.7  (0.4) 5.7  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atenolol, Nebivolol
Comments Comparing treatment effects on HbA1c
Type of Statistical Test Other
Comments

Linear Mixed effect Model, adjusted for baseline values and period effect

Difference of LSMeans treatment effect (SE) =0.02 (0.03)

Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Linear Mixed effect Modelling, adjusted
Comments [Not Specified]
5.Secondary Outcome
Title BMI
Hide Description Body weights and heights were taken at the beginning and end of each treatment period.
Time Frame Before and after 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol Nebivolol
Hide Arm/Group Description:
Participants received Atenolol 25mg daily for 8 weeks
Participants received Nebivolol 2.5mg daily for 8 weeks
Overall Number of Participants Analyzed 44 44
Mean (Standard Deviation)
Unit of Measure: kg/m^2
Before 28.1  (4.6) 28.2  (4.7)
After 28.0  (4.4) 28.3  (4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Atenolol, Nebivolol
Comments Comparing treatment effects on BMI
Type of Statistical Test Other
Comments

Linear Mixed effect Model, adjusted for baseline values and period effect

Difference of LSMeans treatment effect (SE)

= -0.21(0.13)

Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Linear Mixed effect Modelling, adjusted
Comments [Not Specified]
Time Frame 32 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atenolol 25mg Daily Nebivolol 2.5mg Daily
Hide Arm/Group Description

atenolol 25mg daily

Atenolol: Atenolol 25mg daily

nebivolol 2.5mg daily

Nebivolol: Nebivolol 25mg daily

All-Cause Mortality
Atenolol 25mg Daily Nebivolol 2.5mg Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/54 (0.00%) 
Hide Serious Adverse Events
Atenolol 25mg Daily Nebivolol 2.5mg Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/54 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atenolol 25mg Daily Nebivolol 2.5mg Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/54 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Neil Poulter
Organization: Imperial College London
Phone: +44 2075943445
EMail: n.poulter@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00125853    
Other Study ID Numbers: NPSW02
First Submitted: July 29, 2005
First Posted: August 2, 2005
Results First Submitted: June 12, 2019
Results First Posted: December 12, 2019
Last Update Posted: December 12, 2019