NCT03008525 Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese Patients.
| NCT ID | NCT03008525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Obesity; Endocrine |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2017-03-17 |
| Primary Completion | 2025-09-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2017-03-17 with a primary completion date of 2025-09-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Urielle Desalbres
STUDY DIRECTOR
Assistance Publique Hôpitaux de Marseille
Frequently Asked Questions
Who can join the NCT03008525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity; Endocrine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03008525 currently recruiting?
Yes, NCT03008525 is actively recruiting participants. Contact the research team at rene.valero@ap-hm.fr for enrollment information.
Where is the NCT03008525 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT03008525 clinical trial?
NCT03008525 is sponsored by Assistance Publique Hopitaux De Marseille. The principal investigator is Urielle Desalbres at Assistance Publique Hôpitaux de Marseille. The trial plans to enroll 60 participants.
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