Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers - Full Text View

Sponsor:	University of Florida
Information provided by:	University of Florida
ClinicalTrials.gov Identifier:	NCT00607347

Purpose

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	Intervention
Hypertension	Other: Glucose

Study Type:	Interventional
Study Design:	Prevention, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Dextrose Atenolol

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	24
Study Start Date:	February 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental The subjects will be undergoing a oral glucose tolerance test.	Other: Glucose Oral Glucose Tolerance Test

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607347

Locations

United States, Florida
University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator:

Julie A. Johnson, PharmD

University of Florida

More Information

No publications provided

Responsible Party:	University of Florida ( Julie A. Johnson )
Study ID Numbers:	UF IRB 591-2007, UO1 GM074492, GCRC grant RR00082
Study First Received:	January 15, 2008
Last Updated:	December 14, 2009
ClinicalTrials.gov Identifier:	NCT00607347 History of Changes
Health Authority:	United States: Institutional Review Board

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:

Sympatholytics
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Atenolol
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010