- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409434
Long Term Antihypertensive Exposure and Adverse Metabolic Effects: PEAR Follow-Up Study
October 10, 2014 updated by: University of Florida
This is a research study of the long term effects on blood sugar and cholesterol of blood pressure lowering medications.
People are invited to participate in this research study if they participated in the Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR 1, NCT00246519 or PEAR 2, NCT01203852) study and are still taking a thiazide diuretic.
In PEAR, the effects on blood pressure, blood sugar, and cholesterol of the high blood pressure drugs hydrochlorothiazide and atenolol over an 18 week period were evaluated.
This PEAR follow-up study will determine the effects of thiazide diuretics on blood sugar and cholesterol, but in the period since the PEAR trial.
The study hypothesis is that long term exposure to thiazide diuretics results in larger increases in blood sugar and cholesterol levels than short term exposure.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
One in three deaths in the United States is due to cardiovascular (CV) disease.
One in three US adults has hypertension, a major underlying cause of CV disease.
Type 2 diabetes (T2D) and dyslipidemia are major contributors of CV morbidity and mortality among hypertensive patients.
Thiazide diuretics and beta blockers are first line agents in the treatment of hypertension, but these commonly prescribed antihypertensive classes can contribute to dysfunction of glucose and lipid metabolism.
In randomized controlled trials, reductions in CV outcomes due to blood pressure reduction with thiazide diuretic and beta blocker treatment are accompanied by increases in T2D incidence and exacerbation of dyslipidemia.
CV morbidity and mortality resulting from persistent antihypertensive-related T2D or dyslipidemia may eventually outweigh benefits from blood pressure reduction, encouraging use of alternate antihypertensive classes especially in high risk patients.
An accumulating body of published literature supports that adverse metabolic effects are induced by thiazide diuretics and beta blockers.
However, the vast majority of evidence for adverse metabolic effects of antihypertensive drugs utilizes secondary analyses of data from randomized blood pressure reduction trials.
To date, no published study has compared short and long term adverse metabolic effects of antihypertensive therapy in the same patient population.
The Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) study is a randomized, parallel assignment trial to determine genetic influences on blood pressure response to the thiazide diuretic hydrochlorothiazide and the beta blocker atenolol.
The PEAR study duration (18 weeks) is not sufficient to assess long term effects (over six months) of these antihypertensive medications.
The primary aim of this study is to determine the effects of long term thiazide and beta blocker therapy on glucose and lipid metabolism in the PEAR population, in which short term effects have been assessed.
Secondary analyses of this follow-up study include investigating adverse metabolic effects of long term thiazide diuretic and beta blocker therapy on insulin sensitivity and the role of potassium and uric acid in the hyperglycemic effects of thiazide diuretics.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida College of Pharmacy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- previously enrolled in PEAR study
- completed last PEAR study visit greater than 6 months prior
- receive thiazide diuretic continuously since PEAR enrollment
Exclusion Criteria:
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Follow-Up Arm
All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study.
The Follow-Up Arm includes a one time study visit in which study interventions are performed.
The Follow-Up Arm involves patients from the parent study who were enrolled in the follow-up study.
The intervention in the Follow-Up Arm is the Oral Glucose Tolerance Test.
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Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fasting Glucose (mg/dL)
Time Frame: Fasting glucose was obtained at time 0 min.
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Fasting glucose was obtained at time 0 min.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral Glucose Tolerance Test (mg/dl h)
Time Frame: one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)
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Area under the curve for the OGTT was calculated for each patient using the 3 time points (0 hour, 1 hour and 2 hour).
Average value for participants is provided.
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one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)
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Triglycerides (mg/dL)
Time Frame: Triglycerides was obtained at time 0 min.
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Triglycerides was obtained at time 0 min.
|
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Low Density Lipoprotein (mg/dL)
Time Frame: Low Density Lipoprotein was obtained at time 0 min.
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Low Density Lipoprotein was obtained at time 0 min.
|
|
High Density Lipoprotein (mg/dL)
Time Frame: High Density Lipoprotein was obtained at time 0 min.
|
High Density Lipoprotein was obtained at time 0 min.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jason H Karnes, PharmD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ACTUAL)
August 1, 2013
Study Registration Dates
First Submitted
August 1, 2011
First Submitted That Met QC Criteria
August 2, 2011
First Posted (ESTIMATE)
August 4, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
October 16, 2014
Last Update Submitted That Met QC Criteria
October 10, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEAR Follow-Up
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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