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Exercise and Pioglitazone for HIV-Metabolic Syndromes

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: NCT00639457
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : September 12, 2013
Last Update Posted : October 23, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV Infections
Type 2 Diabetes
Cardiovascular Disease
Interventions: Drug: Pioglitazone
Behavioral: Exercise training

  Participant Flow

  Baseline Characteristics

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
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.
Total Total of all reporting groups

Baseline Measures
   Pioglitazone   Pioglitazone + Exercise Training   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   44 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   22   22   44 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 44  (2)   46  (2)   45  (2) 
[Units: Participants]
Female   3   2   5 
Male   19   20   39 
Region of Enrollment 
[Units: Participants]
United States   22   22   44 

  Outcome Measures

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 ]

  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