Actively Recruiting
Study of the Steroid Hormone Milieu in Obese Patients
Led by Istituto Auxologico Italiano · Updated on 2025-05-13
180
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
I
Istituto Auxologico Italiano
Lead Sponsor
M
Ministry of Health, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study of the Steroid Hormone Milieu in Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 80 years
- Diagnosis of morbid obesity
You will not qualify if you...
- Severe systemic diseases, fever, or chronic inflammatory conditions with PCR greater than 10 mg/dL
- Current use of corticosteroids
- Poor understanding of spoken and written Italian
- Known primary diseases of the testicle
- Known hypothalamic-pituitary or adrenal gland diseases at enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo
Oggebbio, Verbania, Italy, 28824
Actively Recruiting
Research Team
B
Biagio Cangiano, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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