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Translational Study Using Human Abdominal Adipose Tissue Biopsies to Investigate the Role of Cannabinoid Receptor 1 (CB1) in Controlling Endocannabinoid and Adipokine Secretion

Study acronym: ENDOCATA
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Final enrollment: 53 participants (planned 45) · Primary completion date changed from estimate of Sep 2027 to May 19, 2026 · Eligibility criteria expanded, about 40 words · 1 more Show 4 more changesShow less
    • Final enrollment: 53 participants (planned 45)
    • Primary completion date changed from estimate of Sep 2027 to May 19, 2026
    • Eligibility criteria expanded, about 40 words
    • Site details revised
  2. Notable Primary and study completion dates: Sep 2025 to Sep 2027v4
  3. Notable Primary and study completion dates: Sep 2023 to Sep 2025 Eligibility criteria expanded, about 78 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 78 words

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2021 to Sep 29, 2021 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Sep 2021 to Sep 29, 2021
    • Site details revised
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04940962
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Diabete Type 2, Abdominal Obesity
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov