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Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers

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ClinicalTrials.gov Identifier: NCT00607347
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : September 20, 2011
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Other: Glucose Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers
Study Start Date : February 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
The subjects will be undergoing a oral glucose tolerance test.
 Other: Glucose
Oral Glucose Tolerance Test


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. HDL-cholesterol, fatty acids, total cholesterol [ Time Frame: Baseline lab values from PEAR and before the start of pharmacokinetic study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607347


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Julie A. Johnson, PharmD University of Florida
More Information
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00607347    
Other Study ID Numbers: UF IRB 591-2007
U01GM074492 ( U.S. NIH Grant/Contract )
GCRC grant RR00082
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: December 2009
Keywords provided by University of Florida:
Keywords by National Institute of General Medical Sciences
Hypertension
Adverse metabolic effects
Beta blockers
Dyslipidemia
 Atenolol
New onset diabetes
Pharmacokinetic study
Oral glucose tolerance test
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases