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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT01155518
Eligibility Criteria:
Inclusion Criteria:
* T2D Males with age 18-40 years
Exclusion Criteria:
1. planning to have children in the next one year
2. Use of androgens, CC, hCG, aromatase inhibitors or over the counter health supplements which contain androgens currently or in the past 6 months;
3. PSA \> 4ng/ml, symptoms of severe BPH, prostate nodule or severe enlargement on digital rectal examination or h/o prostatic carcinoma
4. Hemoglobin A1c \> 8%
5. Hematocrit \> 50%
6. History of obstructive sleep apnea
7. Congestive heart failure
8. Use of thiazolidinediones or exenatide
9. currently suffering from depression, with or without treatment
10. history of severe depression in the past which needed hospitalization
11. currently suffering from foot ulcer, significant periodontal disease or any other chronic infectious condition
12. Coronary event or procedure in the previous 6 months
13. Hepatic disease (transaminase \> 3 times normal) or cirrhosis
14. Renal impairment (serum creatinine \> 1.5)
15. HIV or Hepatitis C positive status
16. Participation in any other concurrent clinical trial
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT01155518
Study Brief:
Protocol Section:
NCT01155518