Skip to main content
OpenTrials
Completed

NCT Number: NCT01003873

Gastric Bypass and Peripheral Activity of the Endocannabinoid System

The aim of the study is to precise the effect of a large amount of weight loss induced by gastric bypass on the endocannabinoid system (plasma and adipose tissue) of morbidly obese patients and to determine the influence of a gastric bypass surgery compared to a lifestyle intervention with equivalent weight loss on the endocannabinoid system

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haut Lévêque Hospital, Endocrine department

Pessac, 33600, France

About this study

Dysregulation of the endocannabinoid system has been associated with the development of obesity, metabolic and cardiovascular disorders in both animals and humans.

Obese patients, especially those with abdominal obesity, have significantly higher levels of endocannabinoids. No influence of moderate (5%) body weight loss (induced either by diet intervention or sibutramine) on the peripheral activity of the endocannabinoid system gastric bypass (GB) surgery is the most efficient treatment of obesity Hormonal pathways may participate to the weight reducing effect of the procedure.The endocannabinoid system is present in the gastrointestinal tract.

In animals, sustained weight loss after GB is characterized by reduction of endocannabinoids levels.

The endocannabinoid levels will be studied (baseline and after stimulation) in:

  • Normal-weight subjects
  • Obese subjects before and after gastric bypass surgery
  • Obese subjects before and after a lifestyle intervention

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Arms 1 and 2:
  • Age between 18 and 60
  • BMI > 40kg/m² or at least 30kg/m² with complication
  • Medical follow up before surgery
  • Patients that engaged themselves to a long medical follow up
  • Efficient contraception
  • Written, informed consent of each subject before the beginning of the study
  • Arm 3:
  • Age between 18 and 60
  • BMI between 18 and 25 kg/m²
  • Stable weight over the 3 past months
  • Restrain score <4 disinhibition <6and hunger > 4 at the TFEQ
  • No job in the endocrinology department
  • Written, informed consent of each subject before the beginning of the study

Exclusion criteria

  • Arms 1,2 and 3
  • No care of obesity before inclusion
  • Incapacity of the patient to follow a medical follow up
  • Drug or alcohol abuse
  • Urine test result positive for THC
  • Threaten life diseases
  • Pregnancy, breast feeding
  • Smoking

Treatment and study plan

Evaluation of the endocannabinoid system

Biological

The evaluation of the endocannabinoid system consist in the determination of plasma concentration of the 2 main endocannabinoids (2AG and AEA) before (5 blood samples) and after (5 blood samples) after consumption of a calibrated food. As a comparator, ghrelin will be measured at the same time.

Biopsy of visceral and peripheral adipose tissue

Procedure

The endocannabinoids will be also determined in adipose tissue. Biopsy of visceral and peripheral adipose tissue will be done during surgery and peripheral adipose tissue will be done 6 months after surgery.

Evaluation of metabolic parameters

Biological

The evaluation of the metabolic status consist in evaluation of body composition (DEXA), determination of visceral adiposity (CT scan) and measurement of plasma lipids, glucose, insulin, leptin, adiponectin.

Evolution of behavioral parameters

Behavioral

The behavioral evaluation will de done with different questionnaires: ORWELL 97, HAD scale, Three Factor Eating Questionnaire, Beck Depression inventory, Questionnaire of personality TCI.

Dietician consultation

Behavioral

The evaluation of the metabolic status will also be seen by a dietician.

Psychologist consultation

Behavioral

The behavioural evaluation will de done with a psychologist consultation

Primary outcomes

  1. Plasmatic endocannabinoïd concentration variation

    Time frame: Inclusion and 6 month-follow up

Secondary outcomes

  1. Plasma concentration of the endocannabinoids during food exposure

    Time frame: At each visit

  2. Post prandial pic of the plasma concentration of the endocannabinoids

    Time frame: At each visit

  3. Adipose tissue concentration of the endocannabinoids

    Time frame: Inclusion and 6 month-follow up

  4. Plasma concentration of adipokines

    Time frame: At each visit

  5. Body mass index

    Time frame: At each visit

  6. Body composition

    Time frame: At each visit

  7. Insulin sensitivity

    Time frame: At each visit

  8. Area under the curve of plasma concentration of 2AG

    Time frame: Inclusion and 6 month follow-up

  9. Questionaries scores

    Time frame: At each visit

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

Effect of Weight Loss Induced Either by Gastric Bypass or Lifestyle Intervention on the Peripheral Activity of the Endocannabinoid System

Acronym: CCENDO

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2009
Registry last updated
Oct 16, 2018

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.

Published trials that share one or more normalized conditions with this study.