COMPLETED

Brain Blood Flow Responses to Stress: Sex Differences

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Cerebrovascular Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Twenty-six otherwise healthy adults between 18-40 years of age composed of 13 males and 13 females will be enrolled in this study to determine how sex and sex hormones influence cerebral blood flow (CBF) control in healthy young adults without confounds of age or disease. Participants can expect to be on study for approximately 16 days.

Official Title

Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences (Phase 2)

Quick Facts

Study Start:2024-07-24
Study Completion:2025-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06253702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age between ≥18 - ≤40 years inclusive
  2. * Completed Phase 1: Study 2020-0336
  1. * Hypertensive
  2. * \> 125 mmHg systolic blood pressure; or
  3. * \> 80 mmHg diastolic blood pressure
  4. * BMI ≥25 kg/m2
  5. * Fasting blood glucose ≥100 mg/dl
  6. * LDL cholesterol ≥130 mg/dl
  7. * Triglycerides ≥150 mg/dl
  8. * Current diagnosis or history of:
  9. * peripheral vascular disease
  10. * hepatic disease
  11. * renal disease
  12. * lung disease
  13. * gastrointestinal disorders/bleeding
  14. * hematologic disease
  15. * stroke
  16. * myocardial infarction
  17. * coronary heart disease
  18. * congestive heart failure
  19. * heart surgery
  20. * prediabetes
  21. * diabetes mellitus (type 1, type 2, MODY, or others)
  22. * sleep apnea
  23. * hypertension
  24. * some autoimmune diseases, such as inflammatory bowel disease or systemic lupus erythematosus (exclusion at discretion of reviewing MD)
  25. * Current smoking, defined as the use of tobacco or nicotine products \>5 times in the past 30 days.
  26. * Cardiovascular medication use
  27. * NSAID sensitivity
  28. * Magnesium-restricted diet
  29. * Any contraindications of having an MRI
  30. * (e.g. the requirement of anxiolytics in order to complete an MRI scan)
  31. * Irregular menstrual cycle (females only)
  32. * Medical conditions that can affect the menstrual cycle, such as hyperprolactinemia, prolactinoma, hypercortisolemia, and congenital adrenal hyperplasia (females only)
  33. * Pregnancy, breast feeding, or plans to conceive within the next 3 months (females only)
  34. * Polycystic ovary syndrome (females only)
  35. * Hirsutism defined as unwanted and/or excessive hair growth on the face, chest, or back (females only)
  36. * Levonorgestrel intrauterine device (IUD) (females only)
  37. * 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:
  38. * Copper intrauterine devices (IUDs) will be allowed as they do not change systemic sex hormone levels).
  39. * 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.

Contacts and Locations

Principal Investigator

William G Schrage, PhD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • William G Schrage, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-24
Study Completion Date2025-05-31

Study Record Updates

Study Start Date2024-07-24
Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

  • Cerebrovascular Disorders