Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients

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

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Blood and urine collection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obese/non-diabetic patients undergoing gastric bypass surgery<br> | Other: Blood and urine collection<br>* Blood sampling urine collections before RYGP and 1 month and 1 year after.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB |  | At 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cortisol, Bile acids, Obesity, Bariatric surgery, Insulin resistance