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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT05958303
Eligibility Criteria:
Inclusion Criteria:
* Age between ≥18 - ≤40 years
Exclusion Criteria:
* Hypertensive
* \>125 mmHg systolic blood pressure; or
* \>80 mmHg diastolic blood pressure
* BMI ≥25 kg/m2
* Fasting blood glucose ≥100 mg/dl
* LDL cholesterol ≥130 mg/dl
* Triglycerides ≥150 mg/dl
* Current diagnosis or history of:
* peripheral vascular disease
* hepatic disease
* renal disease
* lung disease
* gastrointestinal disorders/bleeding
* hematologic disease
* stroke
* myocardial infarction
* coronary heart disease
* congestive heart failure
* heart surgery
* prediabetes
* diabetes mellitus (type 1, type 2, MODY, or others)
* sleep apnea
* hypertension
* some autoimmune diseases, such as inflammatory bowel disease or systemic lupus erythematosus (exclusion at discretion of reviewing MD)
* Current smoking, defined as the use of tobacco or nicotine products \>5 times in the past 30 days.
* Cardiovascular medication use
* NSAID sensitivity
* Any contraindications of having an MRI
o (e.g. the requirement of anxiolytics in order to complete an MRI scan)
* Irregular menstrual cycle (females only)
* Medical conditions that can affect the menstrual cycle, such as hyperprolactinemia, prolactinoma, hypercortisolemia, and congenital adrenal hyperplasia (females only)
* Pregnancy, breast feeding, or plans to conceive within the next 3 months (females only)
* Polycystic ovary syndrome (females only)
* Hirsutism defined as unwanted and/or excessive hair growth on the face, chest, or back (females only)
* Levonorgestrel intrauterine device (IUD) (females only)
* Hormonal birth control will not be allowed in women, in order to control for high variability between type, dose, and route of therapy. However, in discussion with Dr. Davis (Co-I) and Dr. Laura Cooney M.D., physician experts in medical and reproductive endocrinology and infertility, there are two broad exceptions to this birth control criteria:
1. Copper intrauterine devices (IUDs) will be allowed as they do not change systemic sex hormone levels).
2. Women currently taking hormonal birth control (i.e. contraceptive pills, patch, ring) for contraception only (not for a medical condition such as those listed in exclusion criteria above) may consider temporarily stopping to become eligible for enrollment. Hormonal birth control must be stopped at least one month prior to Study Visit 1 to provide time for menstruation to resume. Then stoppage continues through the last planned study visit. Screening information will be reviewed by endocrinology physicians to determine eligibility and timing on this issue (details below).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05958303
Study Brief:
Protocol Section:
NCT05958303