Study of the Steroid Hormone Milieu in Obese Patients

Recruiting

• Conditions: Obesity, Morbid

• Registration Number: NCT06341699
• Lead Sponsor: Istituto Auxologico Italiano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-16
• Status Verified: 2024-03
• Study First Submitted: 2024-03-16
• Study First Submitted QC: 2024-03-25
• Last Update Submitted: 2024-03-25
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

• morbid obesity

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Algorithm fo CV risk in obesity	2024	Use of artificial intelligence methods to hypothesize an algorithm including steroid milieu that can identify obese patients at greater cardiovascular risk
Association of androgen milieu with the severity of obesity	2024	Evaluate the association of hypogonadism and/or androgen receptor polymorphisms that reduce sensitivity to androgens with: patients' BMI; comorbidities of obesity, and bone metabolism
Association of cortisol milieu with the severity of obesity	2024	Evaluate the association of hypercortisolism and/or glucocorticoid receptor polymorphisms that increase sensitivity to cortisol with: patients' BMI; comorbidities of obesity, and bone metabolism

Secondary Outcome Measures

Name	Time	Method
Enrichment in rare HH variants in obese patients with central hypogonadism	2025	Compare the enrichment in rare variants for HH-associated genes in obese patients with hypogonadotropic hypogonadism, compared to the general population
Prevalence of patients with morbid obesity unresponsive to overnight suppression test	2024	To evaluate the prevalence of patients with severe obesity positive to Nugent testing
Prevalence of hypogonadism in morbid obesity	2024	To evaluate the prevalence of hypogonadism in patients with severe obesity using EMAS criteria
Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing	2025	Compare the enrichment in rare variants in genes associated with hypercortisolism in obese patients unresponsive to Nugent testing, compared to the general population

Trial Locations

Locations (1)

Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo; 🇮🇹 Oggebbio, Verbania, Italy