Evaluating Cholestyramine's Effect on Obese Women Before Bariatric Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of cholestyramine treatment on the serum levels of persistent organic pollutants (POPs) in obese female patients who are candidates for bariatric surgery. The research aims to determine if cholestyramine can effectively reduce the preoperative load of POPs, which are known to accumulate in fatty tissues and may affect health outcomes. By administering this treatment prior to surgery, the study seeks to minimize the release of POPs during the rapid weight loss that follows bariatric procedures. The trial includes female participants aged 18 to 45 with specific obesity criteria and requires informed consent for participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patients with a retained indication for bariatric surgery (BMI \> 40 kg/m2 or BMI \> 35 kg/m2 with complication(s) amenable to improvement by surgery)
* Aged between 18 and 45
* Using effective contraception (oral contraception, hormonal or non-hormonal intrauterine device, progestin implant), which will be adapted in the perioperative period in accordance with current recommendations (HAS, BARIA-MAT)
* Affiliated to a social security scheme
* Have signed an informed consent form

Exclusion Criteria:

* Pregnant (urine pregnancy test) or breast-feeding women
* Known allergy or intolerance to cholestyramine
* Chronic constipation
* Chronic pathology likely to interfere with treatment efficacy (unbalanced diabetes characterized by HbA1c \> 7%, known and treated dyslipidemia, chronic renal insufficiency with GFR \< 60 ml/min, hepatocellular insufficiency)
* Patients receiving anti-vitamin K, digoxin or levothyroxine therapy, or likely to receive such therapy within 3 months of inclusion.
* Phenylketonuria
* Inability to give consent
* Patient under legal protection (guardianship, curatorship, safeguard of justice...)
* Patient deprived of liberty by judicial or administrative decision,
* Patients under psychiatric care which makes it impossible for them to consent to participation, or who are hospitalized under duress.
* Participation in another interventional study (outside the PaCO project).

Where it's running

• CHU Nice - Hôpital de l'Archet 2
  Nice, Alpes-Mritimes, France Recruiting

Study contacts

• Principal investigator: Nicolas CHEVALIER — Centre Hospitalier Universitaire de Nice
• Study coordinator: Nicolas CHEVALIER
• Email: chevalier.n@chu-nice.fr
• Phone: 04 92 03 55 19

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.