NCT05966727

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Mar 2025Jun 2026

First Submitted

Initial submission to the registry

July 5, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 19, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2026

Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

July 5, 2023

Last Update Submit

March 21, 2025

Conditions

Obesity, AbdominalDiabetesBariatric Surgery Candidate

Keywords

endocrine disrupterObesityDiabetesBariatric Surgery

Outcome Measures

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.

    19 month

Secondary Outcomes (1)

  • Measurement of serum POPs concentrations by mass spectrometry after bariatric surgery

    19 month

Study Arms (1)

Cholestyramine intake

EXPERIMENTAL

1 sachet (4 grams) 3 times a day, corresponding to a daily dose of 12 grams. Preferably taken at mealtimes. Treatment lasts 4 months.

Drug: Cholestyramine Powder

Interventions

Cholestyramine PowderDRUG

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

Also known as: Questran
Cholestyramine intake

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • Phenylketonuria
  • Inability to give consent
  • Patient under legal protection (guardianship, curatorship, safeguard of justice...)
  • Patient deprived of liberty by judicial or administrative decision,
  • Patients under psychiatric care which makes it impossible for them to consent to participation, or who are hospitalized under duress.
  • Participation in another interventional study (outside the PaCO project).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nice - Hôpital de l'Archet 2

Nice, Alpes-Mritimes, 06300, France

RECRUITING

MeSH Terms

Conditions

Obesity, AbdominalDiabetes MellitusObesity

Interventions

Cholestyramine Resin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PolystyrenesPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Nicolas CHEVALIER

    CHU NICE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas CHEVALIER

CONTACT

04 92 03 55 19chevalier.n@chu-nice.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

August 1, 2023

Study Start

March 19, 2025

Primary Completion (Estimated)

June 19, 2026

Study Completion (Estimated)

June 19, 2026

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations

FR(1)