Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341699
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-16
Brief Title:
Study of the Steroid Hormone Milieu in Obese Patients
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Studio Del Milieu Steroideo in Pazienti Obesi
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MiSterO
Brief Summary:
The aim of this observational study is to evaluate the actual secretion of cortisol and testosterone in obese male subjects together with the receptor sensitivity to these hormones in order to understand whether the hormonal milieu deriving from these parameters is associated with alterations in bone metabolism lipoprotein concentration and function andor the severity and complications of obesity
It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients
Eligible subjects are male patients age 18-80 years with severe obesity and no other known causes of hypercortisolism or hypogonadism
Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment patients anamnestic and clinical data relating to disease complications BMI previous blood tests cortisol suppression with dexamethasone 1 mg will be collected and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones bone metabolism lipoprotein function genetics and receptor analysis
It will be also investigated if this hormonal milieu is a predictive factor for cardiovascular disease in obese patients
Eligible subjects are male patients age 18-80 years with severe obesity and no other known causes of hypercortisolism or hypogonadism
Questionnaires for the evaluation of mood and symptoms will be collected upon enrollment patients anamnestic and clinical data relating to disease complications BMI previous blood tests cortisol suppression with dexamethasone 1 mg will be collected and blood sample will be sent to and analyzed at a centralized laboratory for the study of Steroid hormones bone metabolism lipoprotein function genetics and receptor analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None