Cardiometabolic Profiles of Boys With Klinefelter Syndrome (NCT02723305) | Clinical Trial Compass
CompletedNot Applicable
Cardiometabolic Profiles of Boys With Klinefelter Syndrome
United States31 participantsStarted 2016-05
Plain-language summary
This study plans to learn more about how to measure the way the the body's energy system works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This is important to know so that investigators understand how hormones and an extra X chromosome relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.
Who can participate
Age range
12 Years – 17 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male, 47,XXY karyotype (non-mosaic)
* Age 12-17 years
* Tanner stage 3-5 pubic hair
* T naïve group only: No exogenous androgen exposure within the past 5 years
* T exposed group only: currently on topical testosterone, with duration of treatment between 1-2 years.
Exclusion Criteria:
* Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
* MRI incompatible metal
* Diagnosis of type 1 or type 2 diabetes
* Hypertension greater than 140/90 mm/Hg at rest (would make exercise studies unsafe)
* Weight \> 300 lbs (limit for DEXA)
* Testosterone treatment for \<1 year or \>2 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.