Obesity Clinical Trial
— OBEVIEOfficial title:
Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
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).
Status | Recruiting |
Enrollment | 102 |
Est. completion date | May 13, 2024 |
Est. primary completion date | May 13, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | LimogesUniversity Hospital | Limoges |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement of salivary cortisol awakening response (CAR) | 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 | Day 0 | |
Secondary | Comparison of the amount of urinary free cortisol | Comparison of the amount of urinary free cortisol in obese women according to the presence of childhood trauma (assessed using CTQs) | Day 21 | |
Secondary | Comparison of the amount of urinary free cortisol metabolites | Comparison of the amount of urinary free cortisol metabolites in obese women according to the presence of childhood trauma (assessed using CTQs) | Day 21 | |
Secondary | Comparison of the amount of salivary cortisone | Comparison of the amount of salivary cortisone in obese women according to the presence of childhood trauma (assessed using CTQs) | Day 21 | |
Secondary | Comparison of the amount of hair cortisol/cortisone | Comparison of the amount of hair cortisol/cortisone in obese women according to the presence of childhood trauma (assessed using CTQs) | Day 21 | |
Secondary | comparison of the proportions of current anxiety/depression | comparison of the proportions of current anxiety/depression with Hospital Anxiety and Depression Scale according to the presence of childhood trauma (assessed using CTQs). This scale includes14 items rated from 0 to 3. Questions are separated in two categories, 7 for anxiety and 7 for depression. thus allowing 2 scores to be obtained with a maximum of 21 for each. | Day 0 | |
Secondary | comparison of the proportions of current post-traumatic stress disorder (PTSD) | comparison of the proportions of current post-traumatic stress disorder with PCL-5 scale according to the presence of childhood trauma (assessed using CTQs) | Day 0 | |
Secondary | comparison of the proportion of current eating disorders | comparison of the proportion of current eating disorders with Dutch Eating Behavior Questionnaire according to the presence of childhood trauma (assessed using CTQs) | Day 0 | |
Secondary | Dosage of several parameters of inflammation (CRP, IL-1beta, IFN-alpha2, IFN-gamma, TNF-alpha, CCL2 (MCP-1), IL-6, CXCL8 (IL-8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, l'IL-33, T lymphocytes and Myeloid-Derived Suppressor Cells immunophenotyping) | Comparison of the parameters of inflammation in obese women according to the presence of childhood trauma (assessed using CTQ) | Day 21 | |
Secondary | comparison of body composition | comparison of body composition in obese women by biphotonic absorptiometry according to the presence of childhood trauma (assessed using CTQ) | Day -7 | |
Secondary | Comparison of the choice of treatment modality | Comparison of the choice of treatment modality (medical or surgical) according to the presence of childhood trauma (assessed using CTQ) | Day 21 |
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