Type 2 Diabetes, Obesity and Cortisol Excess
DOCOR
1 other identifier
observational
3,200
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2022
CompletedFirst Submitted
Initial submission to the registry
February 26, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2025
CompletedMarch 24, 2025
March 1, 2025
3.6 years
February 26, 2023
March 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Hidden Hypercortisolism prevalence in a sample of T2D patients
prevalence of patients with F-1mgDST\>1.8 mcg/dl
24 months
Hidden Hypercortisolism prevalence in a sample of Obese patients
prevalence of patients with F-1mgDST\>1.8 mcg/dl
24 months
Study Arms (2)
T2D
patients with Type2 diabetes (T2D)
obese without T2D
obese patients without Type 2 diabetes (T2D)
Interventions
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
Eligibility Criteria
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
You may qualify if:
- patients with T2D and Obesity
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Auxologico Italianolead
- University of Sienacollaborator
- Niguarda Hospitalcollaborator
- Campus Bio-Medico Universitycollaborator
- Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italycollaborator
Study Sites (5)
Istituto Auxologico Italiano
Milan, 20135, Italy
Niguarda Hospital
Milan, 20162, Italy
Campus Bio-Medico University
Roma, 00128, Italy
University of Siena
Siena, 53100, Italy
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine
Udine, 33100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2023
First Posted
March 8, 2023
Study Start
May 6, 2022
Primary Completion
December 6, 2025
Study Completion
December 6, 2025
Last Updated
March 24, 2025
Record last verified: 2025-03