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 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT00397592
Eligibility Criteria:
Inclusion Criteria:
* Adults age 18 thru 65
* Serum IGF-1 in the lower half of the age and gender-specific normal range at the time of screening visit
Exclusion Criteria:
* Systemic hypertension, as defined as current BP \>140/90 on screening visit, or taking anti-hypertensive therapy.
* Diabetes mellitus, as defined by known diagnosis or Fasting Blood Glucose \>126 at the time of screening visit.
* Women who are pregnant or nursing, as confirmed by history or seum beta-hCG at the time of screening visit.
* Women who are taking exogenous oral estrogens of any kind.
* Personal history of active cancer or recurrence within the past 10 years, with the exception of non-melanoma skin cancer.
* Personal history of an untreated benign intracranial neoplasm.
* Initiation of statin therapy during the course of the study.
* A serum IGF-1 level below the age and gender-specific normal range at the time of screening visit.
* Renal insufficiency, as defined by a GFR \<60 mls/min/1.73 m2 upon Renal Function panel at the time of screening visit.
* Hepatic insufficiency, as defined by an AST and/or ALT \>twice the upper limit of normal at the time of screening visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00397592
Study Brief:
Protocol Section:
NCT00397592