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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT01537094
Eligibility Criteria:
Inclusion Criteria:
1. Men and women age 18-60
2. BMI ≥ 30 kg/m2
3. Waist circumference ≥ 102 cm in men and ≥ 88 cm in women
4. Plasma vitamin C concentration ≤ 23 µmol/l
5. Peak stimulated GH ≤ 4.2 µg/l upon GHRH-arginine stimulation test
Exclusion Criteria:
1. History of hypopituitarism, pituitary surgery, pituitary/brain radiation, recent traumatic brain injury or any other condition known to affect the GH axis.
2. History of severe chronic illness including anemia, chronic kidney disease, liver disease, oxygen dependent COPD or HIV
3. Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment
4. Use of dietary supplements including vitamin C or once daily multi-vitamins
5. Subjects with Hgb \< 912 g/dL, SGOT \> 2.5x upper limit of normal or Creatinine \> 1.5 mg/dL
6. Subjects with poorly controlled diabetes, defined as HbA1c \> 8%.
7. Changes in lipid lowering or anti-hypertensive regimen within 3months of screening
8. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
9. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01537094
Study Brief:
Protocol Section:
NCT01537094