Study of the Steroid Hormone Milieu in Obese Patients

NCT ID: NCT06341699

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2026-06-30

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.

Conditions

Obesity, Morbid

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo

Oggebbio, Verbania, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Biagio Cangiano, MD

Role: CONTACT

b.cangiano@auxologico.it

3343177491

Facility Contacts

Biagio Cangiano, MD

Role: primary

b.cangiano@auxologico.it

3343177491

Massimo Scacchi, Professor

Role: backup

massimo.scacchi@unimi.it

Other Identifiers

05C308

Identifier Type: -

Identifier Source: org_study_id