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NCT Number: NCT04844684

Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients

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

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Lille, France

Location status: Recruiting

Location contact

Stéphanie ESPIARD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and Urine Collection

Other

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

Primary outcomes

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

    Time frame: At 1 year

Secondary outcomes

  1. Urinary cortisol metabolite profile modification

    Time frame: At 1 month after RYGP, at 1 year after RYGP

  2. Urinary and plasmatic BA profile modification

    Time frame: At 1 month after RYGP, at 1 year after RYGP

  3. Correlation between the variations of cortisol metabolites and the variations of metabolic parameters 1 year after gastric bypass

    Time frame: at 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphanie ESPIARD, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: CORTABO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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