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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Nebivolol Drug: Atenolol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity |
Actual Study Start Date : | July 2006 |
Actual Primary Completion Date : | January 2009 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: atenolol 25mg daily
atenolol 25mg daily
|
Drug: Atenolol
Atenolol 25mg daily |
Active Comparator: nebivolol 2.5mg daily
nebivolol 2.5mg daily
|
Drug: Nebivolol
Nebivolol 2.5mg daily |
- 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 Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load.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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125853
United Kingdom | |
Imperial College London | |
Paddington, London, United Kingdom, W2 1PG |
Principal Investigator: | Neil R Poulter | Imperial College London |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT00125853 |
Other Study ID Numbers: |
NPSW02 |
First Posted: | August 2, 2005 Key Record Dates |
Results First Posted: | December 12, 2019 |
Last Update Posted: | December 12, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
blood pressure insulin sensitivity beta blockers randomised double blind crossover trial |
Insulin Resistance Hypersensitivity Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Atenolol Nebivolol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Vasodilator Agents Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |