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Long Term Antihypertensive Exposure and Adverse Metabolic Effects: PEAR Follow-Up Study

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ClinicalTrials.gov Identifier: NCT01409434
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : October 16, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE August 1, 2011
First Posted Date  ICMJE August 4, 2011
Results First Submitted Date  ICMJE July 16, 2014
Results First Posted Date  ICMJE October 16, 2014
Last Update Posted Date October 16, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
Fasting Glucose (mg/dL) [ Time Frame: Fasting glucose was obtained at time 0 min. ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
Fasting Glucose (mg/dL) [ Time Frame: For the duration of the single study visit (expected average of 3 hours) ]
Change History Complete list of historical versions of study NCT01409434 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
  • 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) ]
    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.
  • Triglycerides (mg/dL) [ Time Frame: Triglycerides was obtained at time 0 min. ]
  • Low Density Lipoprotein (mg/dL) [ Time Frame: 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • Oral Glucose Tolerance Test [ Time Frame: For the duration of the single study visit (expected average of 3 hours) ]
  • Triglycerides (mg/dL) [ Time Frame: For the duration of the single study visit (expected average of 3 hours) ]
  • Low Density Lipoprotein (mg/dL) [ Time Frame: For the duration of the single study visit (expected average of 3 hours) ]
  • High Density Lipoprotein (mg/dL) [ Time Frame: For the duration of the single study visit (expected average of 3 hours) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Antihypertensive Exposure and Adverse Metabolic Effects: PEAR Follow-Up Study
Official Title  ICMJE Long Term Antihypertensive Exposure and Adverse Metabolic Effects: PEAR Follow-Up Study
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Drug Induced Hyperglycemia
  • Secondary Hyperlipidemia
Intervention  ICMJE Drug: Oral Glucose Tolerance Test
Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
Other Name: Glucose Drink 100
Study Arms  ICMJE 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.
Intervention: Drug: Oral Glucose Tolerance Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2013)
44
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2011)
125
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01409434
Other Study ID Numbers  ICMJE PEAR Follow-Up
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rhonda M Cooper-DeHoff, PharmD, MS University of Florida
Study Director: Jason H Karnes, PharmD University of Florida
PRS Account University of Florida
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP