Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jul 28, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how a medication called cholestyramine can help reduce certain harmful chemicals, known as persistent organic pollutants (POPs), in the blood of obese women who are preparing for weight loss surgery (bariatric surgery). The researchers believe that cholestyramine may help the body get rid of these pollutants more quickly, potentially leading to better health outcomes after surgery. By lowering the levels of POPs before the surgery, the hope is to minimize their effects on the body during and after the weight loss process.

To be eligible for this study, participants need to be female, between the ages of 18 and 45, and have a body mass index (BMI) that qualifies them for bariatric surgery. They must also be using effective birth control and be able to provide informed consent to participate. Women who are pregnant, breastfeeding, or have certain medical conditions that could affect the treatment are not eligible. Those who join the study can expect close monitoring and support as they take cholestyramine before their surgery, and they will help researchers understand how well this treatment works in reducing POPs in their blood.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).