ObesityOBEVIENCT05237440
Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
A study testing Biological dosage in people with Obesity, run by University Hospital, Limoges at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Biological dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2022to 13 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years female BMI≥30kg/m2
Who cannot join
- 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,
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
LimogesUniversity Hospital
Limoges, 87049
Laurence SALLE, MD, laurence.salle@chu-limoges.fr
Laurence SALLE, MD
About this study
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).
Read the 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.
- Conditions
- Obesity
- Being tested
- Biological dosage
- Keywords
- obesity, childhood trauma, hypothalamic-pituitary-adrenal axis, inflammation, metabolic syndrome
- Medical subject headings
- Obesity, Inflammation, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological dosageBiological
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
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | 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 Receives: Biological: Biological dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (10)
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)
Measured: Day 21
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)
Measured: Day 21
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)
Measured: Day 21
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)
Measured: Day 21
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.
Measured: Day 0
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)
Measured: Day 0
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)
Measured: 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)
Comparison of the parameters of inflammation in obese women according to the presence of childhood trauma (assessed using CTQ)
Measured: Day 21
comparison of body composition
comparison of body composition in obese women by biphotonic absorptiometry according to the presence of childhood trauma (assessed using CTQ)
Measured: Day -7
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)
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start13 Apr 2022
- Primary completion13 May 2027 (estimated)
- Study completion13 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237440
- Sponsor's protocol ID
- 87RI21_0055 (OBEVIE)
- Acronym
- OBEVIE
- Status last verified
- Jun 2026
- First submitted
- 7 Jan 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Traumas in Obese Women: Association With Deregulation of the Glucocorticoid Axis and Inflammatory State.
- ClinicalTrials.gov ID
- NCT05237440
- Acronym / sponsor ID
- OBEVIE / 87RI21_0055 (OBEVIE)
- Conditions
- Obesity
- Keywords
- obesity, childhood trauma, hypothalamic-pituitary-adrenal axis, inflammation, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 13 May 2027 (estimated)
- Study completion
- 13 May 2027 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Biological: Biological dosageMetabolic, 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥18 years female BMI≥30kg/m2
Key exclusion criteria (16 listed)
- History of bariatric surgery
- Any condition or pathology that may influence the corticotropic axis or that may modify the excretion or dosage of cortisol:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological dosageMetabolic, 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 | Biological | All patients |
Primary outcome
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
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological dosage in people with Obesity, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurence SALLE, MD (555049818 ext. +33, laurence.salle@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of salivary cortisol awakening response (CAR) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.