Status:
COMPLETED
Phenotypical Approach of the Drug Metabolizing Hormones Activity Before and After Roux-en Y-Gastric Bypass
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 met...
Detailed Description
Principal Judgement criteria : Phenotypical markers of enzymes and transporter activity before, at 5-8 weeks and 25-30 weeks following surgery. Secondary judgement criteria : * Genetic polymorphism...
Eligibility Criteria
Inclusion
- 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
- Tabacco
- Contraception including estrogens compounds
- Medication other than vitamins.
- Allergy
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01443039
Start Date
September 1 2011
End Date
February 1 2014
Last Update
January 4 2017
Active Locations (1)
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1
Unit of internal medicine A, Lariboisière Hospital
Paris, France, 75010