Trial Outcomes & Findings for The Effect of Nebivolol on Insulin Sensitivity (NCT NCT00125853)

Results Overview

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 Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load.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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment

Results posted on

2019-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	First is Atenolol Followed by Nebivolol (AN) Atenolol 25mg daily for 8 weeks, followed by a 4-week wash-out period, then nebivolol 2.5 mg daily for 8 weeks	First is Nebivolol Followed by Atenolol (NA) Nebivolol 2.5mg daily for 8 weeks, followed by a 4-week wash-out period, then atenolol 25 mg daily for 8 weeks
Wash-out (4 Weeks) STARTED	27	27
Wash-out (4 Weeks) COMPLETED	24	20
Wash-out (4 Weeks) NOT COMPLETED	3	7
First Intervention (8 Weeks) STARTED	27	27
First Intervention (8 Weeks) COMPLETED	27	27
First Intervention (8 Weeks) NOT COMPLETED	0	0
Second Intervention (8 Weeks) STARTED	24	20
Second Intervention (8 Weeks) COMPLETED	24	20
Second Intervention (8 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	First is Atenolol Followed by Nebivolol (AN) Atenolol 25mg daily for 8 weeks, followed by a 4-week wash-out period, then nebivolol 2.5 mg daily for 8 weeks	First is Nebivolol Followed by Atenolol (NA) Nebivolol 2.5mg daily for 8 weeks, followed by a 4-week wash-out period, then atenolol 25 mg daily for 8 weeks
Wash-out (4 Weeks) Lost to Follow-up	3	7

Baseline Characteristics

The Effect of Nebivolol on Insulin Sensitivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=54 Participants Crossover study design all participants will receive both treatments
Age, Continuous	61.1 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
BMI	27.2 kg/m^2 STANDARD_DEVIATION 6.7 • n=5 Participants
Current Smoker	14 Participants n=5 Participants
Ex-smoker	14 Participants n=5 Participants
Systolic Blood Pressure (SBP)	129.4 mmHg STANDARD_DEVIATION 13.2 • n=5 Participants
Diastolic Blood Pressure (DBP)	81.3 mmHg STANDARD_DEVIATION 9.0 • n=5 Participants
Heart Rate	71.1 bpm STANDARD_DEVIATION 8.9 • n=5 Participants
HBa1c	5.7 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.7 • n=5 Participants
Total Cholesterol	5.1 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Atenolol n=44 Participants Participants received Atenolol 25mg daily for 8 weeks	Nebivolol n=44 Participants Participants received Nebivolol 2.5mg daily for 8 weeks
Insulin Sensitivity Index (ISI) Before	82.36 factor Interval 50.8 to 116.9	80.70 factor Interval 52.6 to 114.7
Insulin Sensitivity Index (ISI) After	75.47 factor Interval 50.6 to 144.9	81.54 factor Interval 50.9 to 114.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Atenolol n=44 Participants Participants received Atenolol 25mg daily for 8 weeks	Nebivolol n=44 Participants Participants received Nebivolol 2.5mg daily for 8 weeks
24 Hour Systolic Blood Pressure SBP before	128.4 mmHg Standard Deviation 9.7	130.4 mmHg Standard Deviation 9.5
24 Hour Systolic Blood Pressure SBP after	117.2 mmHg Standard Deviation 9.2	121.2 mmHg Standard Deviation 8.2

SECONDARY outcome

Timeframe: Before and after 8 weeks of treatment

Fasting blood samples were taken at the beginning and end of each treatment period.

Outcome measures

Outcome measures
Measure	Atenolol n=44 Participants Participants received Atenolol 25mg daily for 8 weeks	Nebivolol n=44 Participants Participants received Nebivolol 2.5mg daily for 8 weeks
Total Cholesterol Before	5.0 mmol/L Standard Deviation 1.0	5.1 mmol/L Standard Deviation 0.9
Total Cholesterol After	4.9 mmol/L Standard Deviation 1.0	5.1 mmol/L Standard Deviation 0.9

SECONDARY outcome

Timeframe: Before and after 8 weeks of treatment

Fasting blood samples were taken at the beginning and end of each treatment period.

Outcome measures

Outcome measures
Measure	Atenolol n=44 Participants Participants received Atenolol 25mg daily for 8 weeks	Nebivolol n=44 Participants Participants received Nebivolol 2.5mg daily for 8 weeks
HbA1c Before	5.7 percentage of glycosylated hemoglobin Standard Deviation 0.8	5.7 percentage of glycosylated hemoglobin Standard Deviation 0.8
HbA1c After	5.7 percentage of glycosylated hemoglobin Standard Deviation 0.4	5.7 percentage of glycosylated hemoglobin Standard Deviation 0.3

SECONDARY outcome

Timeframe: Before and after 8 weeks of treatment

Body weights and heights were taken at the beginning and end of each treatment period.

Outcome measures

Outcome measures
Measure	Atenolol n=44 Participants Participants received Atenolol 25mg daily for 8 weeks	Nebivolol n=44 Participants Participants received Nebivolol 2.5mg daily for 8 weeks
BMI Before	28.1 kg/m^2 Standard Deviation 4.6	28.2 kg/m^2 Standard Deviation 4.7
BMI After	28.0 kg/m^2 Standard Deviation 4.4	28.3 kg/m^2 Standard Deviation 4.7

Adverse Events

Atenolol 25mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nebivolol 2.5mg Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Neil Poulter

Imperial College London

Phone: +44 2075943445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place