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Trial record 91 of 116 for:    Atenolol

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Drug Induced Hyperglycemia
Secondary Hyperlipidemia
Intervention Drug: Oral Glucose Tolerance Test
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Period Title: Overall Study
Started 44
Completed 40
Not Completed 4
Reason Not Completed
Protocol Violation             4
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
Patients previously enrolled in the PEAR 1 or 2 study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
49  (10)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
41
  93.2%
>=65 years
3
   6.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
24
  54.5%
Male
20
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
Fasting Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 44 participants
91  (12)
1.Primary Outcome
Title Fasting Glucose (mg/dL)
Hide Description [Not Specified]
Time Frame Fasting glucose was obtained at time 0 min.
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 44 patients were included in the study, however 4 patients were treated with anti-diabetic medications and so were excluded from the analysis. Therefore there are a total of 40 patients that were included in the analysis.
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description:

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mg/dL
94  (13)
2.Secondary Outcome
Title Oral Glucose Tolerance Test (mg/dl h)
Hide Description 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.
Time Frame one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that underwent an OGTT
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description:

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mg/dL*h
273  (74)
3.Secondary Outcome
Title Triglycerides (mg/dL)
Hide Description [Not Specified]
Time Frame Triglycerides was obtained at time 0 min.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description:

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mg/dl
157  (89)
4.Secondary Outcome
Title Low Density Lipoprotein (mg/dL)
Hide Description [Not Specified]
Time Frame Low Density Lipoprotein was obtained at time 0 min.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description:

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mg/dL
117  (36)
5.Secondary Outcome
Title High Density Lipoprotein (mg/dL)
Hide Description [Not Specified]
Time Frame High Density Lipoprotein was obtained at time 0 min.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description:

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mg/dL
52  (17)
Time Frame 3 hour study visit
Adverse Event Reporting Description Subjects were monitored over the single 3 hour study visit.
 
Arm/Group Title Follow-Up Arm
Hide Arm/Group Description

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.

Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).

All-Cause Mortality
Follow-Up Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Follow-Up Arm
Affected / at Risk (%)
Total   0/44 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Follow-Up Arm
Affected / at Risk (%)
Total   0/44 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Rhonda Cooper-DeHoff
Organization: University of Florida
Phone: 352-273-6184
EMail: dehoff@cop.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01409434     History of Changes
Other Study ID Numbers: PEAR Follow-Up
First Submitted: August 1, 2011
First Posted: August 4, 2011
Results First Submitted: July 16, 2014
Results First Posted: October 16, 2014
Last Update Posted: October 16, 2014