Trial Outcomes & Findings for Exercise and Pioglitazone for HIV-Metabolic Syndromes (NCT NCT00639457)
NCT ID: NCT00639457
Last Updated: 2013-10-23
Results Overview
Insulin-mediated glucose disposal rate per kg of fat free mass per min
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Baseline and week16
Results posted on
2013-10-23
Participant Flow
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.
Exclusion: AIDS diagnosis, non-compliant with anti-HIV medications, unstable CD4+ T-cell count or plasma HIV viremia, illegal drug abuse.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Exercise and Pioglitazone for HIV-Metabolic Syndromes
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=22 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=22 Participants
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
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
44 years
STANDARD_DEVIATION 2 • n=5 Participants
|
46 years
STANDARD_DEVIATION 2 • n=7 Participants
|
45 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week16Insulin-mediated glucose disposal rate per kg of fat free mass per min
Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Insulin-stimulated Glucose Disposal Rate
Baseline
|
30 µmol glucose/kg FFM/min
Standard Error 4
|
34 µmol glucose/kg FFM/min
Standard Error 4
|
|
Insulin-stimulated Glucose Disposal Rate
Week 16
|
37 µmol glucose/kg FFM/min
Standard Error 6
|
48 µmol glucose/kg FFM/min
Standard Error 6
|
SECONDARY outcome
Timeframe: Baseline and week 16Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Visceral Fat Volume
Baseline
|
1933 cm3
Standard Error 150
|
1890 cm3
Standard Error 217
|
|
Visceral Fat Volume
Week 16
|
1970 cm3
Standard Error 164
|
1746 cm3
Standard Error 177
|
SECONDARY outcome
Timeframe: Baseline and week 16Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Abdominal Subcutaneous Fat Volume
Baseline
|
2101 cm3
Standard Error 293
|
1877 cm3
Standard Error 197
|
|
Abdominal Subcutaneous Fat Volume
Week 16
|
2164 cm3
Standard Error 286
|
1905 cm3
Standard Error 230
|
SECONDARY outcome
Timeframe: Baseline and week 16Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Hepatic Lipid Content
Baseline
|
12.1 percent of water
Standard Error 2.0
|
8.0 percent of water
Standard Error 1.7
|
|
Hepatic Lipid Content
Week 16
|
10.7 percent of water
Standard Error 2.4
|
5.5 percent of water
Standard Error 0.8
|
SECONDARY outcome
Timeframe: Baseline and week 16ability of insulin to suppress hepatic glucose production = hepatic insulin sensitivity
Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Hepatic Glucose Production Rate
Baseline
|
32 percent suppression
Standard Error 3
|
37 percent suppression
Standard Error 5
|
|
Hepatic Glucose Production Rate
Week 16
|
40 percent suppression
Standard Error 6
|
42 percent suppression
Standard Error 7
|
SECONDARY outcome
Timeframe: Baseline and week 16Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Serum Lipid and Lipoprotein Levels
Baseline Triglycerides
|
2.3 mM/L
Standard Error 0.3
|
2.1 mM/L
Standard Error 0.4
|
|
Serum Lipid and Lipoprotein Levels
Week 16 Triglycerides
|
2.5 mM/L
Standard Error 0.3
|
1.8 mM/L
Standard Error 0.2
|
|
Serum Lipid and Lipoprotein Levels
Baseline Total Cholesterol
|
4.9 mM/L
Standard Error 0.2
|
4.7 mM/L
Standard Error 0.2
|
|
Serum Lipid and Lipoprotein Levels
Week 16 Total cholesterol
|
4.6 mM/L
Standard Error 0.2
|
4.5 mM/L
Standard Error 0.2
|
|
Serum Lipid and Lipoprotein Levels
Baseline LDL cholesterol
|
2.8 mM/L
Standard Error 0.2
|
2.7 mM/L
Standard Error 0.2
|
|
Serum Lipid and Lipoprotein Levels
Week 16 LDL cholesterol
|
2.5 mM/L
Standard Error 0.1
|
2.6 mM/L
Standard Error 0.2
|
|
Serum Lipid and Lipoprotein Levels
Baseline HDL cholesterol
|
0.99 mM/L
Standard Error 0.05
|
1.06 mM/L
Standard Error 0.05
|
|
Serum Lipid and Lipoprotein Levels
Week 16 HDL cholesterol
|
0.98 mM/L
Standard Error 0.05
|
1.09 mM/L
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and week 16Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Liver Enzyme Levels
Baseline ALT
|
38 U/L
Standard Error 7
|
34 U/L
Standard Error 6
|
|
Liver Enzyme Levels
Week 16 ALT
|
39 U/L
Standard Error 8
|
32 U/L
Standard Error 6
|
|
Liver Enzyme Levels
Baseline AST
|
34 U/L
Standard Error 7
|
27 U/L
Standard Error 4
|
|
Liver Enzyme Levels
Week 16 AST
|
30 U/L
Standard Error 4
|
27 U/L
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline and Week 16Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Hemoglobin
Baseline Hemoglobin
|
13.8 g/L
Standard Error 0.3
|
13.8 g/L
Standard Error 0.5
|
|
Hemoglobin
Week 16 Hemoglobin
|
13.7 g/L
Standard Error 0.3
|
13.6 g/L
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline and Week 16Percentage of blood volume that is red cells
Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Hematocrit
Baseline Hematocrit
|
39.9 % red cells
Standard Error 0.7
|
40.7 % red cells
Standard Error 1.4
|
|
Hematocrit
Week 16 Hematocrit
|
39.6 % red cells
Standard Error 0.7
|
39.7 % red cells
Standard Error 1.3
|
SECONDARY outcome
Timeframe: Baseline and week 16Outcome measures
| Measure |
Pioglitazone
n=20 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=19 Participants
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.
