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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05014997
Other study ID # GMS_21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 10, 2013
Est. completion date March 1, 2017

Study information

Verified date August 2021
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 1, 2017
Est. primary completion date October 1, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 28 Years
Eligibility 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 Design


Intervention

Other:
no intervention
this study was designed as retrospective observational study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gulhane School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiometabolic risk Triglyceride - Glucose Index 1 day
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