Diabete Type 2ENDOCATANCT04940962
Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion
A study testing Sampling of adipose tissue in people with Diabete Type 2 and Abdominal Obesity, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabete Type 2, Abdominal Obesity
- What is being tested?
- Sampling of adipose tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2021to 19 May 2026
- Phase
- Interventional
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Controls:
- Person not covered by national health insurance.
- BMI > 30
- diabetes
- chronic inflammatory disease
- cancer undergoing chemotherapy or chemotherapy less than a year old
Show all 29Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Diabete Type 2, Abdominal Obesity
- Being tested
- Sampling of adipose tissue
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of adipose tissueProcedure or surgery
Removal of less than 1 cm3 of adipose tissue during visceral surgery
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic obese | Experimental | Not described Receives: Procedure: Sampling of adipose tissue |
| Diabetic obese | Experimental | Not described Receives: Procedure: Sampling of adipose tissue |
| Witnesses | Active comparator | Not described Receives: Procedure: Sampling of adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start29 Sep 2021
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940962
- Sponsor's protocol ID
- VERGES 2020
- Acronym
- ENDOCATA
- Status last verified
- Sep 2026
- First submitted
- 10 May 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion
- ClinicalTrials.gov ID
- NCT04940962
- Acronym / sponsor ID
- ENDOCATA / VERGES 2020
- Conditions
- Diabete Type 2, Abdominal Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Controls:
- men or post-menopausal women aged between 18 and 80
- gave oral consent
- to undergo visceral surgery
- men or post-menopausal women aged between 18 and 80
Key exclusion criteria (29 listed)
- Controls:
- Person not covered by national health insurance.
- BMI > 30
- diabetes
- chronic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sampling of adipose tissueRemoval of less than 1 cm3 of adipose tissue during visceral surgery | Procedure or surgery | Diabetic obese, Non-diabetic obese, Witnesses |
Primary outcome
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.
Time frame: 12 hours
The assay will be performed using a technique of liquide chromatography coupled to a mass spectrometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling of adipose tissue in people with Diabete Type 2 and Abdominal Obesity, run by Centre Hospitalier Universitaire Dijon 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 15 inclusion and 29 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 21 Sep 2026. 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?
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. (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.