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

NCT00943969 | Completed Phase 4

• 1 other identifier: CPP 0911965
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; gastric bypass; morphine; pharmacokinetic; absorption

Outcome Measures

Primary Outcomes (1)

• 30mg Oral morphine systemic exposure (AUC 0-24)

  Before surgery-7-15 days after surgery- 6 months after surgery

Secondary Outcomes (4)

• Morphine and M6G AUC, clearance, Cmax and Tmax

  Before surgery-7-15 days after surgery- 6 months after surgery

• fat mass and total body water (assessed by DEXA and BIA)

  before surgery and 6 months following surgery

• mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies

  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

  Before surgery

Study Arms (1)

obemo

OTHER

Procedure: gastric bypass

Interventions

gastric bypass PROCEDURE

gastric bypass combines restrictive and malabsorptive procedures

obemo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Lariboisière: lead

Study Sites (1)

Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital

Paris, 75475, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Célia LLoret Linares

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MCU-PH

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

FR (1)