Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients

Obesity Clinical Trial

— CORTABO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04844684
• Other study ID #: 2019_77
• Secondary ID: 2020-A03176-33
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: June 2024

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Stéphanie ESPIARD, MD
• Phone: 0320445962
• Email: stephanie.espiard[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Blood and urine collection
Blood sampling urine collections before RYGP and 1 month and 1 year after.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB		At 1 year
Secondary	Urinary cortisol metabolite profile modification		At 1 month after RYGP, at 1 year after RYGP
Secondary	Urinary and plasmatic BA profile modification		At 1 month after RYGP, at 1 year after RYGP
Secondary	Correlation between the variations of cortisol metabolites and the variations of metabolic parameters 1 year after gastric bypass		at 1 year