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NCT Number: NCT06341699

Study of the Steroid Hormone Milieu in Obese Patients

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo

Oggebbio, Verbania, 28824, Italy

Location status: Recruiting

Location contact

Biagio Cangiano, MD

CONTACT

[email protected]

3343177491

Massimo Scacchi, Professor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Association of androgen milieu with the severity of obesity

    Time frame: 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

  2. Association of cortisol milieu with the severity of obesity

    Time frame: 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

  3. Algorithm fo CV risk in obesity

    Time frame: 2024

    Use of artificial intelligence methods to hypothesize an algorithm including steroid milieu that can identify obese patients at greater cardiovascular risk

Secondary outcomes

  1. Prevalence of hypogonadism in morbid obesity

    Time frame: 2024

    To evaluate the prevalence of hypogonadism in patients with severe obesity using EMAS criteria

  2. Prevalence of patients with morbid obesity unresponsive to overnight suppression test

    Time frame: 2024

    To evaluate the prevalence of patients with severe obesity positive to Nugent testing

  3. Enrichment in rare HH variants in obese patients with central hypogonadism

    Time frame: 2025

    Compare the enrichment in rare variants for HH-associated genes in obese patients with hypogonadotropic hypogonadism, compared to the general population

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

    Time frame: 2025

    Compare the enrichment in rare variants in genes associated with hypercortisolism in obese patients unresponsive to Nugent testing, compared to the general population

Study contacts

Contact information is provided by the study sponsor or research team.

Biagio Cangiano, MD

CONTACT

[email protected]

3343177491

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • Ministry of Health, Italy

Registry information

Official study title

Studio Del Milieu Steroideo in Pazienti Obesi

Acronym: MiSterO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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