Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3200 participants
OBSERVATIONAL
2022-05-06
2025-12-06
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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T2D
patients with Type2 diabetes (T2D)
1mg DST
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
obese without T2D
obese patients without Type 2 diabetes (T2D)
1mg DST
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
Interventions
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1mg DST
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
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University of Siena
OTHER
Niguarda Hospital
OTHER
Campus Bio-Medico University
OTHER
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
OTHER
Istituto Auxologico Italiano
OTHER
Responsible Party
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Locations
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Istituto Auxologico Italiano
Milan, , Italy
Niguarda Hospital
Milan, , Italy
Campus Bio-Medico University
Roma, , Italy
University of Siena
Siena, , Italy
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine
Udine, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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05J101
Identifier Type: -
Identifier Source: org_study_id
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