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NCT07668622
Aerobic Exercise as a Countermeasure for Night Shift Associated Circadian Misalignment
Conditions: Healthy, Circadian Misalignment
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 16
Sponsor: University of Colorado, Denver
Location: University of Colorado Anschutz Medical Campus Aurora Colorado
Summary
This study plans to learn more about whether exercise can help protect the body from health problems that happen when a person's sleep and daily schedule are out of sync with their natural body clock (circadian rhythm).
Eligibility Criteria
Inclusion Criteria:
* Age 18-40 years
* Body Mass Index 18.5-\160 mmHG, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position.
* Diabetes (fasting glucose \>/=126 mg/dL or Hemoglobin A1C \>/=6.5%) as measured during the screening visit.
* Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
* Triglycerides \>400 mg/dL as measured on the screening visit.
* LDL cholesterol \>200 mg/dL as measured on the screening visit.
* Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects.
* Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to participate in exercise: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease.
* Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease.
* Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
* Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
* Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
* Regular use of systemic steroids (other than Oral Contraceptive Pills).
* Regular use of obesity pharmacotherapeutic agents within the last 6 months.
* Current alcohol or substance abuse.
* Nicotine use (past 6 months).
* Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score \> 16 on the Center for Epidemiologic Studies Depression Scale (CES-D) will require further assessment by the Study MD to determine if it is appropriate for the subject to participate
* History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the study conditions.
* Weight loss \>5% in past 3 months.
* Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.
* Primary sleep disorders including but not limited to insomnia, obstructive sleep apnea, periodic limb movements in sleep, restless leg syndrome.
* Night-time shiftwork, rotating work, or other circadian disruptions and disorders (e.g., diagnosed delayed sleep-wake phase disorder).
* Self-reported long (\>9.25h) or short sleep (\/=2 days per week).
* High consumption of caffeine (\>500 mg/d) or unwilling to abstain from caffeine consumption during run-in and in-patient protocol.
* Planned travel \>1 time zone away 4 weeks prior to study start or at any time during study protocol.
Source: ClinicalTrials.gov (NCT07668622). StuddyBuddy aggregates publicly available trial information.