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

NCT ID: NCT05498090

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-03
• Study Completion Date: 2025-08-30

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.

Conditions

Klinefelter Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm 1 (Cross-sectional, Cases v. Controls)

Cases (those with Klinefelter) vs. controls (those without Klinefelter)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2 (Interventional with cases)

Cases (those with Klinefelter); Comparison of outcomes pre and post fenofibrate intervention, 145mg PO daily for 4 weeks

Group Type: EXPERIMENTAL

Fenofibrate 145 mg

Intervention Type: DRUG

Fenofibrate 145 mg PO daily for 4 weeks

Interventions

Fenofibrate 145 mg

Fenofibrate 145 mg PO daily for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shanlee M Davis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Countries

United States

Other Identifiers

21-2860

Identifier Type: -

Identifier Source: org_study_id