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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT02034435
Eligibility Criteria:
Inclusion Criteria:
1. Ambulatory subjects, 18 to 70 years of age, inclusive
2. For female subjects, the following conditions must be met:
1. postmenopausal status for at least 1 year, or
2. status-post surgical sterilization, or
3. if of childbearing potential, utilization of adequate birth control and willingness to undergo urine beta-hcg testing prior to drug treatment and on every study day.
3. Metabolic Syndrome as defined by the presence of \> 3 of the following:
1. Systolic Blood Pressure \> 130 mm Hg OR Diastolic Blood Pressure \> 85 mm Hg.
2. Glucose Intolerance (Fasting Plasma Glucose ≥ 100 mg/dL)
3. Increased triglyceride level \> 150mg/dL (1.7mmol/L)
4. Decreased levels of HDL cholesterol (For males, less than 40 mg/dL; For females, less than 50 mg/dL)
5. Waist circumference (For males, greater than 40 inches; For females, greater than 35 inches)
Exclusion Criteria:
1. type 1 Diabetes
2. Type II Diabetes
3. Impaired renal function
4. Prior allergies to medications used in the study protocol
5. Screening plasma potassium \>5.5 mmol/L or sodium \<135 mmol/L
6. Cardiovascular disease
7. Use of hormone replacement therapy
8. Breast-feeding
9. Treatment with anticoagulants
10. History of serious neurologic disease
11. History or presence of immunological or hematological disorders
12. Diagnosis of asthma requiring use of inhaled beta agonist
13. Clinically significant gastrointestinal impairment
14. Impaired hepatic function
15. Hematocrit \<35%
16. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult, such as arthritis treated with non-steroidal antiinflammatory drugs
17. Treatment with chronic systemic glucocorticoid therapy
18. Treatment with lithium salts
19. History of alcohol or drug abuse
20. Treatment with any investigational drug in the 1 month preceding
21. Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
22. Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02034435
Study Brief:
Protocol Section:
NCT02034435