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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 1

Conditions

Obesity

Treatments

Drug: phenotypical approach

Study type

Interventional

Funder types

Other

Identifiers

NCT01443039

P100506

2011-A00312-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 polymorphisms known to affect expression and/or activity of enzymes and transporter.
Intestinal and hepatic expression and activity of the enzymes and transporter of interest.
Markers of inflammation Methodology, study design : open-labelled monocentric study.

Sample size : It will be a descriptive experimental study involving 12 subjects.

Study design : In centre 1: Inclusion at least 2 weeks prior to surgery (V0)

In centre 2: Three studies of 12 hours each will occur (in addition with the usual clinical and surgical follow up) at three times periods: in the 8 weeks period before surgery (V1), at 5-8 weeks after surgery (V2) and at 25-30 weeks after surgery (V3).

In centre 3: the patients will undergo gastric bypass surgery (corresponding to the usual clinical and surgical follow up) and samples of jejunum and liver will be obtain during the surgery (J0).

Centres 4 and 5 are involved in samples analysis.Hence, patients will attend 3 visits, in addition to the usual clinical and surgical follow-up.

Study duration: 26 months (with duration of inclusion of 18 months)

Duration for a patient: 38 weeks at maximum (8 months)

Investigating center and participating units: one center enrolling the patients and three centers involving in the others investigations.

Enrollment

11 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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