Official Title: “Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers”

We hypothesise 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 Type: Interventional

Study Design: Prevention, Open Label, Single Group Assignment, Pharmacokinetics Study

Study Primary Completion Date: January 2010

The current study is a sub-study of Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR),(NCT00246519). The primary objective of this pharmacokinetic 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 100mg once daily for at least 4 weeks and on atenolol therapy (50mg or 100mg) 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 24hours. Atenolol Cp will be measured in all 12 blood samples and will be correlated with the glucose/insulin measured during the OGTT.

Intervention(s) in this Clinical Trial

• Other: Glucose
  • Oral Glucose Tolerance Test

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • The subjects will be undergoing a oral glucose tolerance test.

Primary Measures

• Corelation of area under curve (AUC)upto 24hour 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
    Safety Issue?: No

Secondary Measures

• HDL-cholesterol, fatty acids, total cholesterol
  • Time Frame: Baseline lab values from PEAR and before the start of pharmacokinetic study
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Florida

Overall Clinical Trial Officials and Contacts

Julie A. Johnson, PharmD Principal Investigator University of Florida  

Overall Contact: Julie A. Johnson, Pharm D. 352-273-6007 johnson@cop.ufl.edu

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607347

Study ID Number: UF IRB 591-2007

ClinicalTrials.gov Identifier: NCT00607347

Health Authority: United States: Institutional Review Board