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NCT Number: NCT05237440

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

LimogesUniversity Hospital

Limoges, 87049, France

Location status: Recruiting

Location contact

Laurence SALLE, MD

CONTACT

[email protected]

Laurence SALLE, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological dosage

Biological

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 outcomes

  1. Measurement of salivary cortisol awakening response (CAR)

    Time frame: 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 outcomes

  1. Comparison of the amount of urinary free cortisol

    Time frame: Day 21

    Comparison of the amount of urinary free cortisol in obese women according to the presence of childhood trauma (assessed using CTQs)

  2. Comparison of the amount of urinary free cortisol metabolites

    Time frame: Day 21

    Comparison of the amount of urinary free cortisol metabolites in obese women according to the presence of childhood trauma (assessed using CTQs)

  3. Comparison of the amount of salivary cortisone

    Time frame: Day 21

    Comparison of the amount of salivary cortisone in obese women according to the presence of childhood trauma (assessed using CTQs)

  4. Comparison of the amount of hair cortisol/cortisone

    Time frame: Day 21

    Comparison of the amount of hair cortisol/cortisone in obese women according to the presence of childhood trauma (assessed using CTQs)

  5. comparison of the proportions of current anxiety/depression

    Time frame: 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.

  6. comparison of the proportions of current post-traumatic stress disorder (PTSD)

    Time frame: 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)

  7. comparison of the proportion of current eating disorders

    Time frame: 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)

  8. 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 the parameters of inflammation in obese women according to the presence of childhood trauma (assessed using CTQ)

  9. comparison of body composition

    Time frame: Day -7

    comparison of body composition in obese women by biphotonic absorptiometry according to the presence of childhood trauma (assessed using CTQ)

  10. Comparison of the choice of treatment modality

    Time frame: Day 21

    Comparison of the choice of treatment modality (medical or surgical) according to the presence of childhood trauma (assessed using CTQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Laurence SALLE, MD

CONTACT

[email protected]

555049818 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: OBEVIE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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