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

Klinefelter Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498090
• Other study ID #: 21-2860
• Status: Recruiting
• Phase: Phase 4
• Start date: November 3, 2022
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Julia Byers, BA
• Phone: 3035201627
• Email: julia.byers[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: August 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Klinefelter Syndrome
• Syndrome

Intervention

Drug:
• Fenofibrate 145 mg
Fenofibrate 145 mg PO daily for 4 weeks

Locations

Country	Name	City	State
United States	University of Colorado - Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal rate of fat oxidation	maximal rate of fat oxidation during prolong submaximal exercise	1 month
Primary	skeletal muscle fat oxidation	Maximal skeletal muscle mitochondrial respiration with lipid substrate	1 month
Secondary	differentially-expressed genes in plasma	Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from fasting blood draw	1 month
Secondary	differentially-expressed genes in skeletal muscle tissue	Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from skeletal muscle biopsy	1 month