Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers

NCT ID: NCT00607347

Last Updated: 2011-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-06-30

Brief Summary

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The researchers hypothesize that the impact of increasing systemic exposure to atenolol leads to increased risk for adverse metabolic effects from atenolol therapy in hypertension. This will be accomplished through a 24-hour pharmacokinetic (PK) study and oral glucose tolerance test in hypertensive patients taking chronic atenolol 100 mg daily.

Detailed Description

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The current study is a sub-study of Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR - NCT00246519). The primary objective of this pharmacokinetic (PK) study is to investigate the correlation of atenolol Cp with hypertriglyceridemia and insulin sensitivity in mild to moderate hypertensive patients after 6-8 weeks of atenolol treatment.

Participants will undergo the PK study when they have been on atenolol 100 mg once daily for at least 4 weeks and on atenolol therapy (50 mg or 100 mg) for ≥ 7 weeks. They will undergo a two hour Oral Glucose Tolerance Test (OGTT), 1 hour after atenolol dosing. Blood will be drawn at 12 time points for 24 hours. Atenolol Cp will be measured in all 12 blood samples and will be correlated with the glucose/insulin measured during the OGTT.

Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

The subjects will be undergoing a oral glucose tolerance test.

Group Type EXPERIMENTAL

Glucose

Intervention Type OTHER

Oral Glucose Tolerance Test

Interventions

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Glucose

Oral Glucose Tolerance Test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subjects from PEAR who are on atenolol 100 mg once daily will be invited to participate

Exclusion Criteria

* Patients with BMI \>35 kg/m2 will be excluded
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie A. Johnson, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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U01GM074492

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCRC grant RR00082

Identifier Type: -

Identifier Source: secondary_id

UF IRB 591-2007

Identifier Type: -

Identifier Source: org_study_id

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