Tests cholestyramine to lower pollutant levels before weight-loss surgery
Tests cholestyramine in women with obesity who are planning bariatric surgery.
Plain-language title generated from the registry record
Registry title: Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients
Key facts
- Where
- Nice, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT05966727, who can take part
Where in France
- CHU Nice - Hopital de l Archet 2Nice, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Trial code
- NCT05966727
- Record updated
- 24 March 2025
- Original description
Environmental endocrine disruptors (EDCs) represent a major problem for human health.Some PEEs can accumulate in the fatty tissue of the human body thanks to their lipophilic nature, and are known as persistent organic pollutants (POPs).Read full original descriptionShow less
Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of Persistent Organic Pollutants in Obese Female Patients - OBESE (OBesity, CholEStyramine, WomEn)
Environmental endocrine disruptors (EDCs) represent a major problem for human health.Some PEEs can accumulate in the fatty tissue of the human body thanks to their lipophilic nature, and are known as persistent organic pollutants (POPs).
To assess the benefit of cholestyramine treatment on POPs blood levels in obese patients of childbearing age undergoing bariatric surgery, in order to reduce their preoperative POPs load more rapidly. Indeed, the investigators hypothesize that cholestyramine is capable, outside of acute exposure accidents, of promoting the elimination and release of POPs in the human population. Given this hypothesis, a treatment administered prior to bariatric surgery could reduce pre-operative plasma levels of POPs and thus, in fine, minimize the concentrations reached post-operatively, which are dependent on the release induced by lipolysis (massive and rapid weight loss) and pre-operative plasma concentrations.
Inclusion: 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: Patients receiving anti-vitamin K, digoxin or levothyroxine therapy, or likely to receive such therapy within 3 months of inclusion; Known allergy or intolerance to cholestyramine; Patients under psychiatric care which makes it impossible for them to consent to participation, or who are hospitalized under duress; 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); Pregnant (urine pregnancy test) or breast-feeding women; Chronic constipation; Phenylketonuria; Inability to give consent; Patient under legal protection (guardianship, curatorship, safeguard of justice...); Patient deprived of liberty by judicial or administrative decision,; Participation in another interventional study (outside the PaCO project).