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

NCT ID: NCT01099397

Last Updated: 2018-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-12-31

Brief 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.

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).

Conditions

Prediabetic State

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PEAR Participants

All participants eligible for PEAR study. Each participant will be have fasting and oral glucose tolerance test data collected.

Oral glucose tolerance test

Intervention Type: OTHER

For assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.

Interventions

Oral glucose tolerance test

For assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.

Intervention Type: OTHER

Other Intervention Names

OGTT; Glucose tolerance diagnostic test; Glucose tolerance test; Glucola; Sugar beverage

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie A Johnson, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Department of Community Health and Family Medicine

Gainesville, Florida, United States

Countries

United States

Related Links

http://clinicaltrials.gov/ct2/show/NCT00246519?term=NCT00246519&rank=1

Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) ClinicalTrials website

Other Identifiers

U01GM074492

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UFIRB2372009 - N

Identifier Type: -

Identifier Source: org_study_id