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ObesityCCENDONCT01003873

Gastric Bypass and Peripheral Activity of the Endocannabinoid System

An observational study of Obesity, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Evaluation of the endocannabinoid system, Biopsy of visceral and peripheral adipose tissue and Evaluation of metabolic parameters
How many people
44 participants
Where
1 siteFrance
Study dates
Oct 2009to Jun 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: 2 groups : from primary care clinic * obese patients with gastric bypass * obese patients with lifestyle intervention 1 group : volunteer

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Haut Lévêque Hospital, Endocrine department

    Pessac, 33600

Other trials in France

About this study

Official title: Effect of Weight Loss Induced Either by Gastric Bypass or Lifestyle Intervention on the 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

Read the detailed description

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
Conditions
Obesity
Being tested
Evaluation of the endocannabinoid system, Biopsy of visceral and peripheral adipose tissue, Evaluation of metabolic parameters, Evolution of behavioral parameters, Dietician consultation
Keywords
morbid obesity, bariatric surgery, lifestyle intervention, endocannabinoids system
Medical subject headings
Obesity, Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of the endocannabinoid systemBiological

    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 tissueProcedure or surgery

    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 parametersBiological

    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 parametersBehavioural

    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 consultationBehavioural

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

  • Psychologist consultationBehavioural

    The behavioural evaluation will de done with a psychologist consultation

Study groups in NCT01003873
Study groupRoleWhat they receive
Bypass gastricFirst arm is represented by obese patients that will be studied before and after a gastric bypass. They will be studied before surgery as well as 1 month and 6 months after surgery.
Receives: Biological: Evaluation of the endocannabinoid system; Procedure: Biopsy of visceral and peripheral adipose tissue; Biological: Evaluation of metabolic parameters; Behavioral: Evolution of behavioral parameters; Behavioral: Dietician consultation; Behavioral: Psychologist consultation
Lifestyle interventionThe second group is represented by obese patients that will be studied before lifestyle intervention, 6 months after the beginning of the intervention and after a time that will allow patients to lose the same amount of weight that patients that had been through surgery had lost one month after surgery.
Receives: Biological: Evaluation of the endocannabinoid system; Biological: Evaluation of metabolic parameters; Behavioral: Evolution of behavioral parameters; Behavioral: Dietician consultation; Behavioral: Psychologist consultation
Control subjectsThe third group is a control group of normal weight people that will be studied at one time and after 6 months with stable weight.
Receives: Biological: Evaluation of the endocannabinoid system; Biological: Evaluation of metabolic parameters; Behavioral: Evolution of behavioral parameters

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasmatic endocannabinoïd concentration variation

    Measured: Inclusion and 6 month-follow up

Secondary outcomes (9)

  1. Plasma concentration of the endocannabinoids during food exposure

    Measured: At each visit

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

    Measured: At each visit

  3. Adipose tissue concentration of the endocannabinoids

    Measured: Inclusion and 6 month-follow up

  4. Plasma concentration of adipokines

    Measured: At each visit

  5. Body mass index

    Measured: At each visit

  6. Body composition

    Measured: At each visit

  7. Insulin sensitivity

    Measured: At each visit

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

    Measured: Inclusion and 6 month follow-up

  9. Questionaries scores

    Measured: At each visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01003873
Sponsor's protocol ID
CHUBX 2008/19
Acronym
CCENDO
Status last verified
Oct 2018
First submitted
27 Oct 2009
Last updated
16 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Di Marzo V, Matias I. Endocannabinoid control of food intake and energy balance. Nat Neurosci. 2005 May;8(5):585-9. doi: 10.1038/nn1457.

    PubMed 15856067

  • Cota D. CB1 receptors: emerging evidence for central and peripheral mechanisms that regulate energy balance, metabolism, and cardiovascular health. Diabetes Metab Res Rev. 2007 Oct;23(7):507-17. doi: 10.1002/dmrr.764.

    PubMed 17683024

  • Engeli S, Bohnke J, Feldpausch M, Gorzelniak K, Janke J, Batkai S, Pacher P, Harvey-White J, Luft FC, Sharma AM, Jordan J. Activation of the peripheral endocannabinoid system in human obesity. Diabetes. 2005 Oct;54(10):2838-43. doi: 10.2337/diabetes.54.10.2838.

    PubMed 16186383

  • Bluher M, Engeli S, Kloting N, Berndt J, Fasshauer M, Batkai S, Pacher P, Schon MR, Jordan J, Stumvoll M. Dysregulation of the peripheral and adipose tissue endocannabinoid system in human abdominal obesity. Diabetes. 2006 Nov;55(11):3053-60. doi: 10.2337/db06-0812.

    PubMed 17065342

  • Sjostrom L, Narbro K, Sjostrom CD, Karason K, Larsson B, Wedel H, Lystig T, Sullivan M, Bouchard C, Carlsson B, Bengtsson C, Dahlgren S, Gummesson A, Jacobson P, Karlsson J, Lindroos AK, Lonroth H, Naslund I, Olbers T, Stenlof K, Torgerson J, Agren G, Carlsson LM; Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007 Aug 23;357(8):741-52. doi: 10.1056/NEJMoa066254.

    PubMed 17715408

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasmatic endocannabinoïd concentration variation (time frame: Inclusion and 6 month-follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01003873, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.

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