Exercise and Pioglitazone for HIV-Metabolic Syndromes
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ClinicalTrials.gov Identifier: NCT00639457 |
Recruitment Status
:
Completed
First Posted
: March 20, 2008
Results First Posted
: September 12, 2013
Last Update Posted
: October 23, 2013
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kevin Yarasheski, Washington University School of Medicine
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Study Type: | Interventional |
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Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions: |
HIV Infections Type 2 Diabetes Obesity HIV AIDS Cardiovascular Disease Lipodystrophy |
Interventions: |
Drug: Pioglitazone Behavioral: Exercise training |

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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HIV-infected men and women (18 – 60 yr old) were recruited from the AIDS Clinical Trials Unit, the Infectious Diseases Clinic, and the Volunteers for Health Program at Washington University School of Medicine, St. Louis MO between Jan 2005-Dec 2010. Participants were randomly assigned (1:1) to 4 mo of pioglitazone with or without exercise training. |
Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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Exclusion: AIDS diagnosis, non-compliant with anti-HIV medications, unstable CD4+ T-cell count or plasma HIV viremia, illegal drug abuse. |
Reporting Groups
Description | |
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Pioglitazone | Pioglitazone (Actos; 30mg/day) for 16 weeks. |
Pioglitazone + Exercise Training | Pioglitazone (Actos; 30mg/day) plus progressive aerobic and weight lifting exercise training (1.5hr/day x 3 days/wk)supervised and monitored by a personal exercise trainer. |
Participant Flow: Overall Study
Pioglitazone | Pioglitazone + Exercise Training | |
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STARTED | 22 | 22 |
COMPLETED | 20 | 19 |
NOT COMPLETED | 2 | 3 |
Withdrawal by Subject | 2 | 3 |

1. Primary: | Insulin-stimulated Glucose Disposal Rate [ Time Frame: Baseline and week16 ] |
2. Secondary: | Visceral Fat Volume [ Time Frame: Baseline and week 16 ] |
3. Secondary: | Abdominal Subcutaneous Fat Volume [ Time Frame: Baseline and week 16 ] |
4. Secondary: | Hepatic Lipid Content [ Time Frame: Baseline and week 16 ] |
5. Secondary: | Hepatic Glucose Production Rate [ Time Frame: Baseline and week 16 ] |
6. Secondary: | Serum Lipid and Lipoprotein Levels [ Time Frame: Baseline and week 16 ] |
7. Secondary: | Liver Enzyme Levels [ Time Frame: Baseline and week 16 ] |
8. Secondary: | Hemoglobin [ Time Frame: Baseline and Week 16 ] |
9. Secondary: | Hematocrit [ Time Frame: Baseline and Week 16 ] |
10. Secondary: | Serum Adiponectin Levels [ Time Frame: Baseline and week 16 ] |
11. Secondary: | Myocardial Contractility [ Time Frame: Baseline and week 16 ] |
12. Secondary: | Myocardial Contractility-LV Ejection Time [ Time Frame: Baseline and week 16 ] |
13. Secondary: | Myocardial Contractility-DT [ Time Frame: Baseline and week 16 ] |
14. Secondary: | Myocardial Contractility-SBP [ Time Frame: Baseline and week 16 ] |
15. Secondary: | Myocardial Contractility-DBP [ Time Frame: Baseline and week 16 ] |

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 |
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No intervention and exercise training only control groups were not included. Intracellular mechanisms were not explored. Relatively small number of participants taking a variety of anti-HIV medication regimens. |

Certain Agreements:
Results Point of Contact:
Publications of Results:
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
Organization: Washington Univ Med Sch
phone: 3143628173
e-mail: key@wustl.edu
Publications of Results:
Reeds DN, Cade WT, Mondy K, Bopp C, Lassa-Claxton S, Yarasheski KE. Pioglitazone ± exercise training reduces liver lipid content and improves insulin sensitivity in HIV with impaired glucose tolerance (IGT). Antivir Ther. 12 Suppl 2: L14, 2007.
Responsible Party: | Kevin Yarasheski, Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00639457 History of Changes |
Other Study ID Numbers: |
DK 049393 (completed) WU 157 ( Other Identifier: ACTU Washington University ) |
First Submitted: | March 18, 2008 |
First Posted: | March 20, 2008 |
Results First Submitted: | May 2, 2013 |
Results First Posted: | September 12, 2013 |
Last Update Posted: | October 23, 2013 |