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Completed

NCT Number: NCT00943969

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Paris, 75475, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric bypass

Procedure

gastric bypass combines restrictive and malabsorptive procedures

Primary outcomes

  1. 30mg Oral morphine systemic exposure (AUC 0-24)

    Time frame: Before surgery-7-15 days after surgery- 6 months after surgery

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hopital Lariboisière

Other

Registry information

Acronym: OBEMO

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 22, 2009
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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