Klinefelter SyndromePhase 4NCT05498090
Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
A Phase 4 study testing Fenofibrate 145 mg in people with Klinefelter Syndrome, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Klinefelter Syndrome
- What is being tested?
- Fenofibrate 145 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 30 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
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
- Being tested
- Fenofibrate 145 mg
- Keywords
- Klinefelters, XXY, 47, XXY, Klinefelter's Syndrome, Klinefelter
- Medical subject headings
- Klinefelter Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate 145 mgDrug
Fenofibrate 145 mg PO daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Cross-sectional, Cases v. Controls) | No intervention | Cases (those with Klinefelter) vs. controls (those without Klinefelter) |
| Arm 2 (Interventional with cases) | Experimental | Cases (those with Klinefelter); Comparison of outcomes pre and post fenofibrate intervention, 145mg PO daily for 4 weeks Receives: Drug: Fenofibrate 145 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal rate of fat oxidation
maximal rate of fat oxidation during prolong submaximal exercise
Measured: 1 month
skeletal muscle fat oxidation
Maximal skeletal muscle mitochondrial respiration with lipid substrate
Measured: 1 month
Secondary outcomes (2)
differentially-expressed genes in plasma
Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from fasting blood draw
Measured: 1 month
differentially-expressed genes in skeletal muscle tissue
Expression levels of UCP2, PLTP, CRAT, ECH1, SLC27A1, SLC27A4, CPT1B from skeletal muscle biopsy
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start3 Nov 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Klinefelter SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms in study: cross-sectional (cases v. controls); interventional (cases only: pre and post fenofibrate intervention)
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanlee M Davis, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498090
- Sponsor's protocol ID
- 21-2860
- Status last verified
- Apr 2024
- First submitted
- 9 Aug 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
- ClinicalTrials.gov ID
- NCT05498090
- Acronym / sponsor ID
- 21-2860
- Conditions
- Klinefelter Syndrome
- Keywords
- Klinefelters, XXY, 47, XXY, Klinefelter's Syndrome, Klinefelter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms in study: cross-sectional (cases v. controls); interventional (cases only: pre and post fenofibrate intervention)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Cross-sectional, Cases v. Controls) | No intervention | –Cases (those with Klinefelter) vs. controls (those without Klinefelter) |
| Arm 2 (Interventional with cases) | Experimental | Drug: Fenofibrate 145 mgCases (those with Klinefelter); Comparison of outcomes pre and post fenofibrate intervention, 145mg PO daily for 4 weeks |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fenofibrate 145 mgFenofibrate 145 mg PO daily for 4 weeks | Drug | Arm 2 (Interventional with cases) |
Primary outcome
maximal rate of fat oxidation
Time frame: 1 month
maximal rate of fat oxidation during prolong submaximal exercise
skeletal muscle fat oxidation
Time frame: 1 month
Maximal skeletal muscle mitochondrial respiration with lipid substrate
2 secondary outcomes
differentially-expressed genes in plasma
Time frame: 1 month
differentially-expressed genes in skeletal muscle tissue
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanlee M Davis, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fenofibrate 145 mg in people with Klinefelter Syndrome, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal rate of fat oxidation (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.