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| Name | Class |
|---|---|
| Foundation for Circulatory Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atenolol 25mg daily | Experimental | atenolol 25mg daily |
|
| nebivolol 2.5mg daily | Active Comparator | nebivolol 2.5mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | Drug | Nebivolol 2.5mg daily |
| |
| Atenolol |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load.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. | Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before and after 8 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil R Poulter | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | Paddington | London | W2 1PG | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wash-out (4 Weeks) |
| |||||||||||||
| First Intervention (8 Weeks) |
| |||||||||||||
| Wash-out (4 Weeks) |
| |||||||||||||
| Second Intervention (8 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Crossover study design all participants will receive both treatments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Inter-Quartile Range | factor | Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment |
|
32 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atenolol 25mg Daily | atenolol 25mg daily Atenolol: Atenolol 25mg daily | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Neil Poulter | Imperial College London | +44 2075943445 | n.poulter@imperial.ac.uk |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| D001262 | Atenolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
Atenolol 25mg daily |
|
| Total Cholesterol | Fasting blood samples were taken at the beginning and end of each treatment period. | Before and after 8 weeks of treatment |
| HbA1c | Fasting blood samples were taken at the beginning and end of each treatment period. | Before and after 8 weeks of treatment |
| BMI | Body weights and heights were taken at the beginning and end of each treatment period. | Before and after 8 weeks of treatment |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | kg/m2 | Mean | Standard Deviation | kg/m^2 |
|
| Current Smoker | Count of Participants | Participants |
|
| Ex-smoker | Count of Participants | Participants |
|
| Systolic Blood Pressure (SBP) | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure (DBP) | Mean | Standard Deviation | mmHg |
|
| Heart Rate | Mean | Standard Deviation | bpm |
|
| HBa1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
|
| Total Cholesterol | Mean | Standard Deviation | mmol/L |
|
| Atenolol |
Participants received Atenolol 25mg daily for 8 weeks |
| OG001 | Nebivolol | Participants received Nebivolol 2.5mg daily for 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg | Before and after 8 weeks of treatment |
|
|
|
|
| Secondary | Total Cholesterol | Fasting blood samples were taken at the beginning and end of each treatment period. | Posted | Mean | Standard Deviation | mmol/L | Before and after 8 weeks of treatment |
|
|
|
|
| Secondary | HbA1c | Fasting blood samples were taken at the beginning and end of each treatment period. | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin | Before and after 8 weeks of treatment |
|
|
|
|
| Secondary | BMI | Body weights and heights were taken at the beginning and end of each treatment period. | Posted | Mean | Standard Deviation | kg/m^2 | Before and after 8 weeks of treatment |
|
|
|
|
| 54 |
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Nebivolol 2.5mg Daily | nebivolol 2.5mg daily Nebivolol: Nebivolol 25mg daily | 0 | 54 | 0 | 54 | 0 | 54 |
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| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D020005 | Propanols |