ObesityCORTABONCT04844684
Evaluation of Cortisol and Bile Acids Metabolism in Obese Patients
An observational study of Obesity, run by University Hospital, Lille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Blood and urine collection
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2023to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for bariatric surgery in the department of endocrine surgery at Lille University Hospital
Who may be able to join
- Non-menopausal women
- BMI between 35 and 50 kg/m² included
- Social insured
- Ability to give consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Huriez - Service d'endocrinologie, diabétologie, nutrition et métabolisme
Lille
Stéphanie ESPIARD
About this study
Official title: Link Between the Metabolism of Cortisol and Bile Acids in Obese Patients Before and After Bariatric Surgery
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
- Being tested
- Blood and urine collection
- Keywords
- Cortisol, Bile acids, Obesity, Bariatric surgery, Insulin resistance
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine collectionOther
Blood sampling urine collections before RYGP and 1 month and 1 year after.
| Study group | Role | What they receive |
|---|---|---|
| Obese/non-diabetic patients undergoing gastric bypass surgery | Not described Receives: Other: Blood and urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB
Measured: At 1 year
Secondary outcomes (3)
Urinary cortisol metabolite profile modification
Measured: At 1 month after RYGP, at 1 year after RYGP
Urinary and plasmatic BA profile modification
Measured: 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
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start30 Mar 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie ESPIARD, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844684
- Sponsor's protocol ID
- 2019_77
- Other IDs
- 2020-A03176-33
- Acronym
- CORTABO
- Status last verified
- Dec 2025
- First submitted
- 13 Apr 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Link Between the Metabolism of Cortisol and Bile Acids in Obese Patients Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04844684
- Acronym / sponsor ID
- CORTABO / 2019_77
- Conditions
- Obesity
- Keywords
- Cortisol, Bile acids, Obesity, Bariatric surgery, Insulin resistance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese/non-diabetic patients undergoing gastric bypass surgery | – | Other: Blood and urine collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for bariatric surgery in the department of endocrine surgery at Lille University Hospital
Key inclusion criteria (4 listed)
- Non-menopausal women
- BMI between 35 and 50 kg/m² included
- Social insured
- Ability to give consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and urine collectionBlood sampling urine collections before RYGP and 1 month and 1 year after. | Other | Obese/non-diabetic patients undergoing gastric bypass surgery |
Primary outcome
Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB
Time frame: At 1 year
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stéphanie ESPIARD, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie ESPIARD, MD (0320445962 ext. +33, stephanie.espiard@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the variations of urinary cortisol metabolites and plasmatic total BA level before and after RYGB (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.