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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo Coordinator of this site? Confirm its status | Oggebbio | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.