Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism (CUSHINGOMICS) (CUSHINGOMICS)

May 18, 2026 updated by: Assistance Publique - Hôpitaux de Paris

Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism

The excess of glucocorticoid, whether endogenous or exogenous, results in Cushing's syndrome, associating a particular distribution of fats (accumulation in the face and trunk), a decrease in the thickness of the muscles, diabetes, hypertension or osteoporosis.

The level of effects obviously depends on the extent of the excess glucocorticoids, and on the duration of this exposure. However, the manifestations of Cushing's syndrome also depend very much on the sensitivity of each individual to glucocorticoids for each of these conditions. Indeed, for the same duration and level of exposure, some will have diabetes only, others only osteoporosis, others hypertension, while still others will have these three complications. Today the investigators are unable to specify individual risks. For example, will someone develop diabetes when exposed to glucocorticoids? Or on the contrary will blood sugar level remain normal? The same question arises for hypertension and osteoporosis.

The deficiency of glucocorticoid, called adrenal insufficiency, causes fatigue and discomfort. The intensity of the signs depends on the depth of the insufficiency. Here again, there is a large variability in the sensitivity of each individual to glucocorticoids: when one substitutes for adrenal insufficiency at a given dose, some individuals will feel well, while others will still remain tired. The investigators are unable to specify participant's individual requirement.

The aim of this research is to identify factors that determine individual sensitivity to glucocorticoids. For excess glucocorticoids, the investigators are looking for specific molecular markers for each type of glucocorticoid complication: markers for corticosteroid-induced diabetes, corticosteroid-induced hypertension, or corticosteroid-induced osteoporosis.

For adrenal insufficiency, they are also looking for substitute good balance markers for adrenal insufficiency.

To answer the research question, it is planned to include 400 subjects exposed to glucocorticoid excess (by excess of endogenous glucocorticoids or induced by corticosteroid therapy) and 100 subjects with adrenal insufficiency. It is also planned to include 100 subjects without excess glucocorticoids but presenting either diabetes, hypertension or osteoporosis; these subjects will constitute a control group. The investigators will perform a very large number of measurements in small amounts of blood and urine, in order to identify a few marks specifically associated with each of the complications. This research will identify, for every person exposed to glucocorticoids, the probability of developping some complications, and reversely the probability of being exempt from other complications.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For each participant, easily accessible biological samples will be taken (blood, urine, saliva). From these samples, a large number of molecular markers will be generated (genomics, metabolomics), in search of signatures specifically associated with each complication.

Three main types of complications will be analyzed: diabetes, hypertension and osteoporosis.

The analysis is planned in 4 stages:

  • Identify markers for each type of complication in the context of excess frank glucocorticoids, by comparing affected patients and those not affected for each type of complication.
  • Subtraction of non-specific markers of diabetes, hypertension and osteoporosis, identified by the analysis of diabetic, hypertensive and osteoporotic patients who do not have excess glucocorticoids
  • Test the performance of these markers in an independent cohort of patients presenting an excess of glucocorticoids at variable levels: frank and at least (endogenous, exogenous)
  • Test the performance of these markers in a cohort of patients with substituted adrenal insufficiency

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Cochin

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • an endogenous hypercortisolism (group 1)
  • a disease justifying the next start of glucocorticoid therapy (group 2)
  • chronic adrenal insufficiency (group 3)
  • subjects with either diabetes, hypertension or osteoporosis, but without glucocorticoid excess (control group)
  • patients will have to be affiliated to a social security scheme
  • patients should be able to understand the study and able to express their consent

Exclusion Criteria:

  • patients with reduced life expectancy, less than 2 years
  • pregnant or lactating women
  • patients refusing the protocol
  • patients under state medical assistance

