NCT05237440 Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
| NCT ID | NCT05237440 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Limoges |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2022-04-13 |
| Primary Completion | 2027-05-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2022-04-13 with a primary completion date of 2027-05-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
We postulate that childhood traumas are associated with deregulation of the glucocorticoid axis and the inflammatory system in obese women. The main objective of the study is to compare the salivary cortisol awaking response in obese women according to the presence of childhood trauma (assessed using the Childhood Trauma Questionnaire, CTQ).
Eligibility Criteria
Inclusion Criteria: * ≥18 years female BMI≥30kg/m2 Exclusion Criteria: 1. History of bariatric surgery 2. Any condition or pathology that may influence the corticotropic axis or that may modify the excretion or dosage of cortisol: * pregnancy, breastfeeding * hepatocellular insufficiency, * severe heart failure, * mild/moderate acute heart failure, * any psychological disorder not stabilised for at least one year * alcohol or drug dependence, not weaned for at least one year * neoplasm under treatment 3. Current infectious disease or a history of autoimmune disease (except autoimmune hypothyroidism), inflammatory disease and/or neurodegenerative disease 4. Presence of an adrenal adenoma or any known or suspected clinical adrenal or corticotropic disorder 5. Subjects with a positive diagnosis of hypercorticism or suspected hypercorticism will also be excluded: 8-hour plasma cortisol after Dexamethasone suppression test (DST) (1 mg dexamethasone taken orally at midnight the previous day) greater than 1.8 microg/100 ml (50 nmol/l) 6. antidepressant and neuroleptic treatment, benzodiazepine treatment 7. treatment(s) likely to modify the exploration of the corticotropic axis: systemic or local corticosteroid therapy or glucocorticoid infiltration for less than 6 months 8. current use of anti-inflammatory drugs or antibiotics 9. Shift worker
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05237440 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05237440 currently recruiting?
Yes, NCT05237440 is actively recruiting participants. Contact the research team at laurence.salle@chu-limoges.fr for enrollment information.
Where is the NCT05237440 trial being conducted?
This trial is being conducted at Limoges, France.
Who is sponsoring the NCT05237440 clinical trial?
NCT05237440 is sponsored by University Hospital, Limoges. The trial plans to enroll 102 participants.
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