Clinical trial

Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.

Recruiting now · Not applicable · 1 countries · Registry ID NCT05237440

Recruiting nowNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionObesity

Full registry 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

Treatments and study arms

Biological dosage

Biological

Metabolic, hormonal and psychometric evaluations will be carried out during inclusion inflammatory parameters, hormonal, capillary, saliva and urine assays will also be carried out at inclusion

Primary outcomes

Measurement of salivary cortisol awakening response (CAR)Day 0

Two salivary sampling at Day 0. The CAR is defined as the difference between the value of salivary cortisol collected 30 minutes after waking up and that on waking

Study locations

1 locations were listed when this page was built. The first 40 are shown.

LimogesUniversity Hospital🇫🇷 Limoges, France
Laurence SALLE, MDContact
Laurence SALLE, MDPrincipal Investigator