Type 2 Diabetes, Obesity and Cortisol Excess

Last updated: March 19, 2025
Sponsor: Istituto Auxologico Italiano
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Female Hormonal Deficiencies/abnormalities

Diabetes Prevention

Treatment

1mg DST

Clinical Study ID

NCT05759637
05J101
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

patients with T2D and Obesity

Exclusion

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) axisactivity, -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 ofT2D will be an exclusion criteria

Study Design

Total Participants: 3200
Treatment Group(s): 1
Primary Treatment: 1mg DST
Phase:
Study Start date:
May 06, 2022
Estimated Completion Date:
December 06, 2025

Study 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.

Connect with a study center

  • Istituto Auxologico Italiano

    Milan, 20135
    Italy

    Active - Recruiting

  • Niguarda Hospital

    Milan, 20162
    Italy

    Active - Recruiting

  • Campus Bio-Medico University

    Roma, 00128
    Italy

    Active - Recruiting

  • University of Siena

    Siena, 53100
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine

    Udine, 33100
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.