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Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese Patients.

Study acronym: VITADOSE
StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 27, 2023 (before its estimated September 13, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since May 2023); last known: Recruiting
  2. Notable Start date: Dec 8, 2016 to Mar 17, 2017v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jan 2018 to Sep 13, 2025 · Completion date: Jan 2019 to Sep 13, 2026 · Start date: Jan 2017 to Dec 8, 2016 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Jan 2018 to Sep 13, 2025
    • Completion date: Jan 2019 to Sep 13, 2026
    • Start date: Jan 2017 to Dec 8, 2016
    • Site details revised
  4. Minor Start date: Dec 2016 to Jan 2017 Interventions: blood samples analysis (Biological), subcutaneous and visceral adipose tissue biopsie (Biological) to blood samples analysis (Biological), subcutaneous and visceral adipose tissue biopsies (Biological) · Eligibility criteria expanded, about 1 wordv2 Show 2 more changesShow less
    • Interventions: blood samples analysis (Biological), subcutaneous and visceral adipose tissue biopsie (Biological) to blood samples analysis (Biological), subcutaneous and visceral adipose tissue biopsies (Biological)
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Vitamin D (VD) is a pleiotropic hormone, involved in many physiological processes including calcium and phosphorus absorption. The VD metabolism begin to be well-known and involves a hepatic hydroxylation (mediated by enzymes, which belong to the cytochrome P450 family) leading to the production of the 25(OH)D, which corresponds to the circulating form of the VD. After circulation in blood, the 25(OH)D is submitted to a second hydroxylation in the kidney resulting to the generation of 1,25(OH)2D, the active metabolite of VD. Numerous epidemiological studies reported an inverse relationship between obesity and circulation level of 25(OH)D. Several mechanisms could explain the low level of 25(OH)D observed in obese subjects, the more classical evoked being based on sequestration and/or dilution of VD in adipose tissue (AT), the main VD storage site. However, this mechanism has never been demonstrated. In order to confirm this hypothesis, the concentration of VD and its metabolites in adipose tissue need to be quantified. The objective of this study is to determine the concentration of VD and its metabolites in adipose tissue as well as adipose tissue mass quantification and distribution (visceral or subcutaneous) to highlight putative difference of VD and its metabolites quantities between obese and non-obese patients. A quantification of VD metabolism, inflammation and lipid metabolism gene expression will be realized on biopsies. Correlations between gene expression and quantity of VD in tissue will be carrying out.
Trial Details
NCT Number NCT03008525
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Obesity; Endocrine
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov