NCT04940962

Brief Summary

Abdominal obesity and type 2 diabetes are associated with the hyperactivation of the endocannabinoid system. Several animal and human studies indicate that circulating endocannabinoid (EC) levels are correlated with body fat. Thus, adipose tissue, which possesses the enzymatic machinery for the synthesis of ECs, could be the main producer of plasma ECs. Today, it is clearly established that stimulation of the endocannabinoid system, via activation of cannabinoid receptor 1 (CB1s) located in the brain, leads to increased food intake and weight gain. Moreover, peripheral CB1s present in organs such as the liver, muscles and adipose tissue are involved in the establishment of metabolic deregulations linked to obesity (steatosis, insulin resistance, dyslipidemia). Thus, ECs produced by adipose tissue could play a key role in the regulation of carbohydrate-lipid homeostasis through their autocrine or paracrine actions by activating central and peripheral CB1s. Therefore, the objective of this study is to:

  1. 1.clarify whether obesity, associated or not with diabetes, leads to an overproduction of ECs (specifying which ones) by visceral or subcutaneous adipose tissue
  2. 2.to determine whether blocking CB1s with new peripherally acting antagonists can lead to a reduction in the production of ECs by adipose tissue.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Sep 2021Sep 2027

First Submitted

Initial submission to the registry

May 10, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

5.9 years

First QC Date

May 10, 2021

Last Update Submit

July 24, 2025

Conditions

Diabete Type 2Abdominal Obesity

Outcome Measures

Primary Outcomes (1)

  • Kinetics of the appearance of endocannabinoids produced by visceral adipose tissue explants in culture medium estimated by the area under the curve in obese subjects and in controls.

    The assay will be performed using a technique of liquide chromatography coupled to a mass spectrometer.

    12 hours

Study Arms (3)

Non-diabetic obese

EXPERIMENTAL
Procedure: Sampling of adipose tissue

Diabetic obese

EXPERIMENTAL
Procedure: Sampling of adipose tissue

Witnesses

ACTIVE COMPARATOR
Procedure: Sampling of adipose tissue

Interventions

Sampling of adipose tissuePROCEDURE

Removal of less than 1 cm3 of adipose tissue during visceral surgery

Diabetic obeseNon-diabetic obeseWitnesses

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Controls:
  • men or post-menopausal women aged between 18 and 80
  • gave oral consent
  • to undergo visceral surgery
  • Non-diabetic obese subjects:
  • men or post-menopausal women aged between 18 and 80
  • BMI \> 30
  • gave oral consent
  • to undergo visceral surgery
  • Obese diabetic subjects:
  • men or post-menopausal women aged between 18 and 80
  • type 2 diabetic not treated with Insulin or GLP-1 agonist
  • BMI \> 30
  • gave oral consent
  • to undergo visceral surgery

You may not qualify if:

  • Controls:
  • Person not covered by national health insurance.
  • BMI \> 30
  • diabetes
  • chronic inflammatory disease
  • cancer undergoing chemotherapy or chemotherapy less than a year old
  • digestive cancer with recent weight loss (≥10%) and/or malnutrition
  • known metastatic cancer
  • cancer undergoing long-term hormonal treatment
  • protected adult
  • Non-diabetic obese subjects:
  • Person not covered by national health insurance
  • diabetes
  • chronic inflammatory disease
  • cancer undergoing chemotherapy or chemotherapy less than a year old
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity, Abdominal

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Pablo ORTEGA DEBALLON

CONTACT

03.80.29.37.47pablo.ortega-deballon@chu-dijon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2021

First Posted

June 28, 2021

Study Start

September 29, 2021

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 28, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)