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Type 2 Diabetes, Obesity and Cortisol Excess

Type 2 Diabetes, Obesity and Cortisol Excess

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05759637
Acronym
DOCOR
Enrollment
3200
Registered
2023-03-08
Start date
2022-05-06
Completion date
2025-12-06
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cortisol; Hypersecretion, Diabetes Mellitus, Type 2, Obesity

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.

Interventions

DIAGNOSTIC_TEST1mg DST

measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm

Sponsors

University of Siena
CollaboratorOTHER
Niguarda Hospital
CollaboratorOTHER
Campus Bio-Medico University
CollaboratorOTHER
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
CollaboratorOTHER
Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hidden Hypercortisolism prevalence in a sample of T2D patients24 monthsprevalence of patients with F-1mgDST\>1.8 mcg/dl
Hidden Hypercortisolism prevalence in a sample of Obese patients24 monthsprevalence of patients with F-1mgDST\>1.8 mcg/dl

Countries

Italy

Contacts

Primary ContactValentina Morelli, PhD
v.morelli@auxologico.it02619112547

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026