Diabetes Mellitus, Type 2DOCORNCT05759637
Type 2 Diabetes, Obesity and Cortisol Excess
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Istituto Auxologico Italiano at 5 sites in Italy.
Trial summary
The present observational cross-sectional study is aimed to assess: the hidden hypercortisolism (HidHyCo) prevalence in a sample of Type 2 diabetes (T2D) patients and the clinical characteristics more frequently associated with the HidHyCo presence and the HidHyCo prevalence in an adequate sample of obese patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Cortisol; Hypersecretion
- What is being tested?
- 1mg DST
- How many people
- 3,200 participants
- Where
- 5 sitesItaly
- Study dates
- 6 May 2022to 6 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All T2D and obese patients between 18 and 75 years of age, consecutively referred to the out-patient clinics for Diabetes and Obesity of our center
Who may be able to join
- patients with T2D and Obesity
Who cannot join
- pregnancy/breast feeding,
- sleep apnea,
- prepuberal onset of hypertension, hormonal hypersecreting adrenal mass,
- symptoms of hypercortisolism;
- already known secondary hypertension;
- conditions associated with increased hypothalamic-pituitary-adrenal (HPA) axis activity, -severe autoimmune/rheumatologic and hematologic diseases, alcoholism, kidney disease (glomerular filtration rate <60)
- drugs influencing the HPA axis activity. For inclusion in Group 2 the presence of T2D will be an exclusion criteria
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Istituto Auxologico Italiano
Milan, 20135
Valentina Morelli, 02619112547, v.morelli@auxologico.it
- Recruiting
Niguarda Hospital
Milan, 20162
Iacopo Chiodini, Prof, +39026444.3376, iacopo.chiodini@ospedaleniguarda.it
- Recruiting
Campus Bio-Medico University
Roma, 00128
Nicola Napoli, Prof, (+39) 06. 22541 697, n.napoli@policlinicocampus.it
- Recruiting
University of Siena
Siena, 53100
Luigi Gennari, Prof, +39 0577585364, gennari@unisi.it
- Recruiting
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine
Udine, 33100
Fabio Vescini, Prof, (+39) 0432 552540, endocrinologia@asufc.sanita.fvg.it
About this study
The present observational cross-sectional study is aimed to assess: the hidden hypercortisolism (HidHyCo) prevalence in a sample of Type 2 diabetes (T2D) patients and the clinical characteristics more frequently associated with the HidHyCo presence and the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.
Read the detailed description
Mild and asymptomatic hypercortisolism has been described to be associated with increased prevalence of chronic complications of cortisol excess, such as osteoporosis, hypertension, type 2 diabetes (T2D) and obesity and with increased mortality. In patients with osteoporosis, hypertension, T2D or obesity, this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo), until its presence is suspected on the basis of particular characteristics of the underlying diseases. The HidHyCo prevalence in the general population is estimated to be 0.2-2%, but it has been suggested to be even higher (up to 10%) in some specific populations as for example in patients T2D. Data regarding the prevalence of HidHyCo in obese populations are limited, Therefore, the issue of which diabetic or obese patient has to be screened for HidHyCo has recently become a widely debated topic. Therefore, the aims of the present study protocol are to assess: i) the HidHyCo prevalence in a sample of T2D patients and the clinical characteristics more frequently associated with the HidHyCo presence; ii) the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.
All T2D and obese-without T2D patients between 18 and 75 years of age, consecutively referred to the out-patient clinics for Diabetes and Obesity of our center will be assessed for possible inclusion. At the enrolment in all patients anthropometric e biochemical variables will be recorded. At the enrolment we will evaluate cortisol levels after dexamethasone suppression test (F-1mgDST) in all T2D and obese-without T2D patients, who have been included in the study and who have given the informed consent to participate in the study. In all subjects with F-1mgDST >1.8 μg/dL, cortisol levels after two-day low dose (2 mg/day) dexamethasone suppression test (F-2mgx2dDST) will be performed. Patients with F-2mgx2dDST above >1.8 μg/dL will be considered affected with possible HidHyCo and will be studied following the available guidelines for the diagnosis of hypercortisolism.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Cortisol; Hypersecretion
- Being tested
- 1mg DST
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1mg DSTDiagnostic test
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
| Study group | Role | What they receive |
|---|---|---|
| T2D | patients with Type2 diabetes (T2D) Receives: Diagnostic Test: 1mg DST | |
| obese without T2D | obese patients without Type 2 diabetes (T2D) Receives: Diagnostic Test: 1mg DST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hidden Hypercortisolism prevalence in a sample of T2D patients
prevalence of patients with F-1mgDST>1.8 mcg/dl
Measured: 24 months
Hidden Hypercortisolism prevalence in a sample of Obese patients
prevalence of patients with F-1mgDST>1.8 mcg/dl
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start6 May 2022
- Primary completion6 Dec 2025 (estimated)
- Study completion6 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- University of Siena, Niguarda Hospital, Campus Bio-Medico University, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759637
- Sponsor's protocol ID
- 05J101
- Acronym
- DOCOR
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2023
- Last updated
- 24 Mar 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes, Obesity and Cortisol Excess
- ClinicalTrials.gov ID
- NCT05759637
- Acronym / sponsor ID
- DOCOR / 05J101
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Cortisol; Hypersecretion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- University of Siena, Niguarda Hospital, Campus Bio-Medico University, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
- Study start
- 6 May 2022 (actual)
- Primary completion
- 6 Dec 2025 (estimated)
- Study completion
- 6 Dec 2025 (estimated)
- First posted
- 8 Mar 2023 (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 present observational cross-sectional study is aimed to assess: the hidden hypercortisolism (HidHyCo) prevalence in a sample of Type 2 diabetes (T2D) patients and the clinical characteristics more frequently associated with the HidHyCo presence and the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.
Detailed description
Mild and asymptomatic hypercortisolism has been described to be associated with increased prevalence of chronic complications of cortisol excess, such as osteoporosis, hypertension, type 2 diabetes (T2D) and obesity and with increased mortality. In patients with osteoporosis, hypertension, T2D or obesity, this form of hypercortisolism may remain occult (hidden hypercortisolism, HidHyCo), until its presence is suspected on the basis of particular characteristics of the underlying diseases. The HidHyCo prevalence in the general population is estimated to be 0.2-2%, but it has been suggested to be even higher (up to 10%) in some specific populations as for example in patients T2D. Data regarding the prevalence of HidHyCo in obese populations are limited, Therefore, the issue of which diabetic or obese patient has to be screened for HidHyCo has recently become a widely debated topic. Therefore, the aims of the present study protocol are to assess: i) the HidHyCo prevalence in a sample of T2D patients and the clinical characteristics more frequently associated with the HidHyCo presence; ii) the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.
All T2D and obese-without T2D patients between 18 and 75 years of age, consecutively referred to the out-patient clinics for Diabetes and Obesity of our center will be assessed for possible inclusion. At the enrolment in all patients anthropometric e biochemical variables will be recorded. At the enrolment we will evaluate cortisol levels after dexamethasone suppression test (F-1mgDST) in all T2D and obese-without T2D patients, who have been included in the study and who have given the informed consent to participate in the study. In all subjects with F-1mgDST >1.8 μg/dL, cortisol levels after two-day low dose (2 mg/day) dexamethasone suppression test (F-2mgx2dDST) will be performed. Patients with F-2mgx2dDST above >1.8 μg/dL will be considered affected with possible HidHyCo and will be studied following the available guidelines for the diagnosis of hypercortisolism.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2D | – | Diagnostic Test: 1mg DSTpatients with Type2 diabetes (T2D) |
| obese without T2D | – | Diagnostic Test: 1mg DSTobese patients without Type 2 diabetes (T2D) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All T2D and obese patients between 18 and 75 years of age, consecutively referred to the out-patient clinics for Diabetes and Obesity of our center
Key inclusion criteria (1 listed)
- patients with T2D and Obesity
Key exclusion criteria (7 listed)
- pregnancy/breast feeding,
- sleep apnea,
- prepuberal onset of hypertension, hormonal hypersecreting adrenal mass,
- symptoms of hypercortisolism;
- already known secondary hypertension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1mg DSTmeasurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm | Diagnostic test | T2D, obese without T2D |
Primary outcome
Hidden Hypercortisolism prevalence in a sample of T2D patients
Time frame: 24 months
prevalence of patients with F-1mgDST>1.8 mcg/dl
Hidden Hypercortisolism prevalence in a sample of Obese patients
Time frame: 24 months
prevalence of patients with F-1mgDST>1.8 mcg/dl
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 24 Mar 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Obesity, run by Istituto Auxologico Italiano at 5 sites 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 7 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Valentina Morelli, PhD (02619112547, v.morelli@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hidden Hypercortisolism prevalence in a sample of T2D patients (time frame: 24 months). The study lists 2 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 24 Mar 2025.