NCT04844684 Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients
| NCT ID | NCT04844684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Obesity |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-03-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-03-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Stéphanie ESPIARD, MD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04844684 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04844684 currently recruiting?
Yes, NCT04844684 is actively recruiting participants. Contact the research team at stephanie.espiard@chru-lille.fr for enrollment information.
Where is the NCT04844684 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04844684 clinical trial?
NCT04844684 is sponsored by University Hospital, Lille. The principal investigator is Stéphanie ESPIARD, MD at University Hospital, Lille. The trial plans to enroll 30 participants.
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