Status:
COMPLETED
Effects of Pioglitazone on Exogenous Carbohydrate Oxidation During Steady-State Exercise at High Altitude
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Conditions:
High Altitude
Eligibility:
MALE
18-39 years
Phase:
PHASE4
Brief 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 i...
Detailed Description
This randomized crossover placebo controlled double blinded study will examine substrate oxidation and glucose kinetic responses to ingesting supplemental carbohydrate (glucose) during metabolically-m...
Eligibility Criteria
Inclusion
- Men aged 18 - 39 years
- Born at altitudes less than 2,100 m
- Physically active (exercise minimum 2 days per week)
- Have supervisor approval (permanent party military and civilians)
- Willing to refrain from alcohol, smokeless nicotine products and dietary supplement use during study periods
- Fully vaccinated against COVID-19
Exclusion
- Born at altitudes greater than 2,100 m
- Musculoskeletal injuries that compromise exercise capability
- Metabolic or cardiovascular abnormalities, or gastrointestinal disorders
- Taking medication that affects macronutrient metabolism and/or the ability to participate in strenuous exercise
- Living in areas that are more than 1,200 m, or traveled to areas that are more than 1,200 m for five days or more within 2 months of data collection
- Evidence of apnea or other sleeping disorders
- Prior diagnosis of high altitude pulmonary edema or high altitude cerebral edema
- Presence of asthma or respiratory tract infections
- Smoking or vaping
- Taking medications that interfere with oxygen delivery and transport
- Anemia (HCT \<38% and HBG \<12.5 g/dL) and Sickle Cell Anemia/Trait
- Blood donation within 8 weeks of beginning the study
- Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
- Unwilling or unable to adhere to study physical restrictions
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06164665
Start Date
March 1 2023
End Date
July 1 2023
Last Update
December 11 2023
Active Locations (1)
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1
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, United States, 01760