Type 2 Diabetes, Obesity and Cortisol Excess

Obesity Clinical Trial

— DOCOR  

Official title:

Type 2 Diabetes, Obesity and Cortisol Excess

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759637
• Other study ID #: 05J101
• Status: Recruiting
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cortisol; Hypersecretion
• Cushing Syndrome
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Diagnostic Test:
• 1mg DST
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hidden Hypercortisolism prevalence in a sample of T2D patients	prevalence of patients with F-1mgDST>1.8 mcg/dl	24 months
Primary	Hidden Hypercortisolism prevalence in a sample of Obese patients	prevalence of patients with F-1mgDST>1.8 mcg/dl	24 months