Obesity, MorbidMiSterONCT06341699
Study of the Steroid Hormone Milieu in Obese Patients
An observational study of Obesity, Morbid, run by Istituto Auxologico Italiano at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Obesity, Morbid
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected with severe obesity
Who may be able to join
- morbid obesity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxlogico Italiano, Hospital San Giuseppe, Piancavallo
Oggebbio, Verbania, 28824
Biagio Cangiano, MD, 3343177491, b.cangiano@auxologico.it
Massimo Scacchi, Professor, massimo.scacchi@unimi.it
About this study
Official title: Studio Del Milieu Steroideo in Pazienti Obesi
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.
Read more
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
- Medical subject headings
- Obesity, Morbid, Cushing Syndrome, Hypogonadism
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2024
Secondary outcomes (4)
Prevalence of hypogonadism in morbid obesity
To evaluate the prevalence of hypogonadism in patients with severe obesity using EMAS criteria
Measured: 2024
Prevalence of patients with morbid obesity unresponsive to overnight suppression test
To evaluate the prevalence of patients with severe obesity positive to Nugent testing
Measured: 2024
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
Measured: 2025
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
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start16 May 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341699
- Sponsor's protocol ID
- 05C308
- Acronym
- MiSterO
- Status last verified
- May 2025
- First submitted
- 16 Mar 2024
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Del Milieu Steroideo in Pazienti Obesi
- ClinicalTrials.gov ID
- NCT06341699
- Acronym / sponsor ID
- MiSterO / 05C308
- Conditions
- Obesity, Morbid
- Keywords
- hypercortisolism, hypogonadism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 16 May 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected with severe obesity
Key inclusion criteria (1 listed)
- morbid obesity
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
4 secondary outcomes
Prevalence of hypogonadism in morbid obesity
Time frame: 2024
Prevalence of patients with morbid obesity unresponsive to overnight suppression test
Time frame: 2024
Enrichment in rare HH variants in obese patients with central hypogonadism
Time frame: 2025
Enrichment in rare variants associated with hypercortisolism in obese patients unresponsive to Nugent testing
Time frame: 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biagio Cangiano, MD (3343177491, b.cangiano@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of androgen milieu with the severity of obesity (time frame: 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.