NCT06341699 Study of the Steroid Hormone Milieu in Obese Patients
| NCT ID | NCT06341699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Auxologico Italiano |
| Condition | Obesity, Morbid |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-05-16 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2023-05-16 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06341699 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06341699 currently recruiting?
Yes, NCT06341699 is actively recruiting participants. Contact the research team at b.cangiano@auxologico.it for enrollment information.
Where is the NCT06341699 trial being conducted?
This trial is being conducted at Oggebbio, Italy.
Who is sponsoring the NCT06341699 clinical trial?
NCT06341699 is sponsored by Istituto Auxologico Italiano. The trial plans to enroll 180 participants.
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