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

Arm | Intervention/treatment |
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Experimental: A
The subjects will be undergoing a oral glucose tolerance test.
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Other: Glucose
Oral Glucose Tolerance Test |
- 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 ]
- HDL-cholesterol, fatty acids, total cholesterol [ Time Frame: Baseline lab values from PEAR and before the start of pharmacokinetic study ]

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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 |
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

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
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Julie A. Johnson, PharmD | University of Florida |
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 by National Institute of General Medical Sciences Hypertension Adverse metabolic effects Beta blockers Dyslipidemia |
Atenolol New onset diabetes Pharmacokinetic study Oral glucose tolerance test |
Hypertension Vascular Diseases Cardiovascular Diseases |