Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Glucose

• Registration Number: NCT00607347
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-01-15
• Study First Submitted QC: 2008-01-24
• Study Start: 2008-02
• Study First Posted: 2008-02-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-12
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Subjects from PEAR who are on atenolol 100 mg once daily will be invited to participate
• Other inclusion criteria from PEAR

Exclusion Criteria

• Patients with BMI >35 kg/m2 will be excluded
• Other exclusion criteria from PEAR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Glucose	The subjects will be undergoing a oral glucose tolerance test.

Primary Outcome Measures

Name	Time	Method
Correlation of area under curve (AUC) up to 24 hour time point of atenolol plasma drug concentrations and glucose/insulin values obtained from OGTT and triglycerides	Glucose/insulin will be measured during 2 hour Oral Glucose Tolerance Test and from baseline measurements from PEAR, triglycerides will be measured from baseline lab measurements from PEAR and during the pharmacokinetic study

Secondary Outcome Measures

Name	Time	Method
HDL-cholesterol, fatty acids, total cholesterol	Baseline lab values from PEAR and before the start of pharmacokinetic study

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States