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Exploratory evaluation of the effect of cholestyramine on serum levels of persistent organic pollutants in obese patients

Phase 1
Conditions
Obesity
MedDRA version: 20.0Level: PTClassification code: 10014989Term: Epidermolysis bullosa Class: 100000004850
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Registration Number
CTIS2023-505116-37-00
Lead Sponsor
Centre Hospitalier Universitaire De Nice
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
20
Inclusion Criteria

Female patients with an accepted indication for bariatric surgery (BMI > 40 kg/m2 or BMI > 35 kg/m2 with complication(s) improveable by surgery), Aged between 18 and 45 years, Having effective contraception (oral contraception, hormonal or non-hormonal intrauterine device, progestin implant) which will be adapted in the peri-operative period in accordance with the recommendations in force

Exclusion Criteria

Pregnant or breastfeeding women, Known allergy or intolerance to cholestyramine, Chronic constipation, Chronic disease that may interfere with the efficacy of treatment (unbalanced diabetes with HbA1c >7%, known and treated dyslipidaemia, chronic renal failure with GFR <60 ml/min, hepatocellular failure), Phenylketonuria, Patients on anti-vitamin K, digoxin, levothyroxine or likely to be on such therapy within 3 months of inclusion.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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