Hypertension
Conditions
Keywords
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
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.
Interventions
OTHERGlucose
Oral Glucose Tolerance Test
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| HDL-cholesterol, fatty acids, total cholesterol | Baseline lab values from PEAR and before the start of pharmacokinetic study |
Countries
United States
Outcome results
None listed