Exploring the link between childhood trauma and obesity in women
Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
This study is trying to see if women who experienced childhood trauma have different stress and inflammation levels that could be linked to obesity compared to those who didn’t have such experiences.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 1 site (Limoges) |
| Trial ID | NCT05237440 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between childhood traumas and the deregulation of the glucocorticoid axis and inflammatory responses in obese women. It aims to compare the salivary cortisol awakening response in participants with and without a history of childhood trauma, assessed using the Childhood Trauma Questionnaire. The research will also evaluate the biological markers of stress and inflammation through various methods, including cortisol measurement in saliva, urine, and hair, as well as blood tests for pro-inflammatory cytokines. By understanding these associations, the study seeks to uncover underlying factors contributing to obesity beyond energy balance.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a BMI of 30 kg/m² or higher.
Not a fit: Patients with a history of bariatric surgery or conditions affecting the corticotropic axis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for obesity by addressing psychological and biological factors linked to childhood trauma.
How similar studies have performed: While the association between childhood trauma and obesity has been established, this specific approach focusing on biological markers is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Limoges
- LimogesUniversity Hospital — Limoges, France (Recruiting)
Study contacts
- Study coordinator: Laurence SALLE, MD
- Email: laurence.salle@chu-limoges.fr
- Phone: 555049818
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.