ObesityPhase 1SODANCT01443039
Phenotypical Approach of the Drug Metabolizing Hormones Activity Before and After Roux-en Y-Gastric Bypass
A Phase 1 study testing phenotypical approach in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- phenotypical approach
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Tabacco
- Contraception including estrogens compounds
- Medication other than vitamins.
- Allergy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- phenotypical approach
- Keywords
- drug metabolizing enzymes and drug transporter, Roux-en Y-Gastric Bypass, Obesity, Drug Availability, BMI over 35kg/m² and comorbidities or >40kg/m²
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| phenotypical approach | Experimental | phenotypical approach Receives: Drug: phenotypical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 25-30 weeks
Secondary outcomes (1)
Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation
Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Célia LLORET-LINARES, MD,, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443039
- Sponsor's protocol ID
- P100506
- Other IDs
- 2011-A00312-39
- Acronym
- SODA
- Status last verified
- Dec 2016
- First submitted
- 19 Aug 2011
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01443039
- Acronym / sponsor ID
- SODA / P100506
- Conditions
- Obesity
- Keywords
- drug metabolizing enzymes and drug transporter, Roux-en Y-Gastric Bypass, Obesity, Drug Availability, BMI over 35kg/m² and comorbidities or >40kg/m²
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| phenotypical approach | Experimental | Drug: phenotypical approachphenotypical approach |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- Tabacco
- Contraception including estrogens compounds
- Medication other than vitamins.
- Allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenotypical approacheach 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 | Drug | phenotypical approach |
Primary outcome
Phenotypical markers of enzymes and transporter activity
Time frame: at 5-8weeks
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
Phenotypical markers of enzymes and transporter activity
Time frame: 25-30 weeks
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
1 secondary outcome
Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation
Time frame: before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Célia LLORET-LINARES, MD, principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing phenotypical approach in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypical markers of enzymes and transporter activity (time frame: at 5-8weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.