Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass (OBEMO)

December 14, 2015 updated by: Célia LLORET LINARES, Hopital Lariboisière
The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris cedex 10, France, 75475
        • Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged between 18 and 60 years old.
  • Patients with morbid obesity (IMC > 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension or steatosis hepatitis) with a favourable decision of a multidisciplinary team for a gastric bypass.
  • Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.
  • Patient with a previous medical examination.
  • Patient giving its well-informed and free consent after information.

Exclusion Criteria:

  • diabetes
  • concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine
  • untreated sleep apnea syndrom, hypoxia (PaO2<70mmHg) or hypercapnia (PaCO2>45mmHg), anaemia <10g/dL, ASAT or ALAT>3N

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: obemo
Procedure: gastric bypass
gastric bypass combines restrictive and malabsorptive procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
30mg Oral morphine systemic exposure (AUC 0-24)
Time Frame: Before surgery-7-15 days after surgery- 6 months after surgery
Before surgery-7-15 days after surgery- 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Morphine and M6G AUC, clearance, Cmax and Tmax
Time Frame: Before surgery-7-15 days after surgery- 6 months after surgery
Before surgery-7-15 days after surgery- 6 months after surgery
fat mass and total body water (assessed by DEXA and BIA)
Time Frame: before surgery and 6 months following surgery
before surgery and 6 months following surgery
mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies
Time Frame: obtained from the bariatric surgery
obtained from the bariatric surgery
genetic polymorphisms known to affect expression and/or activity of enzymes, receptors and transporters involved in morphine PK/PD (UGT2B7, P-gp, OPRM1, COMT) and morphine PK/PD
Time Frame: Before surgery
Before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Lariboisière

Investigators

  • Principal Investigator: Célia LLoret Linares, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (Estimate)

July 22, 2009

Study Record Updates

Last Update Posted (Estimate)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPP 0911965

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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