Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Cholestyramine Powder

Treatment groups

20 Participants
are divided into 1 treatment group