Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter … (NCT05498090) | Clinical Trial Compass
UnknownPhase 4
Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
United States44 participantsStarted 2022-11-03
Plain-language summary
This study will learn more about how the body uses energy. Usually, the body uses sugars as energy first and then fats are used when the sugar stores are gone. Some people have trouble using fats as energy. This can lead to feeling tired, difficulty exercising, and storing too much fat where it does not belong (like in the muscle). It is believed that some boys and men with Klinefelter Syndrome may not be able to use fats as energy normally, and that a medication called fenofibrate could help this.
Who can participate
Age range
15 Years – 40 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
* Ages 15 to 40 years
* Total testosterone concentration within the normal range for age and pubertal stage
* For the KS group only: genetic testing results confirming KS
Exclusion Criteria:
* Liver disease (ALT or AST \> 3x upper limit of normal)
* Renal impairment (estimated creatinine clearance \<80 ml/min)
* Diabetes mellitus (A1c \> 6.4%)
* Untreated hypogonadism
* Treatment with a PPAR agonist (including fish oil) or statin within the past month
* Unstable medications with any medication added or removed within the past 2 weeks or plan for medication changes during the study period
* Inability to tolerate study procedures, including any medical conditions that make exercise unsafe at the discretion of the study physician
* For the KS group only: known allergy to fibrates, inability to swallow tablets
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.