Adult Glucocorticoid ExcessCUSHINGOMICSNCT04840693
Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism (CUSHINGOMICS)
A study testing Biological samples and Complications in people with Adult Glucocorticoid Excess and Adult Adrenal Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Glucocorticoid Excess, Adult Adrenal Insufficiency
- What is being tested?
- Biological samples and Complications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with reduced life expectancy, less than 2 years
- pregnant or lactating women
- patients refusing the protocol
- patients under state medical assistance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Biological samples, Complications
- Keywords
- Hypercortisalism, Glucocorticoids excess, Cushing's syndrome
- Medical subject headings
- Adrenal Insufficiency, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesBiological
blood, urine, saliva
ComplicationsOther
bone mineral density, diabetes, hypertension, quality of life (quality of life questionnaire SF-36)
| Study group | Role | What they receive |
|---|---|---|
| Excess of endogenous glucoglucocorticoids (group 1) | Experimental | v Receives: Biological: Biological samples; Other: Complications |
| Exogenous hypercortisolisms (group 2) | Experimental | a disease justifying the up-coming start of a glucocorticoid therapy Receives: Biological: Biological samples; Other: Complications |
| Adrenal insufficiency (group 3) | Experimental | chronic adrenal insufficiency Receives: Biological: Biological samples; Other: Complications |
| Control (group 4) | Other | without glucocorticoid excess Receives: Biological: Biological samples; Other: Complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of molecular markers of glucocorticoid-induced hypertension (diagnosed by oscillometric blood pressure), using genomic and metabolomics measurements
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.
Measured: 3 years
Identification of markers of glucocorticoid-induced diabetes (diagnosed by HbA1c), using genomic and metabolomics measurements
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.
Measured: 3 years
Identification of markers of glucocorticoid-induced osteoporosis (diagnosed by bone density test), using genomic and metabolomics measurements
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.
Measured: 3 years
Secondary outcomes (4)
Identification of markers of glucocorticoid-induced depression (diagnosed by a psychiatrist evaluation during routine management), using genomic and metabolomics measurements
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.
Measured: 3 years
Identification of markers of glucocorticoid-induced hypercatabolism (diagnosed clinically: bruising, stretch marks and amyotrophy), using genomic and metabolomics measurements
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.
Measured: 3 years
Identification of markers of glucocorticoid-induced abnormal fat distribution (diagnosed clinically), using genomic and metabolomics measurements
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.
Measured: 3 years
Identification of markers of glucocorticoid-induced thromboembolic episode (diagnosed during routine management), using genomic and metabolomics measurements
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adult Glucocorticoid ExcessStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- European Union's Horizon 2020 research and innovation programme under grant agreement No 633983, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840693
- Sponsor's protocol ID
- APHP190799
- Other IDs
- 2020-A02714-35
- Acronym
- CUSHINGOMICS
- Status last verified
- May 2026
- First submitted
- 12 Jan 2021
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Newell-Price J, Bertagna X, Grossman AB, Nieman LK. Cushing's syndrome. Lancet. 2006 May 13;367(9522):1605-17. doi: 10.1016/S0140-6736(06)68699-6.
PubMed 16698415Charmandari E, Nicolaides NC, Chrousos GP. Adrenal insufficiency. Lancet. 2014 Jun 21;383(9935):2152-67. doi: 10.1016/S0140-6736(13)61684-0. Epub 2014 Feb 4.
PubMed 24503135Overman RA, Yeh JY, Deal CL. Prevalence of oral glucocorticoid usage in the United States: a general population perspective. Arthritis Care Res (Hoboken). 2013 Feb;65(2):294-8. doi: 10.1002/acr.21796.
PubMed 22807233Fardet L, Petersen I, Nazareth I. Risk of cardiovascular events in people prescribed glucocorticoids with iatrogenic Cushing's syndrome: cohort study. BMJ. 2012 Jul 30;345:e4928. doi: 10.1136/bmj.e4928.
