Type 2 Diabetes, Obesity and Cortisol Excess (DOCOR)

March 9, 2023 updated by: Istituto Auxologico Italiano
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

3200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20135
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T2D
patients with Type2 diabetes (T2D)
Diagnostic test: 1mg DST
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm
obese without T2D
obese patients without Type 2 diabetes (T2D)
Diagnostic test: 1mg DST
measurement of cortisol levels after 1 mg of dexamethasone (DST) at 11 pm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hidden Hypercortisolism prevalence in a sample of T2D patients
Time Frame: 24 months
prevalence of patients with F-1mgDST>1.8 mcg/dl
24 months
Hidden Hypercortisolism prevalence in a sample of Obese patients
Time Frame: 24 months
prevalence of patients with F-1mgDST>1.8 mcg/dl
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2022

Primary Completion (Anticipated)

May 6, 2024

Study Completion (Anticipated)

May 6, 2024

Study Registration Dates

First Submitted

February 26, 2023

First Submitted That Met QC Criteria

February 26, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05J101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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