NCT00607347

Brief Summary

The researchers hypothesize that the impact of increasing systemic exposure to atenolol leads to increased risk for adverse metabolic effects from atenolol therapy in hypertension. This will be accomplished through a 24-hour pharmacokinetic (PK) study and oral glucose tolerance test in hypertensive patients taking chronic atenolol 100 mg daily.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2008

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 20, 2011

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

January 15, 2008

Last Update Submit

September 16, 2011

Conditions

Hypertension

Keywords

Keywords by National Institute of General Medical SciencesHypertensionAdverse metabolic effectsBeta blockersDyslipidemiaAtenololNew onset diabetesPharmacokinetic studyOral glucose tolerance test

Outcome Measures

Primary Outcomes (1)

  • Correlation of area under curve (AUC) up to 24 hour time point of atenolol plasma drug concentrations and glucose/insulin values obtained from OGTT and triglycerides

    Glucose/insulin will be measured during 2 hour Oral Glucose Tolerance Test and from baseline measurements from PEAR, triglycerides will be measured from baseline lab measurements from PEAR and during the pharmacokinetic study

Secondary Outcomes (1)

  • HDL-cholesterol, fatty acids, total cholesterol

    Baseline lab values from PEAR and before the start of pharmacokinetic study

Study Arms (1)

A

EXPERIMENTAL

The subjects will be undergoing a oral glucose tolerance test.

Other: Glucose

Interventions

GlucoseOTHER

Oral Glucose Tolerance Test

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects from PEAR who are on atenolol 100 mg once daily will be invited to participate

You may not qualify if:

  • Patients with BMI \>35 kg/m2 will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

Glucose

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Julie A. Johnson, PharmD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2008

First Posted

February 5, 2008

Study Start

February 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 20, 2011

Record last verified: 2009-12

Locations

US(1)