NCT03202706

Brief Summary

Obesity is associated with hyperactivation of the endocannabinoid system, and its inhibition by the administration of CB1 receptor (CB1R) antagonists, leads to a decrease in food intake, weight loss and an improvement in metabolic parameters. Even though the reduction in food intake following central CB1R inactivation seems to be the principal cause of weight loss and the improvement in metabolic parameters, several studies in animals and humans have indicated that peripheral CB1R could also be implicated in the regulation of glucolipid metabolism. As a result, it has been suggested that the long-term beneficial effects of inactivation of the endocannabinoid system are due to both central effects on food intake and peripheral effects involving adipose tissue, the liver, skeletal muscle and the pancreas. It appears essential to determine the role of CB1R located in peripheral tissues and in particular in adipose tissue, which plays an active role in maintaining glucolipid homeostasis. The experiments conducted in this project consist in studying in biopsies of abdominal subcutaneous fat whether activation of adipocyte CB1R modifies adipocyte metabolism by determining the mechanisms. The investigators hypothesize that activation of CB1R in adipose tissue will lead to the stimulation of lipolysis dependent on the alteration of the insulin signal, and therefore that inactivation of the endocannabinoid system by blocking peripheral CB1R could constitute a therapeutic approach to improve obesity-related insulin resistance and dyslipidaemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

3.9 years

First QC Date

June 21, 2017

Last Update Submit

February 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glucolipid metabolism analysis in human abdominal subcutaneous and visceral fat

    Baseline

Study Arms (1)

Patients

Procedure: Samples of adipose tissue

Interventions

Samples of visceral and subcutaneous adipose tissue collected during hernia surgery

Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing surgery for hernia

You may qualify if:

  • men aged 18 to 70 years
  • persons who have provided oral consent
  • persons undergoing surgery for hernia

You may not qualify if:

  • persons without health insurance cover
  • BMI \> 30
  • diabetes
  • associated diseases: cancer, chronic inflammatory diseases
  • adults under guardianship
  • obese subjects
  • men aged 18 to 70 years
  • BMI \> 30
  • persons who have provided oral consent
  • persons undergoing surgery for hernia
  • persons without health insurance cover
  • diabetes
  • associated diseases: cancer, chronic inflammatory diseases
  • adults under guardianship
  • diabetic obese subjects
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 28, 2017

Study Start

February 24, 2016

Primary Completion

January 7, 2020

Study Completion

January 7, 2020

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations