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Trial record 22 of 116 for:    Atenolol

Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00925119
Recruitment Status : Terminated
First Posted : June 19, 2009
Results First Posted : December 22, 2017
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Amber Beitelshees, University of Maryland, Baltimore

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Intervention Drug: Atenolol
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Period Title: Overall Study
Started 31
Completed 19
Not Completed 12
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
57  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
11
  57.9%
Male
8
  42.1%
1.Primary Outcome
Title Change in Diastolic Function (Annular Tissue Velocity [Em])
Hide Description [Not Specified]
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not able to be collected from the echocardiography.
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Change in Free Fatty Acid Kinetics
Hide Description Estimate of peripheral lipolysis using modeling of free fatty acid levels collected during an IV glucose tolerance test. The change in threshold for insulin action (post-atenolol minus pre-atenolol) is the primary variable from this modeling that we analyzed.
Time Frame Baseline and Week 8
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Hide Analysis Population Description
Modeling data not available in all subjects
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: mU/mL
2.02  (16.5)
3.Secondary Outcome
Title Change in Triglycerides
Hide Description (Post atenolol triglycerides - Pre atenolol triglycerides)
Time Frame Baseline and Week 8
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Hide Analysis Population Description
Data available in 17 subjects
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mg/dL
17  (65)
4.Secondary Outcome
Title Change in Insulin Sensitivity
Hide Description

As measured by the Homeostatic model assessment of insulin resistance (HOMA2-IR) (post atenolol - pre atenolol).

he Homeostatic model assessment (HOMA) is a method for assessing insulin sensitivity from fasting glucose and insulin. A higher HOMA value indicates higher insulin resistance. The widely-used formulae available for HOMA1 provide only linear approximations of HOMA_%B and HOMA_IR, the inverse of HOMA_%S. These are: HOMA1_IR = [FPI (uU/ml) x FPG (mmol/l) ]/22.5 HOMA1_%B = (20 x FPI)/(FPG - 3.5) The results obtained for HOMA2 may differ considerably from HOMA1 computer-calculated values, especially for more extreme glucose and insulin values. For this reason, no attempt has been made to provide linear approximations of HOMA2 calculated values of HOMA_%B, HOMA_IR and HOMA_%S. The software needed to calculate HOMA2 values is available on this website: https://www.dtu.ox.ac.uk/homacalculator/download.php, subject to the conditions specified on the downloads page.

Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Post and Pre atenolol data available in 17 subjects
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: arbitrary units
-0.05  (0.84)
5.Secondary Outcome
Title Change in Glucose Effectiveness
Hide Description Glucose effectiveness as measured by insulin-modified IV glucose tolerance test using the MINMOD model.
Time Frame Baseline and Week 8
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Hide Analysis Population Description
Data could not be determined because assumptions for MINMOD model were not met.
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in HDL
Hide Description [Not Specified]
Time Frame Baseline and Week 8
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
-3.5  (5.8)
7.Secondary Outcome
Title Change in Insulin
Hide Description fasting insulin (post - pre atenolol)
Time Frame Baseline and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: mU/mL
-0.55  (6.03)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atenolol
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Participants will receive atenolol for 8 weeks.

Atenolol: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated

All-Cause Mortality
Atenolol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Atenolol
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atenolol
Affected / at Risk (%)
Total   4/19 (21.05%) 
Cardiac disorders   
Bradycardia  4/19 (21.05%) 
General disorders   
Fatigue  2/19 (10.53%) 
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
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Name/Title: Dr. Amber Beitelshees
Organization: University of Maryland
Phone: 410-706-0118
EMail: abeitels@medicine.umaryland.edu
Layout table for additonal information
Responsible Party: Amber Beitelshees, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT00925119     History of Changes
Other Study ID Numbers: HP-00040291
K23HL091120 ( U.S. NIH Grant/Contract )
First Submitted: June 17, 2009
First Posted: June 19, 2009
Results First Submitted: April 21, 2017
Results First Posted: December 22, 2017
Last Update Posted: September 26, 2019