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

Primary Purpose

Obesity

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Biological dosage

About this trial

This is an interventional basic science trial for Obesity focused on measuring obesity, childhood trauma, hypothalamic-pituitary-adrenal axis, inflammation, metabolic syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

LimogesUniversity HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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)

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)

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)

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.

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)

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)

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)

comparison of body composition

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

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

Full Information

NCT ID

NCT05237440

First Posted

January 7, 2022

Last Updated

September 13, 2023

Sponsor

University Hospital, Limoges

1. Study Identification

Unique Protocol Identification Number

NCT05237440

Brief Title

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

Acronym

OBEVIE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 13, 2022 (Actual)

Primary Completion Date

May 13, 2024 (Anticipated)

Study Completion Date

May 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

obesity, childhood trauma, hypothalamic-pituitary-adrenal axis, inflammation, metabolic syndrome

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

All patients

Arm Type

Other

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Biological dosage

Intervention Description

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 Measure Information:

Title

Measurement of salivary cortisol awakening response (CAR)

Description

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 Outcome Measure Information:

Title

Comparison of the amount of urinary free cortisol

Description

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

Title

Comparison of the amount of urinary free cortisol metabolites

Description

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

Title

Comparison of the amount of salivary cortisone

Description

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

Time Frame

Day 21

Title

Comparison of the amount of hair cortisol/cortisone

Description

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

Title

comparison of the proportions of current anxiety/depression

Description

Time Frame

Day 0

Title

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

Description

comparison of the proportions of current post-traumatic stress disorder with PCL-5 scale according to the presence of childhood trauma (assessed using CTQs)

Time Frame

Day 0

Title

comparison of the proportion of current eating disorders

Description

comparison of the proportion of current eating disorders with Dutch Eating Behavior Questionnaire according to the presence of childhood trauma (assessed using CTQs)

Time Frame

Day 0

Title

Description

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

Time Frame

Day 21

Title

comparison of body composition

Description

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

Time Frame

Day -7

Title

Comparison of the choice of treatment modality

Description

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

Time Frame

Day 21

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laurence SALLE, MD

Phone

555049818

Ext

+33

laurence.salle@chu-limoges.fr

Facility Information:

Facility Name

LimogesUniversity Hospital

City

Limoges

ZIP/Postal Code

87049

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence SALLE, MD

laurence.salle@chu-limoges.fr

First Name & Middle Initial & Last Name & Degree

Laurence SALLE, MD

12. IPD Sharing Statement

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

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