Type 2 Diabetes, Obesity and Cortisol Excess
Diabetes Mellitus, Type 2 · Obesity · Cortisol; Hypersecretion
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - 75 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 3200 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
patients with T2D and Obesity
Exclusion Criteria:
- 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
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
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
T2D
patients with Type2 diabetes (T2D)
Diagnostic Test: 1mg DST
obese without T2D
obese patients without Type 2 diabetes (T2D)
Diagnostic Test: 1mg DST
1mg DST DIAGNOSTIC_TEST
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (5)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
5 locations
Istituto Auxologico ItalianoMilan, ItalyRecruiting
Niguarda HospitalMilan, ItalyRecruiting
Campus Bio-Medico UniversityRoma, ItalyRecruiting
University of SienaSiena, ItalyRecruiting
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di UdineUdine, ItalyRecruiting
Study team and timeline
- Lead sponsor
- Istituto Auxologico Italiano
- Study start
- May 6, 2022 Actual
- Primary completion
- Dec 31, 2026 Estimated
- Study completion
- Dec 31, 2026 Estimated
- First posted
- Mar 8, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Type 2 Diabetes, Obesity and Cortisol Excess
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026