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 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT00484861
Eligibility Criteria:
* INCLUSION CRITERIA:
African American Women: Individuals will be considered to be African American if they self-identify as African American and were born in the United States. Further they must describe both parents as being African American.
Caucasian Women: Individuals will be considered to be Caucasian if they self-identify as Caucasian.
Healthy Volunteers: The potential enrollee must self identify as a normal volunteer and have this confirmed by having at the screening visit a normal complete blood count, glucose, BUN creatinine, liver and thyroid panel.
Age between 18 and 65 years: This age range is chosen because TG levels across the lifespan from early adulthood through to postmenopausal status. Weare using 65 years of age as a conventional upper limit. In addition, 65 years of age has been used as an age category cut-off by National Health and Nutrition Examination Surveys. Our goal is to detect ethnic differences in the pathways that allow vascular disease to develop. Enrolling women between the ages of 18 and 65 years, maximizes our ability to detect differences in mechanism of action that are truly secondary to ethnicity.
Weight less than 136 kg (300 lbs): This weight restriction is necessitated by the limitations of the DXA scanner. The DXA platform cannot accommodate subjects who weigh more than 136 kg.
BMI between 20 and 45 kg/m2: Women in both ethnic groups will be recruited across BMI nonobese and obese categories. Therefore we will enroll approximately equal numbers of women from each ethnic group in both BMI categories BMI between 20 and 30 kg/m(2) and BMI between 30 and 45 kg/m(2).
EXCLUSION CRITERIA:
Refusal to agree to use barrier contraception: The DXA scan and CT scan should not be performed if the participant is pregnant. In addition, TG levels are directly affected by pregnancy. Even though we will perform pregnancy tests within 7 days of each visit, we also require that the subject agree to abstinence or barrier contraception throughout the study.
Medications which affect parameters under investigation: Examples include corticosteroids, oral contraceptives, hypoglycemic (oral or injection), hypolipidemic, antihypertensive and antipsychotic agents. Oral contraceptives, in particular, are exclusion criteria because the estrogen component of oral contraceptives increase TG levels and would therefore obscure the effect of the test meal on TG levels.
Medical Conditions which affect parameters under investigation: Examples include diabetes, thyroid disease, liver disease, pancreatitis, nephrotic syndrome.
Hispanics: The relationship between TG and insulin resistance in Hispanic White women is midway between African American and Caucasian women. Therefore in this initial study to be able to determine the maximum ethnic difference in the relationship between TG and insulin resistance, we will enroll in this protocol study women who self-identify as African American and Caucasian and not enroll women who self-identify as Hispanic.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00484861
Study Brief:
Protocol Section:
NCT00484861