NCT05966727Recruiting
Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients
Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of Persistent Organic Pollutants in Obese Female Patients - OBESE (OBesity, CholEStyramine, WomEn)
Source: ClinicalTrials.gov · Last updated 24 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 5 Jul 2023
- Start date
- Mar 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Obesity
- NCT number
- NCT05966727
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Mar 2025 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving anti-vitamin K, digoxin or levothyroxine therapy, or likely to receive such therapy within 3 months of inclusion.
Other illness
- Known allergy or intolerance to cholestyramine
- Patients under psychiatric care which makes it impossible for them to consent to participation, or who are hospitalized under duress.
Lab values
- 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)
Other
- Pregnant (urine pregnancy test) or breast-feeding women
- Chronic constipation
- Phenylketonuria
- Inability to give consent
- Patient under legal protection (guardianship, curatorship, safeguard of justice...)
- Patient deprived of liberty by judicial or administrative decision,
- Participation in another interventional study (outside the PaCO project).
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Nice - Hopital de l Archet 2 Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.