Clinical trial NCT05759637: Type 2 Diabetes, Obesity and Cortisol Excess
Official title: Type 2 Diabetes, Obesity and Cortisol Excess
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Obesity
Cortisol; Hypersecretion
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: University of Siena
name: Niguarda Hospital
name: Campus Bio-Medico University
name: Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
First posted: 2023-03-08
Enrollment: 3200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hidden Hypercortisolism prevalence in a sample of T2D patients
timeFrame: 24 months
measure: Hidden Hypercortisolism prevalence in a sample of Obese patients
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano
city: Milan
country: Italy
facility: Niguarda Hospital
city: Roma
country: Italy
facility: Campus Bio-Medico University
city: Siena
country: Italy
facility: University of Siena
city: Udine
country: Italy
facility: Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine
Study officials:
References: