治験レーダー

• Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures.
• No contraindications to exercise or limitations on ability to be physically active.
• Ability to complete AM or PM exercise and complete 4 exercise sessions per week.
• Ability to adhere to eating and exercise protocols (meal timing, exercising in fasted and fed states)
• Willing and able to wear activity/sleep monitor for 7 consecutive days.
• Willing not to enroll in any other formal weight loss or physical activity programs over the next 6 months.
• For Females:
• Not currently pregnant or lactating.
• Not pregnant within the past 6 months.
• Not planning to become pregnant in the next 6 months

Exclusion Criteria:

• Diastolic blood pressure >100 mmHG, systolic blood pressure >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.
• Hematocrit, white blood cell count or platelets significantly outside the normal reference range as measured on the screening visit.
• 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).
• Use of medications that would impact ability to achieve age-predicted maximum heart rate (e.g. beta blockers).
• 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 exercise 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 (<7h) that would make adhering the exercise conditions difficult.
• Regular use of prescription or over-the-counter medications known to affect sleep (e.g., benzodiazepines, doxepin, zolpidem, trazodone, diphenhydramine HCl, etc.).
• Regular use of melatonin (>/=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.