Study of the Steroid Hormone Milieu in Obese Patients

Obesity, Morbid Clinical Trial

— MiSterO  

Official title:

Studio Del Milieu Steroideo in Pazienti Obesi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341699
• Other study ID #: 05C308
• Status: Recruiting
• Start date: May 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Biagio Cangiano, MD
• Phone: 3343177491
• Email: b.cangiano[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Locations

Country	Name	City	State
Italy	Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo	Oggebbio	Verbania

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of androgen milieu with the severity of obesity	Evaluate the association of hypogonadism and/or androgen receptor polymorphisms that reduce sensitivity to androgens with: patients' BMI; comorbidities of obesity, and bone metabolism	2024
Primary	Association of cortisol milieu with the severity of obesity	Evaluate the association of hypercortisolism and/or glucocorticoid receptor polymorphisms that increase sensitivity to cortisol with: patients' BMI; comorbidities of obesity, and bone metabolism	2024
Primary	Algorithm fo CV risk in obesity	Use of artificial intelligence methods to hypothesize an algorithm including steroid milieu that can identify obese patients at greater cardiovascular risk	2024
Secondary	Prevalence of hypogonadism in morbid obesity	To evaluate the prevalence of hypogonadism in patients with severe obesity using EMAS criteria	2024
Secondary	Prevalence of patients with morbid obesity unresponsive to overnight suppression test	To evaluate the prevalence of patients with severe obesity positive to Nugent testing	2024
Secondary	Enrichment in rare HH variants in obese patients with central hypogonadism	Compare the enrichment in rare variants for HH-associated genes in obese patients with hypogonadotropic hypogonadism, compared to the general population	2025
Secondary	Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing	Compare the enrichment in rare variants in genes associated with hypercortisolism in obese patients unresponsive to Nugent testing, compared to the general population	2025