Clinical trial NCT01099397: Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
Official title: Antihypertensive Medication Exposure as Risk for Impaired Glucose Tolerance: A PEAR Sub-Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prediabetic State
Keywords: Glucose
Glucose Tolerance Test
Insulin Resistance
Metabolic adverse effects
Hypertension
Beta-blocker
Atenolol
Diuretic
Hydrochlorothiazide
Blood pressure
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-04-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic, PEAR participants

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).

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.

Primary outcomes:
measure: 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
timeFrame: Baseline, 9 weeks, and 18 weeks after initiation of PEAR intervention(s)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Department of Community Health and Family Medicine
state: Florida
Study officials:
affiliation: University of Florida
name: Julie A Johnson, PharmD
role: PRINCIPAL_INVESTIGATOR
References: