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Recruiting Not applicable

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

NCT05237440 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-04-13
Last updated
2026-06-26

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Biological dosage

Biological dosage: 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

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
LimogesUniversity Hospital Limoges France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05237440 on ClinicalTrials.gov ↗ ← All trials in France