Phase
Condition
Obesity
Diabetes Prevention
Treatment
Normobaric hypoxia (NH)
Normobaric normoxia (NN)
Clinical Study ID
Ages 22-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 14days before any in-person human research activity.
Not taking any medication(s) that interfere with oxygen delivery/transport for 4weeks prior to and throughout the entire study (e.g., includes sedatives, sleepingaids, tranquilizers and/or any medication that depresses ventilation, diuretics,alpha and beta blockers).
Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement usethroughout the entire study.
Willing to have a hypoxic tent set-up in their home and spend 8 consecutive hoursper night in the tent for 8 weeks
Lives with a family member, partner/spouse, or roommate who can hear and respond inthe unlikely event that the blood oxygen, air oxygen, or air carbon dioxidemonitoring alarm would sound.
Exclusion
Exclusion Criteria:
Living in areas that are more than 1,200 m (~4,000 feet), or have traveled to areasthat 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-19vaccination series at least 14 days before any in-person human research activity.
Cardiovascular abnormalities, gastrointestinal disorders, or any condition thatinterferes with oxygen delivery/transport (e.g., kidney disease, cardiovasculardisease, etc.)
Oxygen saturation < 95% while awake or oxygen saturation dips below 88% for a totalof ≥ 10 min overnight in normoxic conditions
Evidence of apnea or other sleeping disorders
Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebraledema (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 anirregular menstrual cycle in the past 6 mo.
Weight gain or loss > 10% of body weight during the past 6 months
Adults unable to consent
Study Design
Study Description
Connect with a study center
Florida State University
Tallahassee, Florida 32306
United StatesSite Not Available
Pennington Biomedical Research Center
Baton Rouge, Louisiana 70808
United StatesActive - Recruiting
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