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

Primary Purpose

Klinefelter Syndrome

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate 145 mg
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Klinefelter Syndrome focused on measuring Klinefelters, XXY, 47, XXY, Klinefelter's Syndrome, Klinefelter

Eligibility Criteria

15 Years - 40 Years (Child, Adult)MaleAccepts 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

Sites / Locations

  • University of Colorado - Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

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

Arm 2 (Interventional with cases)

Arm Description

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

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

Outcomes

Primary Outcome Measures

maximal rate of fat oxidation
maximal rate of fat oxidation during prolong submaximal exercise
skeletal muscle fat oxidation
Maximal skeletal muscle mitochondrial respiration with lipid substrate

Secondary Outcome Measures

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

Full Information

First Posted
August 9, 2022
Last Updated
February 1, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05498090
Brief Title
Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males With Klinefelter Syndrome
Official Title
Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males With Klinefelter Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Klinefelter Syndrome
Keywords
Klinefelters, XXY, 47, XXY, Klinefelter's Syndrome, Klinefelter

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 arms in study: cross-sectional (cases v. controls); interventional (cases only: pre and post fenofibrate intervention)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (Cross-sectional, Cases v. Controls)
Arm Type
No Intervention
Arm Description
Cases (those with Klinefelter) vs. controls (those without Klinefelter)
Arm Title
Arm 2 (Interventional with cases)
Arm Type
Experimental
Arm Description
Cases (those with Klinefelter); Comparison of outcomes pre and post fenofibrate intervention, 145mg PO daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Fenofibrate 145 mg
Intervention Description
Fenofibrate 145 mg PO daily for 4 weeks
Primary Outcome Measure Information:
Title
maximal rate of fat oxidation
Description
maximal rate of fat oxidation during prolong submaximal exercise
Time Frame
1 month
Title
skeletal muscle fat oxidation
Description
Maximal skeletal muscle mitochondrial respiration with lipid substrate
Time Frame
1 month
Secondary Outcome Measure Information:
Title
differentially-expressed genes in plasma
Description
Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from fasting blood draw
Time Frame
1 month
Title
differentially-expressed genes in skeletal muscle tissue
Description
Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from skeletal muscle biopsy
Time Frame
1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariah Brown, BA
Phone
7207776774
Email
mariah.brown2@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanlee M Davis, MD, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariah Brown, BA
Phone
720-777-6774
Email
mariah.brown2@childrenscolorado.org
First Name & Middle Initial & Last Name & Degree
Shanlee M Davis, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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