Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers|
- 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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
- HDL-cholesterol, fatty acids, total cholesterol [ Time Frame: Baseline lab values from PEAR and before the start of pharmacokinetic study ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
The subjects will be undergoing a oral glucose tolerance test.
Oral Glucose Tolerance Test
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607347
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Julie A. Johnson, PharmD||University of Florida|