Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT02447835
Eligibility Criteria:
Inclusion Criteria:
1. Men and women ages 18-40
2. BMI 19-24.5kg/m2
3. Systolic BP \<130mm Hg
4. Diastolic BP \<85mm Hg
5. Subjects capable of giving informed consent, with no past or present psychiatric history
6. Only women on oral contraceptives with constant dosing regimens or Depo-Provera for \>3 months, to ensure uniform hormonal delivery throughout the study duration
7. No medications except as above noted
8. Weight stable
9. Minimal exercise regime that includes walking, running or biking
Exclusion Criteria:
1. History of heart disease, colitis, autonomic neuropathy, hepatic or renal disease
2. DSM-IV diagnosis of past or present psychiatric history, including clinically significant depression
3. Drug/Alcohol dependence, homelessness, or inability to give informed consent
4. History of asthma, congenital obstructive bladder, peptic ulcer, vasomotor instability, epilepsy, Parkinsonism, elevated thyroid hormone levels
5. Diagnosis of diabetes
6. BMI\>25 kg/m2
7. Prescription medication (excluding the contraceptive methods described above)
8. Hemoglobin \<11
9. Abnormal laboratory tests which are clinically significant per the investigator
10. Females pregnant or lactating
11. Females: not taking hormonal contraceptives; taking hormonal contraceptives of varying dosage throughout the month
12. Currently on a weight loss diet
13. Moderate to significant exercise regime that includes swimming, weight lifting or other form of exercise not reproducible within CTRC.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT02447835
Study Brief:
Protocol Section:
NCT02447835