Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05759637 |
| Other study ID # |
05J101 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 6, 2022 |
| Est. completion date |
May 6, 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Istituto Auxologico Italiano |
| Contact |
Valentina Morelli, PhD |
| Phone |
02619112547 |
| Email |
v.morelli[@]auxologico.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
