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

Obesity; Endocrine Clinical Trial

— VITADOSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03008525
• Other study ID #: 2016-23
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: September 13, 2026

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Rene VALERO
• Phone: 0491383393
• Email: rene.valero[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 13, 2026
• Est. primary completion date: September 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity; Endocrine

Intervention

Biological:
• subcutaneous and visceral adipose tissue biopsies
Subcutaneous and visceral adipose tissue biopsies during operation
• blood samples analysis
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.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies		12 months