Assessing hidden cortisol excess in type 2 diabetes and obesity
Type 2 Diabetes, Obesity and Cortisol Excess
Istituto Auxologico Italiano · NCT05759637
This study is trying to see how common hidden high cortisol levels are in people with type 2 diabetes and in obese individuals without diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano (other) |
| Locations | 5 sites (Milan and 4 other locations) |
| Trial ID | NCT05759637 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence of hidden hypercortisolism (HidHyCo) in patients with type 2 diabetes (T2D) and in obese individuals without T2D. It will analyze the clinical characteristics associated with HidHyCo in both groups. Participants aged 18 to 75 years will be recruited from outpatient clinics specializing in diabetes and obesity. The study will involve a 1mg dexamethasone suppression test (DST) to assess cortisol levels.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with type 2 diabetes or obesity without type 2 diabetes.
Not a fit: Patients with conditions such as pregnancy, sleep apnea, or known secondary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better identification and management of hidden hypercortisolism in patients with type 2 diabetes and obesity, potentially reducing associated complications.
How similar studies have performed: While the prevalence of hidden hypercortisolism has been noted in various populations, this specific approach to assessing it in T2D and obesity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: patients with T2D and Obesity Exclusion Criteria: * 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) * drugs influencing the HPA axis activity. For inclusion in Group 2 the presence of T2D will be an exclusion criteria
Where this trial is running
Milan and 4 other locations
- Istituto Auxologico Italiano — Milan, Italy (RECRUITING)
- Niguarda Hospital — Milan, Italy (RECRUITING)
- Campus Bio-Medico University — Roma, Italy (RECRUITING)
- University of Siena — Siena, Italy (RECRUITING)
- Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine — Udine, Italy (RECRUITING)
Study contacts
- Study coordinator: Valentina Morelli, PhD
- Email: v.morelli@auxologico.it
- Phone: 02619112547
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Obesity, Cortisol, Hypersecretion