Obesity; EndocrineVITADOSENCT03008525
Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese Patients.
A study testing subcutaneous and visceral adipose tissue biopsies and blood samples analysis in people with Obesity; Endocrine, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity; Endocrine
- What is being tested?
- subcutaneous and visceral adipose tissue biopsies and blood samples analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2017to 13 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Rene VALERO, rene.valero@ap-hm.fr
About this study
Official title: Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese
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.
- Conditions
- Obesity; Endocrine
- Being tested
- subcutaneous and visceral adipose tissue biopsies, blood samples analysis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous and visceral adipose tissue biopsiesBiological
Subcutaneous and visceral adipose tissue biopsies during operation
blood samples analysisBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| obese patients (group OB) | Experimental | patients with body mass index ≥ 35 kg/m² Receives: Biological: subcutaneous and visceral adipose tissue biopsies; Biological: blood samples analysis |
| non-obese patients (group NO) | Active comparator | patients with body mass index < 30 kg/m² Receives: Biological: subcutaneous and visceral adipose tissue biopsies; Biological: blood samples analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study start17 Mar 2017
- Primary completion13 Sep 2025 (estimated)
- Study completion13 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity; EndocrineStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008525
- Sponsor's protocol ID
- 2016-23
- Acronym
- VITADOSE
- Status last verified
- May 2023
- First submitted
- 29 Dec 2016
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D and Its Metabolites Quantification in Adipose Tissues of Obese and Non-obese
- ClinicalTrials.gov ID
- NCT03008525
- Acronym / sponsor ID
- VITADOSE / 2016-23
- Conditions
- Obesity; Endocrine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 13 Sep 2025 (estimated)
- Study completion
- 13 Sep 2026 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese patients (group OB) | Experimental | Biological: subcutaneous and visceral adipose tissue biopsies, Biological: blood samples analysispatients with body mass index ≥ 35 kg/m² |
| non-obese patients (group NO) | Active comparator | Biological: subcutaneous and visceral adipose tissue biopsies, Biological: blood samples analysispatients with body mass index < 30 kg/m² |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- Regular intake of dietary supplements or vitamin supplements in the last three months
- For the subjects of the group NO:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous and visceral adipose tissue biopsiesSubcutaneous and visceral adipose tissue biopsies during operation | Biological | non-obese patients (group NO), obese patients (group OB) |
| blood samples analysisBlood 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. | Biological | non-obese patients (group NO), obese patients (group OB) |
Primary outcome
quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous and visceral adipose tissue biopsies and blood samples analysis in people with Obesity; Endocrine, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rene VALERO (0491383393 ext. 33, rene.valero@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantification of VD and its metabolites on subcutaneous and visceral adipose tissue biopsies (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.