NCT04940962 Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion
| NCT ID | NCT04940962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Dijon |
| Condition | Diabete Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2021-09-29 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2021-09-29 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. clarify whether obesity, associated or not with diabetes, leads to an overproduction of ECs (specifying which ones) by visceral or subcutaneous adipose tissue 2. 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04940962 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Diabete Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04940962 currently recruiting?
Yes, NCT04940962 is actively recruiting participants. Contact the research team at pablo.ortega-deballon@chu-dijon.fr for enrollment information.
Where is the NCT04940962 trial being conducted?
This trial is being conducted at Dijon, France.
Who is sponsoring the NCT04940962 clinical trial?
NCT04940962 is sponsored by Centre Hospitalier Universitaire Dijon. The trial plans to enroll 45 participants.