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

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Unknown status
CT.gov ID
NCT03008525
Collaborator
(none)
60
1
2
24
2.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: subcutaneous and visceral adipose tissue biopsies
  • Biological: blood samples analysis
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: obese patients (group OB)

patients with body mass index ≥ 35 kg/m²

Biological: subcutaneous and visceral adipose tissue biopsies

Biological: blood samples analysis

Active Comparator: non-obese patients (group NO)

patients with body mass index < 30 kg/m²

Biological: subcutaneous and visceral adipose tissue biopsies

Biological: blood samples analysis

Outcome Measures

Primary Outcome Measures

  1. quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assistance Publique Hôpitaux de Marseille Marseille France 13005

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Urielle Desalbres, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT03008525
Other Study ID Numbers:
  • 2016-23
First Posted:
Jan 2, 2017
Last Update Posted:
Jan 10, 2017
Last Verified:
Dec 1, 2016

Study Results

No Results Posted as of Jan 10, 2017