|
|---|---|---|
|
Serum Adiponectin Levels
Baseline serum adiponectin
|
4.7 µg/mL
Standard Error 0.8
|
4.8 µg/mL
Standard Error 0.8
|
|
Serum Adiponectin Levels
Week 16 serum adiponectin
|
7.0 µg/mL
Standard Error 0.7
|
6.5 µg/mL
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after \~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.
E/A ratio; ratio of the early (E) to late (A) ventricular filling velocities
Outcome measures
| Measure |
Pioglitazone
n=11 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=10 Participants
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.
|
|---|---|---|
|
Myocardial Contractility
Baseline E/A ratio
|
1.3 ratio
Standard Error 0.2
|
1.2 ratio
Standard Error 0.1
|
|
Myocardial Contractility
Week 16 E/A ratio
|
1.4 ratio
Standard Error 0.2
|
1.4 ratio
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after \~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.
Time required to empty the left ventricle into the aorta
Outcome measures
| Measure |
Pioglitazone
n=11 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=10 Participants
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.
|
|---|---|---|
|
Myocardial Contractility-LV Ejection Time
Baseline LV ejection time
|
296 msec
Standard Error 8
|
281 msec
Standard Error 12
|
|
Myocardial Contractility-LV Ejection Time
Week 16 LV ejection time
|
294 msec
Standard Error 9
|
305 msec
Standard Error 9
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after \~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.
Deceleration time; time from the peak of early diastolic filling to baseline
Outcome measures
| Measure |
Pioglitazone
n=11 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=10 Participants
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.
|
|---|---|---|
|
Myocardial Contractility-DT
Baseline DT
|
204 msec
Standard Error 7
|
214 msec
Standard Error 12
|
|
Myocardial Contractility-DT
Week 16 DT
|
193 msec
Standard Error 6
|
190 msec
Standard Error 4
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after \~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.
Systolic blood pressure; peak vascular pressure during ventricular contraction
Outcome measures
| Measure |
Pioglitazone
n=11 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=10 Participants
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.
|
|---|---|---|
|
Myocardial Contractility-SBP
Baseline SBP
|
114 mmHg
Standard Error 2
|
121 mmHg
Standard Error 4
|
|
Myocardial Contractility-SBP
Week 16 SBP
|
114 mmHg
Standard Error 2
|
114 mmHg
Standard Error 3
|
SECONDARY outcome
Timeframe: Baseline and week 16Population: Number of participants for measures of myocardial contractility is less than that for all other measures. These measures were added to the protocol (after \~50% enrollment) after some reports suggested that this drug class (thiazolidinediones) may adversely affect heart function.
Diastolic blood pressure; vascular pressure during ventricular relaxation (diastole)
Outcome measures
| Measure |
Pioglitazone
n=11 Participants
Pioglitazone (Actos; 30mg/day) for 16 weeks.
|
Pioglitazone + Exercise Training
n=10 Participants
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.
|
|---|---|---|
|
Myocardial Contractility-DBP
Baseline DBP
|
65 mmHg
Standard Error 3
|
68 mmHg
Standard Error 5
|
|
Myocardial Contractility-DBP
Week 16 DBP
|
67 mmHg
Standard Error 4
|
61 mmHg
Standard Error 4
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pioglitazone + Exercise Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place