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Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients

NCT ID: NCT04844684

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-30

Study Completion Date

2026-12-30

Brief Summary

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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

Detailed Description

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Conditions

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Obesity

Keywords

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Cortisol Bile acids Obesity Bariatric surgery Insulin resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese/non-diabetic patients undergoing gastric bypass surgery

Blood and urine collection

Intervention Type OTHER

Blood sampling urine collections before RYGP and 1 month and 1 year after.

Interventions

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Blood and urine collection

Blood sampling urine collections before RYGP and 1 month and 1 year after.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphanie ESPIARD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Huriez - Service d'endocrinologie, diabétologie, nutrition et métabolisme

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphanie ESPIARD, MD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Stéphanie ESPIARD

Role: primary

Other Identifiers

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2020-A03176-33

Identifier Type: OTHER

Identifier Source: secondary_id

2019_77

Identifier Type: -

Identifier Source: org_study_id