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

NCT01099397 | Completed Results

• 2 other identifiers: UFIRB2372009 - NU01GM074492
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State

Keywords

Glucose; Glucose Tolerance Test; Insulin Resistance; Metabolic adverse effects; Hypertension; Beta-blocker; Atenolol; Diuretic; Hydrochlorothiazide; Blood pressure

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

PEAR Participants

All participants eligible for PEAR study. Each participant will be have fasting and oral glucose tolerance test data collected.

Other: Oral glucose tolerance test

Interventions

Oral glucose tolerance test OTHER

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.

Also known as: OGTT, Glucose tolerance diagnostic test, Glucose tolerance test, Glucola, Sugar beverage

PEAR Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic, PEAR participants

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Department of Community Health and Family Medicine

Gainesville, Florida, 32610, United States

Location

Related Links

• Pharmacogenomic Evaluation of Antihypertensive Responses (PEAR) ClinicalTrials website

Biospecimen

Retention: SAMPLES WITH DNA

Serum and plasma

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Hypertension

Interventions

Glucose Tolerance Test; Glucola; Sugar-Sweetened Beverages

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

This was a pilot study to evaluate two glucose phenotypes in a small sample from a larger trial. As such, our sample size was small. Further, if participants were withdrawn from the parent trial, they were also withdrawn from the sub-study.

Results Point of Contact

• Title: Mariellen Moore
• Organization: University of Florida

marielm@ufl.edu

352-273-6381

Study Officials

• Julie A Johnson, PharmD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 7, 2010
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 3, 2018
• Results First Posted: September 3, 2012

Record last verified: 2018-03

Locations

US (1)