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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00656851
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : August 20, 2013
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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
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 
Withdrawal by Subject                0                4 

  Baseline Characteristics

  Outcome Measures

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

  Other Adverse Events

  Limitations and Caveats

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

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
First Submitted: April 10, 2008
First Posted: April 11, 2008
Results First Submitted: April 30, 2013
Results First Posted: August 20, 2013
Last Update Posted: August 28, 2013