- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00125853
The Effect of Nebivolol on Insulin Sensitivity
A Trial to Compare the Effects of Nebivolol Versus Atenolol on Various Cardiovascular Measurements Including Insulin Sensitivity
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
London
-
Paddington, London, United Kingdom, W2 1PG
- Imperial College London
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: atenolol 25mg daily
|
Atenolol 25mg daily
|
Active Comparator: nebivolol 2.5mg daily
|
Nebivolol 2.5mg daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 Venous blood was withdrawn for insulin and glucose analysis, 15 minutes and immediately prior to, and 30, 60, 90 and 120 minutes following an oral glucose load.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. |
Baseline, 15, 30, 60, 90, 120m following oral glucose load, at baseline and at the end of each phase(8 weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before and after 8 weeks of treatment
|
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.
|
Before and after 8 weeks of treatment
|
HbA1c
Time Frame: Before and after 8 weeks of treatment
|
Fasting blood samples were taken at the beginning and end of each treatment period.
|
Before and after 8 weeks of treatment
|
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.
|
Before and after 8 weeks of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Hyperinsulinism
- Hypersensitivity
- Insulin Resistance
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic beta-1 Receptor Agonists
- Nebivolol
- Atenolol
Other Study ID Numbers
- NPSW02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Recruiting
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
China Academy of Chinese Medical SciencesGuang'anmen Hospital of China Academy of Chinese Medical SciencesCompletedHypertension, Resistant to Conventional Therapy | Primary HypertensionChina
Clinical Trials on Atenolol
-
Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Center for Research...Completed
-
Seoul National University HospitalCompleted
-
Shanghai Jiao Tong University School of MedicineRecruiting
-
SandozCompletedHypertension | Angina
-
Brigham and Women's HospitalUniversity of UtahWithdrawnHypertensionUnited States
-
Saini FoundationMedtronic - MITGUnknown
-
Sundeep Khosla, M.D.Columbia University; University of California, San Francisco; MaineHealthRecruiting
-
National Taiwan University HospitalUnknown
-
Ranbaxy Laboratories LimitedCompleted