Phenotypical Approach of the Drug Metabolizing Hormones Activity Before and After Roux-en Y-Gastric Bypass

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric Bypass.

Primary aim : To study the intra individual evolution of phenotypical markers of different drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Ministry of Health, France
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Patients with morbid obesity (IMC > 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension without treatment or steatosis hepatitis) candidates for a gastric bypass.

• Patient not receiving more than two treatments whose effect on the expression of enzymes and drug transporters is zero other than vitamins.

• Patient agreeing to participate at three studies of one day (12 hours) occurring at three different periods.

• Patients aged between 18 and 60 years old.

• Patient giving its well-informed and free consent.

• Patient without allergy to any of the drugs used for test.

• Patients living in France during the study and with French social security

Exclusion Criteria:

• Tabacco

• Contraception including estrogens compounds

• Medication other than vitamins.

• Allergy