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

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Limoges

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years female BMI≥30kg/m2

Disqualifiers

History of bariatric surgery

pregnancy, breastfeeding

hepatocellular insufficiency,

severe heart failure,

Trial design

Design model

Single group

Treatments tested in this trial

  • Biological dosage

    Biological/Vaccine

    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

Treatment groups

102 Participants
are divided into 1 treatment group
Group A: All patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0

Secondary outcomes

1

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)

Time frame
Day 21
2

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)

Time frame
Day 21
3

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)

Time frame
Day 21
4

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)

Time frame
Day 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.