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

This study is currently recruiting participants.
Verified August 2011 by Assistance Publique - Hôpitaux de Paris
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
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Drug: phenotypical approach
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: September 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phenotypical approach
phenotypical approach
 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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443039

Contacts
Contact: Célia LLORET-LINARES, MD 00 33 149958309 celialloret@yahoo.fr

Locations
France
Unit of internal medicine A, Lariboisière Hospital Recruiting
Paris, France, 75010
Contact: Célia LLORET-LINARES, MD     00 33 149958309     celialloret@yahoo.fr    
Principal Investigator: Célia LLORET-LINARES, MD            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Célia LLORET-LINARES, MD, Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01443039     History of Changes
Other Study ID Numbers: P100506, 2011-A00312-39
Study First Received: August 19, 2011
Last Updated: October 6, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
drug metabolizing enzymes and drug transporter
Roux-en Y-Gastric Bypass
Obesity
Drug Availability
BMI over 35kg/m² and comorbidities or >40kg/m²

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013