Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers

Study Overview
=================
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.

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.

Official Title
-----------------
Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Glucose


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>The subjects will be undergoing a oral glucose tolerance test. | Other: Glucose<br>* Oral Glucose Tolerance Test<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-cholesterol, fatty acids, total cholesterol |  | Baseline lab values from PEAR and before the start of pharmacokinetic study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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