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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00943969
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):
Célia LLORET LINARES, Hopital Lariboisière

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: gastric bypass Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass
Study Start Date : April 2009
Primary Completion Date : May 2009
Study Completion Date : January 2010

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U.S. FDA Resources

Arm Intervention/treatment
obemo Procedure: gastric bypass
gastric bypass combines restrictive and malabsorptive procedures

Primary Outcome Measures :
  1. 30mg Oral morphine systemic exposure (AUC 0-24) [ Time Frame: Before surgery-7-15 days after surgery- 6 months after surgery ]

Secondary Outcome Measures :
  1. Morphine and M6G AUC, clearance, Cmax and Tmax [ Time Frame: Before surgery-7-15 days after surgery- 6 months after surgery ]
  2. fat mass and total body water (assessed by DEXA and BIA) [ Time Frame: before surgery and 6 months following surgery ]
  3. mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies [ Time Frame: obtained from the bariatric surgery ]
  4. 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 ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00943969

Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital
Paris cedex 10, France, 75475
Sponsors and Collaborators
Hopital Lariboisière
Principal Investigator: Célia LLoret Linares Assistance Publique - Hôpitaux de Paris

Responsible Party: Célia LLORET LINARES, MCU-PH, Hopital Lariboisière Identifier: NCT00943969     History of Changes
Other Study ID Numbers: CPP 0911965
First Posted: July 22, 2009    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Keywords provided by Célia LLORET LINARES, Hopital Lariboisière:
gastric bypass

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents