Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biological dosage.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
Obesity is an epidemic disease whose onset and development factors go beyond the simple energy balance. Current management strategies are often failing. It is therefore important to identify the underlying determinants of weight gain. The association of obesity in adulthood with trauma in childhood is now well established. However, the biological factors that account for this association are imperfectly known. The measurement of cortisol seems to be the most relevant biological marker of the link between obesity and life events. The majority of studies show that obesity is associated with increased exposure to glucocorticoids. However, some authors have recently reported that these measures are impacted by significant inter-individual variability which could be explained by differences in life events and especially in their perception. In addition, the autonomic nervous system with the secretion of catecholamines by the adrenal leads to the release of pro-inflammatory cytokines, resulting in a low grade inflammation.
The existence of childhood traumas and the association with other psychopathological disorders will be assessed using psychometric scales validated in French. The corticotropic axis will be evaluated by measuring cortisol in different matrices (saliva, urine, hair). The inflammatory state will be studied thanks to the determination of pro-inflammatory cytokines level in blood and immunophenotyping of myeloid-derived suppressor cells.
Interventions
- Biological 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
Primary outcome measures
- Measurement of salivary cortisol awakening response (CAR) [Time frame: Day 0]
Secondary outcome measures (10)
- Comparison of the amount of urinary free cortisol [Time frame: Day 21]
- Comparison of the amount of urinary free cortisol metabolites [Time frame: Day 21]
- Comparison of the amount of salivary cortisone [Time frame: Day 21]
- Comparison of the amount of hair cortisol/cortisone [Time frame: Day 21]
- comparison of the proportions of current anxiety/depression [Time frame: Day 0]
- comparison of the proportions of current post-traumatic stress disorder (PTSD) [Time frame: Day 0]
- comparison of the proportion of current eating disorders [Time frame: Day 0]
- 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) [Time frame: Day 21]
- comparison of body composition [Time frame: Day -7]
- Comparison of the choice of treatment modality [Time frame: Day 21]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- LimogesUniversity Hospital — Limoges
Identifiers
NCT: NCT05237440 · 87RI21_0055 (OBEVIE)