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

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ClinicalTrials.gov Identifier: NCT00656851
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : August 20, 2013
Last Update Posted : August 28, 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: Diagnostic
Conditions HIV Infections
Cardiovascular Disease
Insulin Resistance
HIV Lipodystrophy
The Metabolic Syndrome
Interventions Drug: Pioglitazone
Behavioral: Exercise Training
Enrollment 24
Recruitment Details 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 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.
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description Pioglitazone (Actos, 30mg/day for 16 weeks) Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Period Title: Overall Study
Started 12 12
Completed 12 8
Not Completed 0 4
Reason Not Completed
Withdrawal by Subject             0             4
Arm/Group Title Pioglitazone Exercise Training Total
Hide Arm/Group Description Pioglitazone (Actos, 30mg/day for 16 weeks) Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
42  (7) 41  (6) 42  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
3
  25.0%
0
   0.0%
3
  12.5%
Male
9
  75.0%
12
 100.0%
21
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Myocardial Glucose Utilization Rate
Hide Description Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate. The rate at which glucose exits the blood, enters the muscle cells in the left ventricle, and is metabolized (ATP generation, glycolysis, glycogenolysis, or lactate production). Total glucose utilization rate in the left ventricle of the heart.
Time Frame Weeks 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: (nmol glucose/g heart muscle/min
Week 0 109.6  (70.5) 106.7  (69.0)
Week 16 109.1  (55.2) 87.2  (97.4)
2.Primary Outcome
Title Myocardial Glucose Utilization Rate Per Unit Insulin
Hide Description Radio-tracer (11C-glucose) and positron emission tomography quantification of myocardial glucose utilization rate per unit of plasma insulin. Total glucose utilization rate in the left ventricle of the heart expressed per unit of the circulating plasma insulin concentration.
Time Frame Weeks 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: (nmol glucose/g heart muscle/min/µU insu
Week 0 14.9  (22.1) 11.9  (11.0)
Week 16 15.7  (12.4) 21.7  (40.8)
3.Primary Outcome
Title Myocardial Fatty Acid Utilization Rate
Hide Description Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid utilization rate. The rate at which palmitate exits the blood, enters the muscle cells in the left ventricle, and is metabolized (oxidation, re-esterification).
Time Frame Weeks 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: (nmol palmitate/g heart muscle/min
Week 0 119.3  (39.8) 119.8  (48.7)
Week 16 129.3  (34.5) 130.4  (55.2)
4.Primary Outcome
Title Myocardial Fatty Acid Oxidation Rate
Hide Description Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid oxidation rate.
Time Frame Weeks 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: (nmol palmitate/g heart muscle/min
Week 0 92.4  (27.5) 106.3  (49.6)
Week 16 110.1  (31.7) 97.5  (36.6)
5.Primary Outcome
Title Myocardial Fatty Acid Esterification
Hide Description Radio-tracer (11C-palmitate) and positron emission tomography quantification of myocardial fatty acid esterification as a % of total fatty acid extraction
Time Frame Weeks 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: (% of total fatty acid extraction)
Week 0 7  (7) 4  (3)
Week 16 4  (5) 7  (5)
6.Secondary Outcome
Title Myocardial Contractile Function During Diastole
Hide Description

Echocardiographic quantification of (E/A) early to late diastolic filling velocity. Aria transfer blood to the ventricles in 2 steps:

  1. blood collected in the atria falls into the ventricles when the atrioventricular valves opens. In the left heart, the velocity at which the blood moves during this initial action is called the early or "E" filling velocity.
  2. residual blood in the atria, is emptied during diastole by atrial contraction. The velocity of the blood during atrial contraction is the "A" (for atrial) filling velocity. These are expressed as a ratio (E/A). If A exceeds E velocity (ratio <1.0) this is a clinical marker of diastolic dysfunction. This can occur when the left ventricular wall becomes so stiff as to impair proper filling, which can lead to diastolic heart failure.
Time Frame Weeks 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: ratio
Week 0 1.4  (0.6) 1.4  (0.3)
Week 16 1.4  (0.5) 1.5  (0.2)
7.Secondary Outcome
Title Myocardial Contractile Function During Systole
Hide Description Echocardiographic quantification of E' wall velocity during systole averaged at the lateral wall and septum
Time Frame Weeks 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: cm/sec
Week 0 12.7  (1.8) 13.1  (2.4)
Week 16 12.8  (1.6) 13.6  (0.4)
8.Secondary Outcome
Title Fasting Lipids and Lipoproteins
Hide Description fasting serum triglycerides, LDL-, and HDL-cholesterol concentrations
Time Frame Week 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: mg/dL
triglycerides wk 0 199  (119) 185  (58)
triglycerides wk 16 182  (91) 159  (33)
LDL-cholesterol wk 0 115  (36) 112  (26)
LDL-cholesterol wk 16 97  (17) 90  (24)
HDL-cholesterol wk 0 38.9  (11.0) 38.1  (8.4)
HDL-cholesterol wk 16 38.8  (12.4) 39.8  (21.8)
9.Secondary Outcome
Title Fasting Glucose Insulin and HOMA
Hide Description fasting plasma glucose, insulin concentrations and HOMA-insulin resistance
Time Frame Week 0 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description:
Pioglitazone (Actos, 30mg/day for 16 weeks)
Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
Overall Number of Participants Analyzed 12 8
Mean (Standard Error)
Unit of Measure: mg/dL µU/mL
glucose (mg/dL) wk 0 102  (15) 91.9  (9.5)
glucose wk 16 95.3  (13) 86.8  (8.2)
insulin (µU/mL) wk 0 20.5  (25.7) 14.8  (8.4)
insulin wk 16 11.4  (9.6) 11.8  (7.6)
HOMA-IR wk 0 6.1  (10.4) 3.3  (1.7)
HOMA-IR wk 16 2.8  (2.7) 2.6  (1.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pioglitazone Exercise Training
Hide Arm/Group Description Pioglitazone (Actos, 30mg/day for 16 weeks) Cardiorespiratory and resistance exercise training 3days/wk for 16 weeks
All-Cause Mortality
Pioglitazone Exercise Training
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone Exercise Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Pioglitazone Exercise Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/8 (0.00%) 
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.
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
EMail: key@wustl.edu
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