Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients (CORTABO)

December 17, 2025 updated by: University Hospital, Lille

Link Between the Metabolism of Cortisol and Bile Acids in Obese Patients Before and After Bariatric Surgery

Bariatric surgery is currently the most efficient treatment for obesity. The sustained weight loss and metabolic improvement seen following Roux-en-Y gastric bypass (RYGB), is explained partly by modifications in hormones including bile acids (BA). After RYGB, an increased total BA pool and a reduction in hepatic cortisol exposure is observed. Hydroxysteroid 11-β dehydrogenase 1 (HSD11B1), steroid 5α-reductases (SRD5A), and steroid 5β-reductases, AKR1D1 (also a BA metabolizing enzyme), are three enzymes involved in the metabolism of cortisol in the liver and are known to participate in metabolic syndrome. Their activity has been shown to be decreased after RYGB. Interestingly, the mechanisms explaining the modification of hepatic cortisol exposure and the activity of theses enzymes after RYGB are unknown. In view of the few data suggesting a link between cortisol metabolism and bile acids, this work aim to study and characterize this link in a context of RYBP

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Hôpital Huriez - Service d'endocrinologie, diabétologie, nutrition et métabolisme
        • Contact:
          • Stéphanie ESPIARD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted for bariatric surgery in the department of endocrine surgery at Lille University Hospital

Description

Inclusion Criteria:

  • Non-menopausal women
  • BMI between 35 and 50 kg/m² included
  • Social insured
  • Ability to give consent

Exclusion Criteria:

  • moderate and severe kidney insufficiency
  • hepatic insufficiency
  • known gallbladder lithiasis
  • history of cholecystectomy or cholecystectomy planned during the gastric bypass
  • history of bariatric surgery except gastric band and gastric balloon
  • history of type 1
  • treatment interfering with the cortisol metabolism: taking oral or inhaled glucocorticoids within the last 6 months
  • treatment by BA as ursodeoxycholic acid, bile acids sequester, statin, fibrate stopped less than 4 weeks ago

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obese/non-diabetic patients undergoing gastric bypass surgery
Other: Blood and urine collection
Blood sampling urine collections before RYGP and 1 month and 1 year after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB
Time Frame: At 1 year
At 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary cortisol metabolite profile modification
Time Frame: At 1 month after RYGP, at 1 year after RYGP
At 1 month after RYGP, at 1 year after RYGP
Urinary and plasmatic BA profile modification
Time Frame: At 1 month after RYGP, at 1 year after RYGP
At 1 month after RYGP, at 1 year after RYGP
Correlation between the variations of cortisol metabolites and the variations of metabolic parameters 1 year after gastric bypass
Time Frame: at 1 year
at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Stéphanie ESPIARD, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_77
  • 2020-A03176-33 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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