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NCT06341699Recruiting

Study of the Steroid Hormone Milieu in Obese Patients

Studio Del Milieu Steroideo in Pazienti Obesi

Source: ClinicalTrials.gov · Last updated 13 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
180 (estimated)
First submitted
16 Mar 2024
Start date
16 May 2023
Primary completion date
30 Jun 2026
Lead sponsor
Istituto Auxologico Italiano
Diseases
Obesity
NCT number
NCT06341699

What you commit to

  • Study type: Observational
  • Planned participants: 180
  • From 16 May 2023 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • use of corticosteroids at the time of enrollment

Lab values

  • patients suffering from severe systemic pathologies, fever, chronic inflammatory states known to cause PCR \>10 mg/dL

Other

  • the patient's poor understanding of spoken and written Italian
  • patients suffering from primary pathologies of the testicle, known at enrollment
  • patients suffering from hypothalamic-pituitary or adrenal pathologies already known at the time of enrollment

Who the study is looking for

  • morbid obesity

Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo
Coordinator of this site? Confirm its status
OggebbioItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.