PubMed 22846415Tauchmanova L, Rossi R, Biondi B, Pulcrano M, Nuzzo V, Palmieri EA, Fazio S, Lombardi G. Patients with subclinical Cushing's syndrome due to adrenal adenoma have increased cardiovascular risk. J Clin Endocrinol Metab. 2002 Nov;87(11):4872-8. doi: 10.1210/jc.2001-011766.
PubMed 12414841
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism
- ClinicalTrials.gov ID
- NCT04840693
- Acronym / sponsor ID
- CUSHINGOMICS / APHP190799
- Keywords
- Hypercortisalism, Glucocorticoids excess, Cushing's syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- European Union's Horizon 2020 research and innovation programme under grant agreement No 633983, URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Excess of endogenous glucoglucocorticoids (group 1) | Experimental | Biological: Biological samples, Other: Complicationsv |
| Exogenous hypercortisolisms (group 2) | Experimental | Biological: Biological samples, Other: Complicationsa disease justifying the up-coming start of a glucocorticoid therapy |
| Adrenal insufficiency (group 3) | Experimental | Biological: Biological samples, Other: Complicationschronic adrenal insufficiency |
| Control (group 4) | Other | Biological: Biological samples, Other: Complicationswithout glucocorticoid excess |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- patients with reduced life expectancy, less than 2 years
- pregnant or lactating women
- patients refusing the protocol
- patients under state medical assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samplesblood, urine, saliva | Biological | Adrenal insufficiency (group 3), Control (group 4), Excess of endogenous glucoglucocorticoids (group 1), Exogenous hypercortisolisms (group 2) |
| Complicationsbone mineral density, diabetes, hypertension, quality of life (quality of life questionnaire SF-36) | Other | Adrenal insufficiency (group 3), Control (group 4), Excess of endogenous glucoglucocorticoids (group 1), Exogenous hypercortisolisms (group 2) |
Primary outcome
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.
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.
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.
4 secondary outcomes
Identification of markers of glucocorticoid-induced depression (diagnosed by a psychiatrist evaluation during routine management), using genomic and metabolomics measurements
Time frame: 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
Identification of markers of glucocorticoid-induced abnormal fat distribution (diagnosed clinically), using genomic and metabolomics measurements
Time frame: 3 years
Identification of markers of glucocorticoid-induced thromboembolic episode (diagnosed during routine management), using genomic and metabolomics measurements
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 16698415Newell-Price J, Bertagna X, Grossman AB, Nieman LK. Cushing's syndrome. Lancet. 2006 May 13;367(9522):1605-17. doi: 10.1016/S0140-6736(06)68699-6.
- Background: PubMed 24503135Charmandari E, Nicolaides NC, Chrousos GP. Adrenal insufficiency. Lancet. 2014 Jun 21;383(9935):2152-67. doi: 10.1016/S0140-6736(13)61684-0. Epub 2014 Feb 4.
- Background: PubMed 22807233Overman RA, Yeh JY, Deal CL. Prevalence of oral glucocorticoid usage in the United States: a general population perspective. Arthritis Care Res (Hoboken). 2013 Feb;65(2):294-8. doi: 10.1002/acr.21796.
- Background: PubMed 22846415Fardet L, Petersen I, Nazareth I. Risk of cardiovascular events in people prescribed glucocorticoids with iatrogenic Cushing's syndrome: cohort study. BMJ. 2012 Jul 30;345:e4928. doi: 10.1136/bmj.e4928.
- Background: PubMed 12414841Tauchmanova L, Rossi R, Biondi B, Pulcrano M, Nuzzo V, Palmieri EA, Fazio S, Lombardi G. Patients with subclinical Cushing's syndrome due to adrenal adenoma have increased cardiovascular risk. J Clin Endocrinol Metab. 2002 Nov;87(11):4872-8. doi: 10.1210/jc.2001-011766.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples and Complications in people with Adult Glucocorticoid Excess and Adult Adrenal Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of molecular markers of glucocorticoid-induced hypertension (diagnosed by oscillometric blood pressure), using genomic and metabolomics measurements (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840693, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.