NCT05237440

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2024

Completed
Last Updated

September 14, 2023

Status Verified

September 1, 2023

Enrollment Period

2.1 years

First QC Date

January 7, 2022

Last Update Submit

September 13, 2023

Conditions

Obesity

Keywords

obesitychildhood traumahypothalamic-pituitary-adrenal axisinflammationmetabolic syndrome

Outcome Measures

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

    Day 0

Secondary Outcomes (10)

  • Comparison of the amount of urinary free cortisol

    Day 21

  • Comparison of the amount of urinary free cortisol metabolites

    Day 21

  • Comparison of the amount of salivary cortisone

    Day 21

  • Comparison of the amount of hair cortisol/cortisone

    Day 21

  • comparison of the proportions of current anxiety/depression

    Day 0

  • +5 more secondary outcomes

Study Arms (1)

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

Biological: Biological dosage

Interventions

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

All patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years female BMI≥30kg/m2

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LimogesUniversity Hospital

Limoges, 87049, France

RECRUITING

MeSH Terms

Conditions

ObesityInflammationMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Central Study Contacts

Laurence SALLE, MD

CONTACT

555049818laurence.salle@chu-limoges.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

February 14, 2022

Study Start

April 13, 2022

Primary Completion

May 13, 2024

Study Completion

May 13, 2024

Last Updated

September 14, 2023

Record last verified: 2023-09

Locations

FR(1)