Identifying markers for complications of glucocorticoid excess
Genomic and Metabolomic Markers Reflecting the Complications of Hypercortisolism
This study is trying to find specific markers in blood, urine, and saliva that can help predict complications like diabetes and high blood pressure in people who have too much cortisol in their bodies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04840693 on ClinicalTrials.gov |
What this trial studies
This study aims to identify genomic and metabolomic markers associated with complications arising from hypercortisolism, such as diabetes, hypertension, and osteoporosis. Participants will provide biological samples, including blood, urine, and saliva, which will be analyzed to find specific molecular signatures linked to these complications. The study will involve comparing affected patients with those who do not have glucocorticoid excess and testing the performance of identified markers in different patient cohorts. The ultimate goal is to better predict individual risks for these complications in patients with glucocorticoid exposure.
Who should consider this trial
Good fit: Ideal candidates include individuals with endogenous hypercortisolism, those starting glucocorticoid therapy, chronic adrenal insufficiency patients, or individuals with diabetes, hypertension, or osteoporosis without glucocorticoid excess.
Not a fit: Patients with a reduced life expectancy of less than 2 years, pregnant or lactating women, or those refusing the protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized risk assessments for patients with glucocorticoid excess, improving management and outcomes.
How similar studies have performed: While the approach of identifying specific markers for complications of glucocorticoid excess is innovative, similar studies have shown promise in understanding the effects of glucocorticoids on health.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Hôpital Cochin — Paris, France (Recruiting)
Study contacts
- Study coordinator: Guillaume ASSIE, PhD
- Email: guillaume.assie@aphp.fr
- Phone: + 33 1 58 41 18 40
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.