Evaluating Cholestyramine's Effect on Obese Women Before Bariatric Surgery
Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of Persistent Organic Pollutants in Obese Female Patients - OBESE (OBesity, CholEStyramine, WomEn)
This study is testing if a medication called cholestyramine can help reduce harmful chemicals in the bodies of obese women before they have weight loss surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, Alpes-Mritimes) |
| Trial ID | NCT05966727 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are obese women aged 18 to 45 who are preparing for bariatric surgery and are using effective contraception.
Not a fit: Patients who are pregnant, breastfeeding, or have certain chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved health outcomes for obese women undergoing bariatric surgery by reducing harmful POP levels.
How similar studies have performed: While there have been studies on the effects of POPs in obesity, this specific approach using cholestyramine is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nice, Alpes-Mritimes
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.