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

Phase 4

Active, not recruiting

• Conditions: Klinefelter Syndrome
• Interventions: Drug: Fenofibrate 145 mg

• Registration Number: NCT05498090
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-11-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 (Interventional with cases)	Fenofibrate 145 mg	Cases (those with Klinefelter); Comparison of outcomes pre and post fenofibrate intervention, 145mg PO daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
maximal rate of fat oxidation	1 month	maximal rate of fat oxidation during prolong submaximal exercise
skeletal muscle fat oxidation	1 month	Maximal skeletal muscle mitochondrial respiration with lipid substrate

Secondary Outcome Measures

Name	Time	Method
differentially-expressed genes in plasma	1 month	Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from fasting blood draw
differentially-expressed genes in skeletal muscle tissue	1 month	Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from skeletal muscle biopsy

Trial Locations

Locations (1)

University of Colorado - Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States