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

Sponsor

University Hospital, Limoges (Other)

Overall Status

Recruiting

CT.gov ID

NCT05237440

Collaborator

(none)

102

Enrollment

Location

Arm

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Obesity	Biological: Biological dosage	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Apr 13, 2022

Anticipated Primary Completion Date :

May 13, 2024

Anticipated Study Completion Date :

May 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: All patients Metabolic, hormonal and psychometric evaluations will be carried out during or after hospitalization inflammatory parameters, hormonal, capillary, saliva and urine assays will also be carried out	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

Arm

Intervention/Treatment

Other: All patients

Metabolic, hormonal and psychometric evaluations will be carried out during or after hospitalization inflammatory parameters, hormonal, capillary, saliva and urine assays will also be carried out

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of the amount of urinary free cortisol [Day 21]
Comparison of the amount of urinary free cortisol in obese women according to the presence of childhood trauma (assessed using CTQs)
Comparison of the amount of urinary free cortisol metabolites [Day 21]
Comparison of the amount of urinary free cortisol metabolites in obese women according to the presence of childhood trauma (assessed using CTQs)
Comparison of the amount of salivary cortisone [Day 21]
Comparison of the amount of salivary cortisone in obese women according to the presence of childhood trauma (assessed using CTQs)
Comparison of the amount of hair cortisol/cortisone [Day 21]
Comparison of the amount of hair cortisol/cortisone in obese women according to the presence of childhood trauma (assessed using CTQs)
comparison of the proportions of current anxiety/depression [Day 0]
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.
comparison of the proportions of current post-traumatic stress disorder (PTSD) [Day 0]
comparison of the proportions of current post-traumatic stress disorder with PCL-5 scale according to the presence of childhood trauma (assessed using CTQs)
comparison of the proportion of current eating disorders [Day 0]
comparison of the proportion of current eating disorders with Dutch Eating Behavior Questionnaire according to the presence of childhood trauma (assessed using CTQs)
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) [Day 21]
Comparison of the parameters of inflammation in obese women according to the presence of childhood trauma (assessed using CTQ)
comparison of body composition [Day -7]
comparison of body composition in obese women by biphotonic absorptiometry according to the presence of childhood trauma (assessed using CTQ)
Comparison of the choice of treatment modality [Day 21]
Comparison of the choice of treatment modality (medical or surgical) according to the presence of childhood trauma (assessed using CTQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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