Overview

This trial is active, not recruiting.

Condition obesity
Treatment phenotypical approach
Phase phase 1
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator Ministry of Health, France
Start date September 2011
End date January 2015
Trial size 10 participants
Trial identifier NCT01443039, 2011-A00312-39, P100506

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
phenotypical approach
phenotypical approach
each visit : CAFEINE : (solution orale) 2 ampoules de 2 ml = 100 mg de CAFEINE DEXTROMETHORPHANE : 15 ml de sirop contains 20 mg =>22,5 ml = 30mg Midazolam : (solution injectable, ampoule 1 ml = 1 mg) : deux ampoules = 2 mg Digoxine nativelle (solution injectable, ampoule de 0.5mg) : 1 ampoule per os = 0.5 mg Losartan 50 mg : 1cp de 50mg

Primary Outcomes

Measure
Phenotypical markers of enzymes and transporter activity
time frame: at 5-8weeks
Phenotypical markers of enzymes and transporter activity
time frame: 25-30 weeks

Secondary Outcomes

Measure
Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation
time frame: before surgery

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Phenotypical Approach of the Drug Metabolizing Hormones Activity (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp) Before and After Roux-en Y-Gastric Bypass. The SODA Protocol: Surgery for Obesity and Drug Availability
Principal investigator Célia LLORET-LINARES, MD,
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.