Status:
RECRUITING
Low Oxygen Exposure and Weight Status
Lead Sponsor:
Pennington Biomedical Research Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
The objective of the proposed double-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance (intake and expenditure...
Detailed Description
Obesity and associated metabolic conditions are a significant public health burden, costing the U.S. \~$150 billion annually. Obesity is both a disease, affecting 1 in 3 Americans, and a risk factor f...
Eligibility Criteria
Inclusion
- Obese (BMI between 30-39.9 kg/m2)
- Born at altitudes below 2,100 meters (\~7,000 feet)
- Currently residing in Tallahassee, Florida or surrounding area
- Completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
- Not taking any medication(s) that interfere with oxygen delivery/transport for 4 weeks prior to and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers and/or any medication that depresses ventilation, diuretics, alpha and beta blockers).
- Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study.
- Willing to have a hypoxic tent set-up in their home and spend 8 consecutive hours per night in the tent for 8 weeks
- Lives with a family member, partner/spouse, or roommate who can hear and respond in the unlikely event that the blood oxygen, air oxygen, or air carbon dioxide monitoring alarm would sound.
Exclusion
- Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
- Individuals who have not completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
- Cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with oxygen delivery/transport (e.g., kidney disease, cardiovascular disease, etc.)
- Oxygen saturation \< 95% while awake or oxygen saturation dips below 88% for a total of ≥ 10 min overnight in normoxic conditions
- Evidence of apnea or other sleeping disorders
- Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
- Diagnosis or family history of sickle cell anemia/trait
- Hematocrit \<42% for males, \<36% for females
- Hemoglobin \<13 g/dL for males, \<12 g/dL for females
- Blood donation within 8 weeks of beginning the study
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past 6 mo.
- Weight gain or loss \> 10% of body weight during the past 6 months
- Adults unable to consent
Key Trial Info
Start Date :
May 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05289310
Start Date
May 16 2023
End Date
April 30 2027
Last Update
March 17 2025
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808