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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
Sponsor:
Information provided by (Responsible Party):
Kevin Yarasheski, Washington University School of Medicine

Study Type: Interventional
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Exclusion: AIDS diagnosis, non-compliant with anti-HIV medications, unstable CD4+ T-cell count or plasma HIV viremia, illegal drug abuse.

Reporting Groups
  Description
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
STARTED   22   22 
COMPLETED   20   19 
NOT COMPLETED   2   3 
Withdrawal by Subject                2                3 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Insulin-stimulated Glucose Disposal Rate   [ Time Frame: Baseline and week16 ]
  Show Outcome Measure 1

2.  Secondary:   Visceral Fat Volume   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 2

3.  Secondary:   Abdominal Subcutaneous Fat Volume   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 3

4.  Secondary:   Hepatic Lipid Content   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 4

5.  Secondary:   Hepatic Glucose Production Rate   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 5

6.  Secondary:   Serum Lipid and Lipoprotein Levels   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 6

7.  Secondary:   Liver Enzyme Levels   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 7

8.  Secondary:   Hemoglobin   [ Time Frame: Baseline and Week 16 ]
  Show Outcome Measure 8

9.  Secondary:   Hematocrit   [ Time Frame: Baseline and Week 16 ]
  Show Outcome Measure 9

10.  Secondary:   Serum Adiponectin Levels   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 10

11.  Secondary:   Myocardial Contractility   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 11

12.  Secondary:   Myocardial Contractility-LV Ejection Time   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 12

13.  Secondary:   Myocardial Contractility-DT   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 13

14.  Secondary:   Myocardial Contractility-SBP   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 14

15.  Secondary:   Myocardial Contractility-DBP   [ Time Frame: Baseline and week 16 ]
  Show Outcome Measure 15


  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
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.


  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:
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