Actively Recruiting
Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients
Led by Centre Hospitalier Universitaire de Nice · Updated on 2025-03-24
20
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with a confirmed indication for bariatric surgery (BMI > 40 kg/m2 or BMI > 35 kg/m2 with complications that can improve with surgery)
- Aged between 18 and 45 years
- Using effective contraception (oral, hormonal or non-hormonal intrauterine device, or progestin implant) adapted for the perioperative period
- Affiliated to a social security scheme
- Have signed an informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women (confirmed by urine pregnancy test)
- Known allergy or intolerance to cholestyramine
- Chronic constipation
- Chronic diseases that may affect treatment effectiveness including unbalanced diabetes (HbA1c > 7%), treated dyslipidemia, chronic kidney failure (GFR < 60 ml/min), or liver failure
- Current or expected use within 3 months of anti-vitamin K, digoxin, or levothyroxine therapy
- Phenylketonuria
- Unable to give consent
- Under legal protection (guardianship, curatorship, safeguard of justice)
- Deprived of liberty by judicial or administrative decision
- Under psychiatric care preventing consent or hospitalized under duress
- Participation in another interventional study (outside the PaCO project)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Mritimes, France, 06300
Actively Recruiting
Research Team
N
Nicolas CHEVALIER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here