Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and urine collection.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Link Between the Metabolism of Cortisol and Bile Acids in Obese Patients Before and After Bariatric Surgery
Overview
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
Interventions
- Other Blood and urine collection
Blood sampling urine collections before RYGP and 1 month and 1 year after.
Primary outcome measures
- Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB [Time frame: At 1 year]
Secondary outcome measures (3)
- Urinary cortisol metabolite profile modification [Time frame: At 1 month after RYGP, at 1 year after RYGP]
- Urinary and plasmatic BA profile modification [Time frame: 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 [Time frame: at 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Huriez - Service d'endocrinologie, diabétologie, nutrition et métabolisme — Lille
Identifiers
NCT: NCT04844684 · 2019_77 · 2020-A03176-33