Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
Recruiting · NCT05237440 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Biological dosage
What this trial 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).
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥18 years female BMI≥30kg/m2
Exclusion criteria
- History of bariatric surgery
- 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
- Current infectious disease or a history of autoimmune disease (except autoimmune hypothyroidism), inflammatory disease and/or neurodegenerative disease
- Presence of an adrenal adenoma or any known or suspected clinical adrenal or corticotropic disorder
- 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)
- antidepressant and neuroleptic treatment, benzodiazepine treatment
- treatment(s) likely to modify the exploration of the corticotropic axis: systemic or local corticosteroid therapy or glucocorticoid infiltration for less than 6 months
- current use of anti-inflammatory drugs or antibiotics
- Shift worker
Where it is running
1 location listed.
- LimogesUniversity Hospital - Limoges, France