Trial Outcomes & Findings for Effects of Pioglitazone on Exogenous Carbohydrate Oxidation During Steady-State Exercise at High Altitude (NCT NCT06164665)
NCT ID: NCT06164665
Last Updated: 2026-03-19
Results Overview
Determine the effects of PIO on exogenous glucose oxidation (g/min) during exercise under acute HA exposure compared to PLA
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
8 hours
Results posted on
2026-03-19
Participant Flow
Participant milestones
| Measure |
Pioglitazone First, Then Placebo
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
Followed by:
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
|
Placebo First, Then Pioglitazone
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
followed by;
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
|
|---|---|---|
|
First Intervention (5 days)
STARTED
|
4
|
4
|
|
First Intervention (5 days)
COMPLETED
|
3
|
4
|
|
First Intervention (5 days)
NOT COMPLETED
|
1
|
0
|
|
Washout (2 weeks)
STARTED
|
3
|
4
|
|
Washout (2 weeks)
COMPLETED
|
3
|
4
|
|
Washout (2 weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (5 days)
STARTED
|
3
|
4
|
|
Second Intervention (5 days)
COMPLETED
|
3
|
4
|
|
Second Intervention (5 days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pioglitazone First, Then Placebo
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
Followed by:
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
|
Placebo First, Then Pioglitazone
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
followed by;
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
|
|---|---|---|
|
First Intervention (5 days)
Adverse Event
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pioglitazone First, Then Placebo
n=4 Participants
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
Followed by:
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
|
Placebo First, Then Placebo
n=4 Participants
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
Followed by:
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
22 years
STANDARD_DEVIATION 4 • n=4 Participants
|
26 years
STANDARD_DEVIATION 8 • n=4 Participants
|
23 years
STANDARD_DEVIATION 6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
4 participants
n=4 Participants
|
8 participants
n=8 Participants
|
|
High Altitude VO2peak
|
31 ml/kg/min
STANDARD_DEVIATION 2 • n=4 Participants
|
35 ml/kg/min
STANDARD_DEVIATION 4 • n=4 Participants
|
33 ml/kg/min
STANDARD_DEVIATION 3 • n=8 Participants
|
PRIMARY outcome
Timeframe: 8 hoursDetermine the effects of PIO on exogenous glucose oxidation (g/min) during exercise under acute HA exposure compared to PLA
Outcome measures
| Measure |
Pioglitazone
n=7 Participants
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
|
Placebo
n=7 Participants
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
|
|---|---|---|
|
Rate of Exogenous Glucose Oxidation
|
0.31 g/min
Standard Deviation 0.03
|
0.32 g/min
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 8 hoursDetermine the effects of PIO on inflammation during acute HA exposure compared to PLA.
Outcome measures
| Measure |
Pioglitazone
n=7 Participants
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
|
Placebo
n=7 Participants
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
|
|---|---|---|
|
Concentration of Interleukin-6
|
2.51 pg/mL
Standard Deviation 0.61
|
2.57 pg/mL
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: 8 hoursDetermine the effects of PIO on markers of iron status during acute HA exposure compared to PLA
Outcome measures
| Measure |
Pioglitazone
n=7 Participants
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
|
Placebo
n=7 Participants
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
|
|---|---|---|
|
Concentration of Serum Hemoglobin
|
15.2 g/dL
Standard Deviation 0.8
|
15.0 g/dL
Standard Deviation 0.6
|
Adverse Events
Pioglitazone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pioglitazone
n=8 participants at risk
Pioglitazone administered as a 15 mg oral dose per day for 5 days
Pioglitazone 15mg: Pioglitazone (PIO) will be administered as a 15 mg oral dose per day for 5 days
|
Placebo
n=7 participants at risk
Microcrystalline cellulose pill administered as an oral dose per day for 5 days
Placebo: 100% microcrystalline cellulos
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 8 hours
|
0.00%
0/7 • 8 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place