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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01443039
First received: August 19, 2011
Last updated: October 6, 2011
Last verified: August 2011

August 19, 2011
October 6, 2011
September 2011
January 2014   (final data collection date for primary outcome measure)
  • Phenotypical markers of enzymes and transporter activity [ Time Frame: at 5-8weeks ] [ Designated as safety issue: No ]
    plasmatic [Paraxanthine/cafeine] ratio (T4H) at 5-8 weeks following surgery. - plasmatic [Omeprazole/5-hydroxyomeprazole] ratio (T4H) at 5-8 weeks following surgery. - urinary Log (dextromethorphan/dextrorphan) (T0-T8h) at 5-8 weeks following surgery. - urinary Losartan/ E-3174 (T0-8h) at 5-8 weeks following surgery. - plasmatic AUC 0-inf midazolam at 5-8 weeks following surgery. - plasmatic AUC 0-inf digoxin at 5-8 weeks following surgery
  • Phenotypical markers of enzymes and transporter activity [ Time Frame: 25-30 weeks ] [ Designated as safety issue: No ]
    plasmatic [Paraxanthine/cafeine] ratio (T4H) at 25-30 weeks following surgery. - plasmatic [Omeprazole/5-hydroxyomeprazole] ratio (T4H) at 25-30 weeks following surgery. - urinary Log (dextromethorphan/dextrorphan) (T0-T8h) at 25-30 weeks following surgery. - urinary Losartan/ E-3174 (T0-8h) at 25-30 weeks following surgery. - plasmatic AUC 0-inf midazolam at 25-30 weeks following surgery. - plasmatic AUC 0-inf digoxin at 25-30 weeks following surgery
Same as current
Complete list of historical versions of study NCT01443039 on ClinicalTrials.gov Archive Site
Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation [ Time Frame: before surgery ] [ Designated as safety issue: No ]
Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation
Same as current
Not Provided
Not Provided
 
Phenotypical Approach of the Drug Metabolizing Hormones Activity Before and After Roux-en Y-Gastric Bypass
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Drug: 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
Experimental: phenotypical approach
phenotypical approach
Intervention: Drug: phenotypical approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
January 2014
January 2014   (final data collection date for primary outcome measure)

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 non smoking and without contraception with estrogens compounds and without any medication 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
Both
18 Years to 60 Years
No
Contact: Célia LLORET-LINARES, MD 00 33 149958309 celialloret@yahoo.fr
France
 
NCT01443039
P100506, 2011-A00312-39
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Principal Investigator: Célia LLORET-LINARES, MD, Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP