Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients
Recruiting · NCT05966727 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Nice
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- CHU Nice - Hôpital de l'Archet 2 - Nice, Alpes-Mritimes, France