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Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study

Information source: University of Florida
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prediabetic State

Intervention: Oral glucose tolerance test (Other)

Phase: N/A

Status: Completed

Sponsored by: University of Florida

Official(s) and/or principal investigator(s):
Julie A Johnson, PharmD, Principal Investigator, Affiliation: University of Florida

Summary

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.

Clinical Details

Official title: Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of Participants Diagnosed With Prediabetes or Normal Glucose, by 2 Measurements (Fasting Glucose Measurement and Glucose Measurement After a 2-hour Oral Glucose Tolerance Test [OGTT]), at Three Timepoints During Antihypertensive Treatment

Detailed description: 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).

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University of Florida Department of Community Health and Family Medicine, Gainesville, Florida 32610, United States
Additional Information

Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) ClinicalTrials website

Starting date: May 2009
Last updated: August 29, 2012

Page last updated: August 23, 2015

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