An interventional study of Nebivolol and Atenolol in Hypertension, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-12.
Sponsored by Imperial College London · Not applicable, Interventional, and Treatment
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.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 54 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
atenolol 25mg daily
Drug: Atenolol
nebivolol 2.5mg daily
Drug: Nebivolol
Insulin Sensitivity Index (ISI)
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 Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load.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
24 Hour Systolic Blood Pressure
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
Total Cholesterol
Fasting blood samples were taken at the beginning and end of each treatment period.
Time frame: Before and after 8 weeks of treatment
HbA1c
Fasting blood samples were taken at the beginning and end of each treatment period.
Time frame: Before and after 8 weeks of treatment
BMI
Body weights and heights were taken at the beginning and end of each treatment period.
Time frame: Before and after 8 weeks of treatment
| Milestone | First is Atenolol Followed by Nebivolol (AN) | First is Nebivolol Followed by Atenolol (NA) |
|---|---|---|
| Started | 27 | 27 |
| Completed | 27 | 27 |
| Not completed | 0 | 0 |
| Milestone | First is Atenolol Followed by Nebivolol (AN) | First is Nebivolol Followed by Atenolol (NA) |
|---|---|---|
| Started | 27 | 27 |
| Completed | 27 | 27 |
| Not completed | 0 | 0 |
| Milestone | First is Atenolol Followed by Nebivolol (AN) | First is Nebivolol Followed by Atenolol (NA) |
|---|---|---|
| Started | 27 | 27 |
| Completed | 24 | 20 |
| Not completed | 3 | 7 |
| Withdrew: Lost to follow-up | 3 | 7 |
| Milestone | First is Atenolol Followed by Nebivolol (AN) | First is Nebivolol Followed by Atenolol (NA) |
|---|---|---|
| Started | 24 | 20 |
| Completed | 24 | 20 |
| Not completed | 0 | 0 |
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.
| factor | Atenolol | Nebivolol |
|---|---|---|
| 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) |
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.
| mmHg | Atenolol | Nebivolol |
|---|---|---|
| SBP before | 128.4 ± 9.7 | 130.4 ± 9.5 |
| SBP after | 117.2 ± 9.2 | 121.2 ± 8.2 |
Fasting blood samples were taken at the beginning and end of each treatment period.
| mmol/L | Atenolol | Nebivolol |
|---|---|---|
| Before | 5.0 ± 1.0 | 5.1 ± 0.9 |
| After | 4.9 ± 1.0 | 5.1 ± 0.9 |
Fasting blood samples were taken at the beginning and end of each treatment period.
| percentage of glycosylated hemoglobin | Atenolol | Nebivolol |
|---|---|---|
| Before | 5.7 ± 0.8 | 5.7 ± 0.8 |
| After | 5.7 ± 0.4 | 5.7 ± 0.3 |
Body weights and heights were taken at the beginning and end of each treatment period.
| kg/m^2 | Atenolol | Nebivolol |
|---|---|---|
| Before | 28.1 ± 4.6 | 28.2 ± 4.7 |
| After | 28.0 ± 4.4 | 28.3 ± 4.7 |
Collected over 32 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atenolol 25mg Daily | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Nebivolol 2.5mg Daily | 0/54 (0%) | 0/54 (0%) | 0/54 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 61.1 ± 11 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 29 |
| Male | 25 |
| BMI(kg/m^2) | All Participants |
|---|---|
| Mean | 27.2 ± 6.7 |
| Current Smoker(Participants) | All Participants |
|---|---|
| Count of participants | 14 |
| Ex-smoker(Participants) | All Participants |
|---|---|
| Count of participants | 14 |
| Systolic Blood Pressure (SBP)(mmHg) | All Participants |
|---|---|
| Mean | 129.4 ± 13.2 |
| Diastolic Blood Pressure (DBP)(mmHg) | All Participants |
|---|---|
| Mean | 81.3 ± 9.0 |
| Heart Rate(bpm) | All Participants |
|---|---|
| Mean | 71.1 ± 8.9 |
2 further baseline measures are reported on the registry.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2006 to primary completion in Jan 2009, 30 months.
Results were first posted in Dec 2019, 10 years 11 months after primary completion.
Of 1,339 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 42. This study's 30 months is above that.
Counting every sponsor, half of 1,433 studies reached it within 23 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Atenolol