Study of the Steroid Hormone Milieu in Obese Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Obesity, Morbid. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Studio Del Milieu Steroideo in Pazienti Obesi
Overview
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.
Primary outcome measures
- Association of androgen milieu with the severity of obesity [Time frame: 2024]
- Association of cortisol milieu with the severity of obesity [Time frame: 2024]
- Algorithm fo CV risk in obesity [Time frame: 2024]
Secondary outcome measures (4)
- Prevalence of hypogonadism in morbid obesity [Time frame: 2024]
- Prevalence of patients with morbid obesity unresponsive to overnight suppression test [Time frame: 2024]
- Enrichment in rare HH variants in obese patients with central hypogonadism [Time frame: 2025]
- Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing [Time frame: 2025]
Eligibility criteria
Inclusion criteria
- morbid obesity
Exclusion criteria
- patients suffering from severe systemic pathologies, fever, chronic inflammatory states known to cause PCR >10 mg/dL
- use of corticosteroids at the time of enrollment
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
Italy · 1 center
- Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo — Oggebbio
Identifiers
NCT: NCT06341699 · 05C308