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

Prediabetic State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099397
• Other study ID #: UFIRB2372009 - N
• Secondary ID: U01GM074492
• Status: Completed
• First received: April 1, 2010
• Last updated: March 30, 2018
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida Department of Community Health and Family Medicine	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)

External Links

•   Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) ClinicalTrials website