Status:
RECRUITING
Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Obesity, Abdominal
Diabetes
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 ...
Detailed Description
Environmental endocrine disruptors (EDCs) represent a major problem for human health. These chemical compounds from industry (pesticides, paints, plastics, etc.) are present in our daily lives, with e...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Patients receiving anti-vitamin K, digoxin or levothyroxine therapy, or likely to receive such therapy within 3 months of inclusion.
- 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).
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 19 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05966727
Start Date
March 19 2025
End Date
June 19 2026
Last Update
March 24 2025
Active Locations (1)
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1
CHU Nice - Hôpital de l'Archet 2
Nice, Alpes-Mritimes, France, 06300