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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01853332
Eligibility Criteria:
Inclusion Criteria:
* Male and female participants between 35 and 55 years of age.
Exclusion Criteria: (based on interference with key assessments)
* Abnormal hepatic function (liver function tests \>2X upper normal);
* abnormal renal function (creatinine \>1.3 mg/dl);
* conditions/illnesses such as active infection, significant malabsorption/malnutrition, cancer;
* active hormonal disease such as overt hypo/hyperthyroidism, hypogonadism, hyper-cortisolism, or treatment with steroids or growth hormone.
* Known Diabetes Mellitus (DM) and Cardiovascular Disease (CVD) will be screened for by a detailed history and systems review.
* Baseline laboratory analysis with chemistries, CBC, hormone levels, and EKG will be completed.
Two exceptions will be made to the usual exclusion criteria:
1. Original subjects with DM or CVD will not be excluded, since that would result in bias in that sample and loss of opportunity to examine predictors associated with these outcomes.
2. Community adults diagnosed with these disorders at the screening visit will be retained and referred for medical treatment as needed. In both groups, those with DM and/or CVD will be followed for psychosocial and relevant biomedical variables, excluding assessments interfered with by CVD and DM relevant medications. Those with DM and CVD will at times be separately analyzed, together with participants who develop these disorders in the years of this new study phase.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
55 Years
Study:
NCT01853332
Study Brief:
Protocol Section:
NCT01853332