Cortisol and bile acid changes in people with obesity undergoing gastric bypass
Official title: Link Between the Metabolism of Cortisol and Bile Acids in Obese Patients Before and After Bariatric Surgery
Run by University Hospital, Lille · NCT04844684 · Data updated 2026-11-12
See if changes in bile acids after Roux-en-Y gastric bypass are linked to how the liver processes cortisol in non‑menopausal women with obesity.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille) |
| Status | Recruiting |
| Started | March 30, 2023 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT04844684 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are non‑menopausal women with BMI 35–50 kg/m² who are insured, able to consent, meet surgical candidacy for RYGB, and do not have excluded medical conditions or recent medications that alter cortisol or bile acid metabolism.
✕Probably not a fit
Men, postmenopausal women, people with BMI outside 35–50, those with type 1 diabetes, significant kidney or liver insufficiency, gallbladder disease, recent use of glucocorticoids or bile‑affecting drugs, or prior certain bariatric surgeries are unlikely to qualify or benefit from this specific study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study of non‑menopausal women with BMI 35–50 kg/m² who are undergoing Roux‑en‑Y gastric bypass. Researchers will collect blood and urine samples and measure bile acid profiles and markers of hepatic cortisol metabolism, including HSD11B1, SRD5A, and AKR1D1 activity. Samples will be compared around the time of surgery to characterize changes in bile acids and cortisol‑metabolizing enzyme activity. The goal is to define whether alterations in bile acids after surgery relate to reduced hepatic cortisol exposure and metabolic improvements.
Why it matters
Potential benefit: If successful, the findings could point to biological pathways that explain metabolic improvements after gastric bypass and suggest targets for new treatments that mimic those effects.
How similar studies have gone: Previous work has observed increased total bile acids and reduced hepatic cortisol exposure after RYGB and reported decreases in hepatic cortisol‑metabolizing enzymes, but the mechanistic link between bile acids and cortisol metabolism remains novel and not well established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hôpital Huriez - Service d'endocrinologie, diabétologie, nutrition et métabolisme
Lille, France Recruiting
Study contacts
- Principal investigator: Stéphanie ESPIARD, MD — University Hospital, Lille
- Study coordinator: Stéphanie ESPIARD, MD
- Email: stephanie.espiard@chru-lille.fr
- Phone: 0320445962
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.