NCT01443039

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 metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

January 4, 2017

Status Verified

December 1, 2016

Enrollment Period

2.4 years

First QC Date

August 19, 2011

Last Update Submit

January 3, 2017

Conditions

Obesity

Keywords

drug metabolizing enzymes and drug transporterRoux-en Y-Gastric BypassObesityDrug AvailabilityBMI over 35kg/m² and comorbidities or >40kg/m²

Outcome Measures

Primary Outcomes (2)

  • Phenotypical markers of enzymes and transporter activity

    plasmatic \[Paraxanthine/caffeine\] 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

    at 5-8weeks

  • Phenotypical markers of enzymes and transporter activity

    plasmatic \[Paraxanthine/caffeine\] 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

    25-30 weeks

Secondary Outcomes (1)

  • Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation

    before surgery

Study Arms (1)

phenotypical approach

EXPERIMENTAL

phenotypical approach

Drug: phenotypical approach

Interventions

phenotypical approachDRUG

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

phenotypical approach

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Tabacco
  • Contraception including estrogens compounds
  • Medication other than vitamins.
  • Allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unit of internal medicine A, Lariboisière Hospital

Paris, 75010, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Célia LLORET-LINARES, MD,

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2011

First Posted

September 29, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

January 4, 2017

Record last verified: 2016-12

Locations

FR(1)