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Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00607347
First received: January 15, 2008
Last updated: September 16, 2011
Last verified: December 2009
  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: 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

Resource links provided by NLM:


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
Experimental: A
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
ClinicalTrials.gov Identifier: NCT00607347     History of Changes
Other Study ID Numbers: UF IRB 591-2007, UO1 GM074492, GCRC grant RR00082
Study First Received: January 15, 2008
Last Updated: September 16, 2011
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:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Atenolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014