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NCT06164665 · ClinicalTrials.gov registry record · Phase 4
Effects of Pioglitazone on Exogenous Carbohydrate Oxidation During Steady-State Exercise at High Altitude
A Phase 4 study, sponsored by United States Army Research Institute of Environmental Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT06164665: Completed Phase 4 study, sponsored by United States Army Research Institute of Environmental Medicine.
NCT06164665 is a Phase 4 study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06164665, a Phase 4 study, has completed, sponsored by United States Army Research Institute of Environmental Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
Apparent hypoxia-induced insulin insensitivity along with alterations in glucose kinetics suggests reduction in glucose uptake by the peripheral tissue is a primary factor contributing to reductions in exogenous glucose oxidation at HA. As such, the primary objective of this study is to determine the ability of an insulin sensitizer (Pioglitazone, PIO) to enhance exogenous glucose oxidation and metabolic clearance rate during metabolically-matched, steady-state exercise during acute HA exposure compared to placebo (PLA) in native lowlanders. Secondary objective of this study will be to assess the impact of PIO on markers of inflammation and iron status compared to PLA. This randomized crossover placebo control double blinded study will examine substrate oxidation and glucose kinetic responses to ingesting supplemental carbohydrate (glucose) during metabolically-matched, steady-state exercise with acute (\~5 h) exposure to HA (460 mmHg, or 4300m, barometric pressure similar to Pike's Peak) after receiving PIO (HA+PIO), or after receiving a matched placebo (HA+PLA). Eight healthy, recreationally active males between the ages of 18-39 yrs will be required to complete this study. Following a 4 day glycogen normalization period receiving PIO or PLA daily, volunteers will complete two 80-min trials, performing metabolically-matched, steady-state aerobic (same absolute workload corresponding to \~55 ± 5% of V̇O2peak at HA) exercise on a treadmill, and consuming 145 g of glucose (1.8 g/min); one trial with HA+PIO and the other with HA+PLA. A dual glucose tracer (13C-glucose oral ingestion and \[6,6-2H2\]-glucose primed, continuous infusion) technique and indirect calorimetry will be used to selectively analyze endogenous and exogenous glucose oxidation, as well as glucose rate of appearance (Ra), disappearance (Rd) and metabolic clearance rate (MCR). Serial blood samples will be collected during each trial to assess endocrine and circulating substrate responses to exercise,
Primary Outcome
Determine the effects of PIO on exogenous glucose oxidation (g/min) during exercise under acute HA exposure compared to PLA
Interventions
- OTHER Placebo
- DRUG Pioglitazone 15mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2023-07-01 |
| Phase | Phase 4 |
What the finished NCT06164665 record still lists
NCT06164665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06164665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06164665 about?
NCT06164665 is a clinical study titled "Effects of Pioglitazone on Exogenous Carbohydrate Oxidation During Steady-State Exercise at High Altitude". Apparent hypoxia-induced insulin insensitivity along with alterations in glucose kinetics suggests reduction in glucose uptake by the peripheral tissue is a primary factor contributing to reductions in exogenous glucose oxidation at HA. As such, the primary objective of this study is to determine th...
What is the current status of trial NCT06164665?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2023-03-01. Estimated completion is 2023-07-01.
What interventions are being tested in trial NCT06164665?
The interventions under investigation include: Placebo (OTHER), Pioglitazone 15mg (DRUG).
Who is sponsoring clinical trial NCT06164665?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06164665's enrollment target sits among peer trials
9 1968th of 2000 higher than 29 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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