Study of the Steroid Hormone Milieu in Obese Patients

NCT06341699 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-05-13

No results posted yet for this study

Summary

The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects, together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism, lipoprotein concentration and function, and/or the severity and complications of obesity.

It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients.

Eligible subjects are male patients (age 18-80 years) with severe obesity and no other known causes of hypercortisolism or hypogonadism.

Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment, patient's anamnestic and clinical data relating to disease complications, BMI, previous blood tests, cortisol suppression with dexamethasone 1 mg will be collected, and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones, bone metabolism, lipoprotein function, genetics and receptor analysis.

Conditions

  • Obesity, Morbid

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV
  • Istituto Auxologico Italiano

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06341699 on ClinicalTrials.gov