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Excess of endogenous glucoglucocorticoids (group 1)
v
Biological: Biological samples
blood, urine, saliva
Other: Complications
bone mineral density, diabetes, hypertension, quality of life (quality of life questionnaire SF-36)
Experimental: Exogenous hypercortisolisms (group 2)
a disease justifying the up-coming start of a glucocorticoid therapy
Biological: Biological samples
blood, urine, saliva
Other: Complications
bone mineral density, diabetes, hypertension, quality of life (quality of life questionnaire SF-36)
Experimental: Adrenal insufficiency (group 3)
chronic adrenal insufficiency
Biological: Biological samples
blood, urine, saliva
Other: Complications
bone mineral density, diabetes, hypertension, quality of life (quality of life questionnaire SF-36)
Other: Control (group 4)
without glucocorticoid excess
Biological: Biological samples
blood, urine, saliva
Other: Complications
bone mineral density, diabetes, hypertension, quality of life (quality of life questionnaire SF-36)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identification of molecular markers of glucocorticoid-induced hypertension (diagnosed by oscillometric blood pressure), using genomic and metabolomics measurements
Time Frame: 3 years
Genomic measurements will include whole blood methylome, transcriptome and miRNome. Metabolomic measurements will be performed by mass spectrometry in blood plasma and urine, to characterize a large panel of biochemical compounds. Relevant markers identified with these high throughput methods will be combined into a single multidimensional composite predictor.
3 years
Identification of markers of glucocorticoid-induced diabetes (diagnosed by HbA1c), using genomic and metabolomics measurements
Time Frame: 3 years
Genomic measurements will include whole blood methylome, transcriptome and miRNome. Metabolomic measurements will be performed by mass spectrometry in blood plasma and urine, to characterize a large panel of biochemical compounds. Relevant markers identified with these high throughput methods will be combined into a single multidimensional composite predictor.
3 years
Identification of markers of glucocorticoid-induced osteoporosis (diagnosed by bone density test), using genomic and metabolomics measurements
Time Frame: 3 years
Genomic measurements will include whole blood methylome, transcriptome and miRNome. Metabolomic measurements will be performed by mass spectrometry in blood plasma and urine, to characterize a large panel of biochemical compounds. Relevant markers identified with these high throughput methods will be combined into a single multidimensional composite predictor.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identification of markers of glucocorticoid-induced depression (diagnosed by a psychiatrist evaluation during routine management), using genomic and metabolomics measurements
Time Frame: 3 years
Genomic measurements will include whole blood methylome, transcriptome and miRNome. Metabolomic measurements will be performed by mass spectrometry in blood plasma and urine, to characterize a large panel of biochemical compounds. Relevant markers identified with these high throughput methods will be combined into a single multidimensional composite predictor.
3 years
Identification of markers of glucocorticoid-induced hypercatabolism (diagnosed clinically: bruising, stretch marks and amyotrophy), using genomic and metabolomics measurements
Time Frame: 3 years
Genomic measurements will include whole blood methylome, transcriptome and miRNome. Metabolomic measurements will be performed by mass spectrometry in blood plasma and urine, to characterize a large panel of biochemical compounds. Relevant markers identified with these high throughput methods will be combined into a single multidimensional composite predictor.
3 years
Identification of markers of glucocorticoid-induced abnormal fat distribution (diagnosed clinically), using genomic and metabolomics measurements
Time Frame: 3 years
Genomic measurements will include whole blood methylome, transcriptome and miRNome. Metabolomic measurements will be performed by mass spectrometry in blood plasma and urine, to characterize a large panel of biochemical compounds. Relevant markers identified with these high throughput methods will be combined into a single multidimensional composite predictor.
3 years
Identification of markers of glucocorticoid-induced thromboembolic episode (diagnosed during routine management), using genomic and metabolomics measurements
Time Frame: 3 years
Genomic measurements will include whole blood methylome, transcriptome and miRNome. Metabolomic measurements will be performed by mass spectrometry in blood plasma and urine, to characterize a large panel of biochemical compounds. Relevant markers identified with these high throughput methods will be combined into a single multidimensional composite predictor.
3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
URC-CIC Paris Descartes Necker Cochin
European Union's Horizon 2020 research and innovation programme under grant agreement No 633983

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP190799
  • 2020-A02714-35 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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