Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients

NCT04844684 | Recruiting

• 2 other identifiers: 2019_772020-A03176-33
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

Cortisol; Bile acids; Obesity; Bariatric surgery; Insulin resistance

Outcome Measures

Primary Outcomes (1)

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

  At 1 year

Secondary Outcomes (3)

• 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

Study Arms (1)

Obese/non-diabetic patients undergoing gastric bypass surgery

Other: Blood and urine collection

Interventions

Blood and urine collection OTHER

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

Obese/non-diabetic patients undergoing gastric bypass surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women obese patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted for bariatric surgery in the department of endocrine surgery at Lille University Hospital

You may qualify if:

• Non-menopausal women
• BMI between 35 and 50 kg/m² included
• Social insured
• Ability to give consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

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

Lille, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood (EDTA 3 mL), serum, 24 hours urine (before RYGB, 1 month and 1 year after RYGB, liver tissue, adipose tissue

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Blood Specimen Collection; Urine Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Stéphanie ESPIARD, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie ESPIARD, MD

CONTACT

0320445962; stephanie.espiard@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 14, 2021
• Study Start: March 30, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

FR (1)