Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome

University of Colorado Denver (CU Denver)

Status and phase

Active, not recruiting

Phase 4

Conditions

Klinefelter Syndrome

Treatments

Drug: Fenofibrate 145 mg

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05498090

21-2860

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

Male

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

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