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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Cholestyramine Powder

    Drug

    Bile salt chelating resin, used as a lipid-lowering treatment.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Cholestyramine intakeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measurement of serum persistent organic pollutants (POPs) concentrations by mass spectrometry.

Evaluation of the effect of cholestyramine treatment on serum concentrations of various persistent organic pollutants (POPs) in a population of population of obese women of childbearing age for whom bariatric surgery is bariatric surgery is indicated.

Time frame
19 month

Secondary outcomes

1

Measurement of serum POPs concentrations by mass spectrometry after bariatric surgery

Evaluation of the effect of pre-operative cholestyramine treatment with respect to observed and expected post-bariatric surgery salting-out.

Time frame
19 month

Other outcomes

Sponsors and contacts

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