Clinical Trial

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

Study acronym: VITADOSE
Recruiting
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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.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2016-12-29; most recent amendment 2023-07-25.
Status change: Not Yet Recruiting → Recruiting 2023-05-11
Trial Details
NCT Number NCT03008525
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Obesity; Endocrine
Enrollment 60 participants
Start Date 2017-03-17
Primary Completion 2025-09-13 (estimated)
Study Completion 2026-09-13 (estimated)
Updated on ClinicalTrials.gov 2023-07-27