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

NCT01409434 | Completed Phase 4 Results

• 1 other identifier: PEAR Follow-Up
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Induced Hyperglycemia; Secondary Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• Fasting Glucose (mg/dL)

  Fasting glucose was obtained at time 0 min.

Secondary Outcomes (4)

• Oral Glucose Tolerance Test (mg/dl h)

  one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)

• Triglycerides (mg/dL)

  Triglycerides was obtained at time 0 min.

• Low Density Lipoprotein (mg/dL)

  Low Density Lipoprotein was obtained at time 0 min.

• High Density Lipoprotein (mg/dL)

  High Density Lipoprotein was obtained at time 0 min.

Study Arms (1)

Follow-Up Arm

OTHER

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.

Drug: Oral Glucose Tolerance Test

Interventions

Oral Glucose Tolerance Test DRUG

Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Also known as: Glucose Drink 100

Follow-Up Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• previously enrolled in PEAR study
• completed last PEAR study visit greater than 6 months prior
• receive thiazide diuretic continuously since PEAR enrollment

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida College of Pharmacy

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Results Point of Contact

• Title: Dr. Rhonda Cooper-DeHoff
• Organization: University of Florida

dehoff@cop.ufl.edu

352-273-6184

Study Officials

• Rhonda M Cooper-DeHoff, PharmD, MS

  University of Florida

  PRINCIPAL INVESTIGATOR

• Jason H Karnes, PharmD

  University of Florida

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 4, 2011
• Study Start: June 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 16, 2014
• Results First Posted: October 16, 2014

Record last verified: 2014-10

Locations

US (1)