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NCT Number: NCT03008525

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13005, France

Location status: Recruiting

Location contact

Rene VALERO

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject with a BMI greater than 35 kg / m2 (group OB) or less than 30 kg / m² (group NO)
  • Subject undergoing bariatric surgery (OB group) or abdominal surgery (group NO)

Exclusion criteria

  • Regular intake of dietary supplements or vitamin supplements in the last three months
  • For the subjects of the group NO:
  • Malnourished patient (BMI <18.5 kg / m2, weight loss greater than 5% in 1 month or 10% in 6 months)
  • Subject with an infection or inflammatory syndrome (CRP> 10 mg / L and / or white blood cells> 12000 / mm3)
  • Non-cancerous subject

Treatment and study plan

subcutaneous and visceral adipose tissue biopsies

Biological

Subcutaneous and visceral adipose tissue biopsies during operation

blood samples analysis

Biological

Blood sampling is required to measure plasma cholecalciferol, calcidiol and calcitriol concentrations, as well as biological parameters of interest.

Another plasma/serum tube is used to measure pro- and anti-inflammatory cytokines and adiponectin.

Primary outcomes

  1. quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Rene VALERO

CONTACT

[email protected]

0491383393 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: VITADOSE

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Jan 2, 2017
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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