Translational Study Using Human Abdominal Adipose Tissue... | NCT04940962

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2021Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Sep 2027Estimated

First Submitted Date

May 10, 2021

First Submission Date that Met QC Criteria

Jun 18, 2021

First Posted Date

Jun 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2025

Last Update Posted Date

Jul 28, 2025Actual

Description Module

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:

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

This study will also provide an opportunity to evaluate the production of adipokines and cytokines involved in the control of energy homeostasis under the different experimental conditions.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sampling of adipose tissue	Procedure	Removal of less than 1 cm3 of adipose tissue during visceral surgery	Diabetic obese Non-diabetic obese Witnesses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
digestive cancer with recent weight loss (≥10%) and/or malnutrition
known metastatic cancer
cancer undergoing long-term hormonal treatment
protected adult

Obese diabetic subjects:

Person not covered by national health insurance
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
type 1 diabetes
secondary diabetes
protected adult

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003924	Diabetes Mellitus, Type 2
D056128	Obesity, Abdominal

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms