Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/17/2018 |
| Start Date: | May 2009 |
| End Date: | December 2010 |
The purpose of this study is to determine if, in a subset of patients treated with a
beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour
oral glucose tolerance test (OGTT) compared to fasting glucose measurement.
beta-blocker and diuretic, prediabetes is detectable to a greater extent through a 2-hour
oral glucose tolerance test (OGTT) compared to fasting glucose measurement.
Beta-blockers and diuretics have a well-established role in treating hypertension and are
frequently used first-line. However, it is increasingly evident that these medications have
harmful metabolic effects. The Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR
- NCT00246519) study was a greater than 700 participant, randomized, parallel assignment
trial, aimed at determining the genetic factors that influence response to both a
beta-blocker (atenolol) and a diuretic (hydrochlorothiazide [HCTZ]). The PEAR trial design
includes evaluation at baseline, after monotherapy with either medication, and after
combination therapy with both medications. This pilot, PEAR sub-study aims to characterize
the ability of two diagnostics tests (fasting glucose versus glucose 2-hours after an OGTT)
to detect prediabetes development prior to blood pressure medication use, after monotherapy
(with atenolol or HCTZ) and after combination therapy (with atenolol and HCTZ).
frequently used first-line. However, it is increasingly evident that these medications have
harmful metabolic effects. The Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR
- NCT00246519) study was a greater than 700 participant, randomized, parallel assignment
trial, aimed at determining the genetic factors that influence response to both a
beta-blocker (atenolol) and a diuretic (hydrochlorothiazide [HCTZ]). The PEAR trial design
includes evaluation at baseline, after monotherapy with either medication, and after
combination therapy with both medications. This pilot, PEAR sub-study aims to characterize
the ability of two diagnostics tests (fasting glucose versus glucose 2-hours after an OGTT)
to detect prediabetes development prior to blood pressure medication use, after monotherapy
(with atenolol or HCTZ) and after combination therapy (with atenolol and HCTZ).
Inclusion Criteria:
- participation in PEAR:
- an average seated home DBP > 85 mmHg and home SBP < 180 mmHg.
- subjects must also have an average seated (> 5 minutes) clinic DBP between 90
mmHg and 110 mmHg and SBP < 180 mmHg.
Exclusion Criteria:
- secondary forms of HTN,
- patients currently treated with three or more antihypertensive drugs, isolated
systolic HTN,
- other diseases requiring treatment with BP lowering medications,
- heart rate < 55 beats/min,
- known cardiovascular disease (including history of angina pectoris, heart failure,
presence of a cardiac pacemaker, history of myocardial infarction or revascularization
procedure, or cerebrovascular disease, including stroke and TIA),
- diabetes mellitus (Type 1 or 2),
- renal insufficiency (serum creatinine > 1.5 in men or 1.4 in women),
- primary renal disease,
- pregnancy or lactation,
- liver enzymes > 2.5 upper limits of normal,
- current treatment with NSAIDS,
- COX2-inhibitors,
- oral contraceptives or estrogen.
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