NCT01223157

Brief Summary

Up till now, the evaluation of the endocannabinoid system (ECS) in humans needs invasive procedures. The investigators managed in the lab to determine the levels of endocannabinoids in a small number of subjects. The aim of the study is to confirm that salivary is a useful tool to evaluate the activity of the ECS both in normal weight and obese subjects that are characterised by a hyperactivity of the system. Therefore, the first objective of the study is to compare the fasting level of salivary anandamide between 12 obese patients and 12 normal weight subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
Last Updated

April 28, 2011

Status Verified

April 1, 2011

Enrollment Period

Same day

First QC Date

October 15, 2010

Last Update Submit

April 27, 2011

Conditions

Obesity

Keywords

obesityendocannabinoids

Outcome Measures

Primary Outcomes (1)

  • Anandamide(AEA)concentration

    The primary outcome will be the difference of fasting saliva anandamide (AEA) concentration between obese and normal weight subjects.

    Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch

Secondary Outcomes (5)

  • 2-AG( 2 arachidonoylglycerol), OEA (oleoylethanolamide), PEA (palmitoyléthanolamide) concentrations

    Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch

  • Food intake influence on saliva endocannabinoids

    Saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch

  • Plasma endocannabinoids level

    Blood sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch

  • Correlation between saliva and plasma endocannabinoids

    Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch

  • Relationship between saliva or plasma endocannabinoids and gut hormones

    Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch

Study Arms (2)

Obese patients

EXPERIMENTAL
Biological: Biological data

Normal weight subjects

EXPERIMENTAL
Biological: Biological data

Interventions

Biological dataBIOLOGICAL

Height, Weight, waist circumference and systolic and diastolic blood pressure will be measured in obese and normal subjects. Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch. This will allow a measurement of fasting glycaemia and insulin, fasting cholesterol and triglycerides, liver profile. Endocannabinoids will be measured both in plasma and saliva at each time point. Gut hormones (Ghrelin and PYY) will be measured before, just before and after lunch in plasma.

Normal weight subjectsObese patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese patients :
  • Age between 18 and 65 yrs
  • BMI (Body Mass Index) \> 30 kg/m²
  • Signed inform Consent before any investigation related to the study
  • No smoker
  • Normal weight subjects :
  • Age between 18 and 65 yrs
  • BMI between 18 and 25 kg/m²
  • Signed inform Consent before any investigation related to the study
  • No smoker

You may not qualify if:

  • treatments that could interfere with the endocannabinoid system (anxiolytics, anticonvulsivants, antidepressants drugs)
  • pregnancy, breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service of Endocrinology, Diabetology, metabolic diseases - Hôpital du Haut Lévêque - CHU de BORDEAUX

Bordeaux, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Blandine GATTA, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2010

First Posted

October 18, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

April 28, 2011

Record last verified: 2011-04

Locations

FR(1)