TyG Index Levels in Klinefelter Syndrome

August 19, 2021 updated by: İbrahim Demirci, Gulhane School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 28 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
30 male patients with Klinefelter syndrome who were not previously given testosterone replacement.
Other: no intervention
this study was designed as retrospective observational study
Control
30 healthy control subject without diagnosis of any chronic disease
Other: no intervention
this study was designed as retrospective observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic risk
Time Frame: 1 day
Triglyceride - Glucose Index
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane School of Medicine

Investigators

  • Study Director: Alper Sonmez, Prof., Health Sciences University, Gulhane School of Medicine, dep. of Endocrinology and Metabolism, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

August 16, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMS_21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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