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Myocardial Function & FFA Metabolism in HIV Metabolic Syndrome (WU197)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kevin Yarasheski, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00656851
First received: April 10, 2008
Last updated: August 19, 2013
Last verified: August 2013
Results First Received: April 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: HIV Infections
Cardiovascular Disease
Insulin Resistance
HIV Lipodystrophy
The Metabolic Syndrome
Interventions: Drug: Pioglitazone
Behavioral: Exercise Training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty four participants were enrolled from the AIDS Clinical Trials Unit and Infectious Diseases Clinics at Washington University School of Medicine in St. Louis, Missouri, USA. This was a prospective, two-group, random assignment study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria: medications or dietary supplements that affect metabolism (β-blocker, β-agonist, Ca2+ channel blocker, corticosteroid), neuromuscular disorder that affects metabolism or ability to exercise, consumed >3 alcohol drinks/wk, active Hep C or B, recreational-anabolic -appetite stimulant drugs, regular physical exercise.

Reporting Groups
  Description
Pioglitazone Pioglitazone (Actos, 30mg/day for 16 weeks)
Exercise Training Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks

Participant Flow:   Overall Study
    Pioglitazone     Exercise Training  
STARTED     12     12  
COMPLETED     12     8  
NOT COMPLETED     0     4  
Withdrawal by Subject                 0                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pioglitazone Pioglitazone (Actos, 30mg/day for 16 weeks)
Exercise Training Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Total Total of all reporting groups

Baseline Measures
    Pioglitazone     Exercise Training     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     12     24  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  42  ± 7     41  ± 6     42  ± 6  
Gender  
[units: participants]
     
Female     3     0     3  
Male     9     12     21  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   Myocardial Glucose Utilization Rate   [ Time Frame: Weeks 0 and 16 ]

2.  Primary:   Myocardial Glucose Utilization Rate Per Unit Insulin   [ Time Frame: Weeks 0 and 16 ]

3.  Primary:   Myocardial Fatty Acid Utilization Rate   [ Time Frame: Weeks 0 and 16 ]

4.  Primary:   Myocardial Fatty Acid Oxidation Rate   [ Time Frame: Weeks 0 and 16 ]

5.  Primary:   Myocardial Fatty Acid Esterification   [ Time Frame: Weeks 0 and 16 ]

6.  Secondary:   Myocardial Contractile Function During Diastole   [ Time Frame: Weeks 0 and 16 ]

7.  Secondary:   Myocardial Contractile Function During Systole   [ Time Frame: Weeks 0 and 16 ]

8.  Secondary:   Fasting Lipids and Lipoproteins   [ Time Frame: Week 0 and 16 ]

9.  Secondary:   Fasting Glucose Insulin and HOMA   [ Time Frame: Week 0 and 16 ]


  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Pioglitazone Pioglitazone (Actos, 30mg/day for 16 weeks)
Exercise Training Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks

Serious Adverse Events
    Pioglitazone     Exercise Training  
Total, serious adverse events      
# participants affected / at risk     0/12 (0.00%)     0/8 (0.00%)  




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
We did not perform the myocardial metabolic measurements under insulin-stimulated conditions (i.e. hyperinsulinemic clamps). Small number of participants and high measurement variability, efficacy was not found. Study ended to minimize risk/benefit.


  More Information
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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:  
Name/Title: Kevin Yarasheski, PhD
Organization: Washington Univ Med Sch
phone: 3143628173
e-mail: key@wustl.edu


Publications of Results:

Responsible Party: Kevin Yarasheski, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00656851     History of Changes
Other Study ID Numbers: DK59531 (completed), HRPO 05-0976
Study First Received: April 10, 2008
Results First Received: April 30, 2013
Last Updated: August 19, 2013
Health Authority: United States: Federal Government