Type 2 Diabetes, Obesity and Cortisol Excess
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIstituto Auxologico Italiano
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
pregnancy/breast feeding,
sleep apnea,
prepuberal onset of hypertension, hormonal hypersecreting adrenal mass,
symptoms of hypercortisolism;
Trial 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
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
1mg DST
Diagnostic testmeasurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
Treatment groups
3,200 Participants
are divided into 2 treatment groupsGroup A: T2D1 intervention
Group B: obese without T2D1 intervention
Trial outcomes
Primary outcomes
1
Hidden Hypercortisolism prevalence in a sample of T2D patients
prevalence of patients with F-1mgDST\>1.8 mcg/dl
Time frame
24 months2
Hidden Hypercortisolism prevalence in a sample of Obese patients
prevalence of patients with F-1mgDST\>1.8 mcg/dl
Time frame
24 monthsSponsors and contacts
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Istituto Auxologico Italiano
Lead sponsor
University of Siena
Collaborator
Niguarda Hospital
Collaborator
Campus Bio-Medico University
Collaborator
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
Collaborator
Source ClinicalTrials.gov