Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients

• Conditions: Obesity
• Interventions: Other: Blood and urine collection

• Registration Number: NCT04844684
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-17
• Study Start: 2022-06
• Primary Completion: 2024-05
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese/non-diabetic patients undergoing gastric bypass surgery	Blood and urine collection	-

Primary Outcome Measures

Name	Time	Method
Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB	At 1 year

Secondary Outcome Measures

Name	Time	Method
Urinary cortisol metabolite profile modification	At 1 month after RYGP, at 1 year after RYGP
Urinary and plasmatic BA profile modification	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	at 1 year