Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of Persistent Organic Pollutants in Obese Female Patients - OBESE (OBesity, CholEStyramine, WomEn)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Nice - Hôpital de l'Archet 2
RECRUITING
Nice
Contact Information
Primary
Nicolas CHEVALIER
chevalier.n@chu-nice.fr
04 92 03 55 19
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2026-06-19
Participants
Target number of participants: 20
Treatments
Experimental: Cholestyramine intake
1 sachet (4 grams) 3 times a day, corresponding to a daily dose of 12 grams. Preferably taken at mealtimes.~Treatment lasts 4 months.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov