NCT05014997

Brief 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. The aim of this study to investigate the TyG index levels and its relationship with insulin resistance and endothelial dysfunction in patients with KS.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

August 16, 2021

Last Update Submit

August 19, 2021

Conditions

Keywords

Klinefelter Syndrome, TyG Index, Cardiometabolic risk

Outcome Measures

Primary Outcomes (1)

  • Cardiometabolic risk

    Triglyceride - Glucose Index

    1 day

Study Arms (2)

Patient

30 male patients with Klinefelter syndrome who were not previously given testosterone replacement.

Other: no intervention

Control

30 healthy control subject without diagnosis of any chronic disease

Other: no intervention

Interventions

this study was designed as retrospective observational study

ControlPatient

Eligibility Criteria

Age18 Years - 28 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWe had a patient database consisting of male patients with Klinefelter syndrome
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A total of 30 male patients with treatment-naive Klinefelter syndrome and 30 control subjects without any chronic disease

You may qualify if:

  • Patients with a verified Klifelter Syndrome karyotype (all subjects included were 47, XXY) and who were not previously given testosterone replacement.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesKlinefelter Syndrome

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesHypogonadism

Study Officials

  • Alper Sonmez, Prof.

    Health Sciences University, Gulhane School of Medicine, dep. of Endocrinology and Metabolism, Turkey

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 20, 2021

Study Start

February 10, 2013

Primary Completion

October 1, 2014

Study Completion

March 1, 2017

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share