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Clinical Trials/NCT04844684
NCT04844684RecruitingNot Applicable

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

University Hospital, Lille1 site in 1 country30 target enrollmentStarted: March 30, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB

Time Frame: At 1 year

Secondary Outcomes

  • 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)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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