Study of the Steroid Hormone Milieu in Obese Patients

NCT06341699 | Recruiting

• 1 other identifier: 05C308
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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

Keywords

hypercortisolism; hypogonadism

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Prevalence of hypogonadism in morbid obesity

  2024

• Prevalence of patients with morbid obesity unresponsive to overnight suppression test

  2024

• Enrichment in rare HH variants in obese patients with central hypogonadism

  2025

• Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing

  2025

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected with severe obesity

You may qualify if:

• morbid obesity

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo

Oggebbio, Verbania, 28824, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples for DNA analysis to study polymorphisms of glucocorticoid and androgen receptors, and NGS to look for rare variants in genes associated with hypogonadotropic hypogonadism and hypercortisolism.

MeSH Terms

Conditions

Obesity, Morbid; Cushing Syndrome; Hypogonadism

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Biagio Cangiano, MD

CONTACT

3343177491; b.cangiano@auxologico.it

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: April 2, 2024
• Study Start: May 16, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

IT (1)