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

Phase 4Active Not RecruitingNCT05498090

University of Colorado, Denver44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Klinefelter Syndrome

Interventions

Fenofibrate 145 mgDRUG

Fenofibrate 145 mg PO daily for 4 weeks

Eligibility

Sex: MALEMin age: 15 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

maximal rate of fat oxidation

maximal rate of fat oxidation during prolong submaximal exercise

Time frame: 1 month

skeletal muscle fat oxidation

Maximal skeletal muscle mitochondrial respiration with lipid substrate

Time frame: 1 month

Secondary Outcomes

differentially-expressed genes in plasma

Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from fasting blood draw

Time frame: 1 month

differentially-expressed genes in skeletal muscle tissue

Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from skeletal muscle biopsy

Time frame: 1 month

Data from ClinicalTrials.gov

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