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

• ClinicalTrials.gov Identifier: NCT01099397
• Recruitment Status: Completed
• First Posted: April 7, 2010
• Results First Posted: September 3, 2012
• Last Update Posted: April 3, 2018
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

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.

Condition or disease	Intervention/treatment
Prediabetic State	Other: Oral glucose tolerance test

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).

Study Design

• Study Type: Observational
• Actual Enrollment: 26 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
• Study Start Date: May 2009
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2010

Groups and Cohorts

Group/Cohort	Intervention/treatment
PEAR Participants; All participants eligible for PEAR study. Each participant will be have fasting and oral glucose tolerance test data collected.	Other: 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.; Other Names: OGTT; Glucose tolerance diagnostic test; Glucose tolerance test; Glucola; Sugar beverage

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s) ]
   A single cohort of patients was followed through participation in the parent study, PEAR, and had both fasting and 2-hour OGTT labs evaluated at three time points. At each of these time points the two methods for evaluating prediabetes were compared. Consistent with the definition for prediabetes recommended by the American Diabetes Association, a fasting glucose above 99mg/dL or 2-hour oral glucose tolerance test glucose above 139mg/dL was considered prediabetic for this study.

Biospecimen Retention:   Samples With DNA

Serum and plasma

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, PEAR participants

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.

Contacts and Locations

Locations

United States, Florida

University of Florida Department of Community Health and Family Medicine

Gainesville, Florida, United States, 32610

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Julie A Johnson, PharmD; University of Florida

More Information

Additional Information:

Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) ClinicalTrials website 

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01099397
• Other Study ID Numbers: UFIRB2372009 - N; U01GM074492 ( U.S. NIH Grant/Contract )
• First Posted: April 7, 2010
• Results First Posted: September 3, 2012
• Last Update Posted: April 3, 2018
• Last Verified: March 2018

Keywords provided by University of Florida:

Glucose; Glucose Tolerance Test; Insulin Resistance; Metabolic adverse effects; Hypertension; Beta-blocker; Atenolol; Diuretic; Hydrochlorothiazide; Blood pressure

Additional relevant MeSH terms:

Glucose Intolerance; Prediabetic State; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases