Cardiac EventNCT05014997
TyG Index Levels in Klinefelter Syndrome
An observational study of Cardiac Event and Klinefelter Syndrome, run by Gulhane School of Medicine.
Trial summary
It is well known that the frequency of cardiometabolic diseases are increased in patients with Klinefelter Syndrome. The triglyceride-glucose index (TyG index) is a simple surrogate marker of insulin resistance and is also associated with various cardiometabolic diseases. Read more about this study
- Who is it for?
- Ages 18 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiac Event, Klinefelter Syndrome, Endothelial Dysfunction
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2013to 1 Mar 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 28 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: A total of 30 male patients with treatment-naive Klinefelter syndrome and 30 control subjects without any chronic disease
Who may be able to join
- Patients with a verified Klifelter Syndrome karyotype (all subjects included were 47, XXY) and who were not previously given testosterone replacement.
Who cannot join
- age <18 years,
- acute infection, malignancy, any visceral organ dysfunction, nutritional derangements, clinical history of cardiovascular disease, cerebrovascular disease, drug use such as antidiabetic or lipid-lowering medications, or those lacking complete clinical data.
About this study
Official title: Triglyceride-Glucose Index Levels in Patients With Klinefelter Syndrome and Its Relationship With the Endothelial Dysfunction and Insulin Resistance: A Cross-sectional Observational Study
It is well known that the frequency of cardiometabolic diseases are increased in patients with Klinefelter Syndrome. The triglyceride-glucose index (TyG index) is a simple surrogate marker of insulin resistance and is also associated with various cardiometabolic diseases. The aim of this study to investigate the TyG index levels and its relationship with insulin resistance and endothelial dysfunction in patients with KS.
Read the detailed description
From the patient database of our Endocrinology department we randomly included a total of 30 patients with KS and 32 healthy controls in the study. All the recorded data in the database were registered under the approval of Local Ethical Committee of Gulhane School of Medicine.
The clinical and laboratory parameters, TyG index, asymmetric dimethylarginine (ADMA), homeostatic model assessment of insulin resistance (HOMA-IR) and high-sensitivity C-reactive protein (hs-CRP) levels were gathered from the database and the triglyceride-glucose index was calculated by the help of pre-measured laboratory parameters.
- Conditions
- Cardiac Event, Klinefelter Syndrome, Endothelial Dysfunction
- Being tested
- no intervention
- Keywords
- Klinefelter Syndrome, TyG Index, Cardiometabolic risk
- Medical subject headings
- Cardiovascular Diseases, Klinefelter Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
this study was designed as retrospective observational study
| Study group | Role | What they receive |
|---|---|---|
| Patient | 30 male patients with Klinefelter syndrome who were not previously given testosterone replacement. Receives: Other: no intervention | |
| Control | 30 healthy control subject without diagnosis of any chronic disease Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiometabolic risk
Triglyceride - Glucose Index
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start10 Feb 2013
- Primary completion1 Oct 2014
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İbrahim Demirci, Gulhane Training and Research Hospital
- Investigators
- Alper Sonmez, Prof., Study director, Health Sciences University, Gulhane School of Medicine, dep. of Endocrinology and Metabolism, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014997
- Sponsor's protocol ID
- GMS_21
- Status last verified
- Aug 2021
- First submitted
- 16 Aug 2021
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triglyceride-Glucose Index Levels in Patients With Klinefelter Syndrome and Its Relationship With the Endothelial Dysfunction and Insulin Resistance: A Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT05014997
- Acronym / sponsor ID
- GMS_21
- Conditions
- Cardiac Event, Klinefelter Syndrome, Endothelial Dysfunction
- Keywords
- Klinefelter Syndrome, TyG Index, Cardiometabolic risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 10 Feb 2013 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 20 Aug 2021 (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.
It is well known that the frequency of cardiometabolic diseases are increased in patients with Klinefelter Syndrome. The triglyceride-glucose index (TyG index) is a simple surrogate marker of insulin resistance and is also associated with various cardiometabolic diseases. The aim of this study to investigate the TyG index levels and its relationship with insulin resistance and endothelial dysfunction in patients with KS.
Detailed description
From the patient database of our Endocrinology department we randomly included a total of 30 patients with KS and 32 healthy controls in the study. All the recorded data in the database were registered under the approval of Local Ethical Committee of Gulhane School of Medicine.
The clinical and laboratory parameters, TyG index, asymmetric dimethylarginine (ADMA), homeostatic model assessment of insulin resistance (HOMA-IR) and high-sensitivity C-reactive protein (hs-CRP) levels were gathered from the database and the triglyceride-glucose index was calculated by the help of pre-measured laboratory parameters.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: no intervention30 male patients with Klinefelter syndrome who were not previously given testosterone replacement. |
| Control | – | Other: no intervention30 healthy control subject without diagnosis of any chronic disease |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 30 male patients with treatment-naive Klinefelter syndrome and 30 control subjects without any chronic disease
Key inclusion criteria (1 listed)
- Patients with a verified Klifelter Syndrome karyotype (all subjects included were 47, XXY) and who were not previously given testosterone replacement.
Key exclusion criteria (2 listed)
- age <18 years,
- acute infection, malignancy, any visceral organ dysfunction, nutritional derangements, clinical history of cardiovascular disease, cerebrovascular disease, drug use such as antidiabetic or lipid-lowering medications, or those lacking complete clinical data.
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 |
|---|---|---|
| no interventionthis study was designed as retrospective observational study | Other | Control, Patient |
Primary outcome
Cardiometabolic risk
Time frame: 1 day
Triglyceride - Glucose Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Alper Sonmez, Prof. study director
Health Sciences University, Gulhane School of Medicine, dep. of Endocrinology and Metabolism, Turkey
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Event and Klinefelter Syndrome, run by Gulhane School of Medicine.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiometabolic risk (time frame: 1 day). 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 20 Aug 2021.