ObesityOBESEPINCT02663388
Epigenetic Mechanisms and Severe Obesity (Biological Tissue Collection)
An observational study of Obesity and Diabetes, run by University of Lorraine at 1 site in France.
Trial summary
The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Metabolic Diseases
- What is being tested?
- gastric bypass, sleeve, gastric banding
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jan 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who undergo bariatric surgery following french national guidelines (HAS 2009)
Who may be able to join
- indication for bariatric surgery with BMI > 35 kg/m2
Who cannot join
- unable to receive clear information
- refusal to sign the consent form
Trial locations and contacts
1 site in 1 country.
Laurent BRUNAUD, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
University of Lorraine, CHU Nancy
Vandœuvre-lès-Nancy, 54511
laurent brunaud, l.brunaud@chu-nancy.fr
laurent brunaud
About this study
Official title: Influence of Vitamins Status on Severe Obesity Related Complications
The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.
- Being tested
- gastric bypass, sleeve, gastric banding
- Medical subject headings
- Obesity, Diabetes Mellitus, Metabolic Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypass, sleeve, gastric bandingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of folate mediated one-carbon metabolic pathway parameters (Folates, Vitamin B12, Methionine, Homocysteine) on severe obesity-related complications before and after bariatric surgery
Measured: 10 years
Secondary outcomes (1)
Evaluation of DNA Methylation on severe obesity-related complications before and after bariatric surgery
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Responsible party
- Principal investigator, Laurent Brunaud, University of Lorraine
- Investigators
- laurent BRUNAUD, MD, PhD, Principal investigator, University of Lorraine, CHU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663388
- Sponsor's protocol ID
- 2015-A01175-44
- Acronym
- OBESEPI
- Status last verified
- Oct 2016
- First submitted
- 11 Jan 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
Publications
Chabi N, Nomine-Criqui C, Heinken A, Quilliot D, Brunaud L, Li Z, Jeannesson-Thivisol E, Sanni A, Ziegler O, Gueant JL, Gueant-Rodriguez RM. Acylcarnitines Are Associated with Metabolic Syndrome and Hypertension in Two Contrasted Obese Populations. Nutrients. 2026 Apr 1;18(7):1137. doi: 10.3390/nu18071137.
PubMed 41978187Antoine D, Li Z, Quilliot D, Sirveaux MA, Meyre D, Mangeon A, Brunaud L, Gueant JL, Gueant-Rodriguez RM. Medium term post-bariatric surgery deficit of vitamin B12 is predicted by deficit at time of surgery. Clin Nutr. 2021 Jan;40(1):87-93. doi: 10.1016/j.clnu.2020.04.029. Epub 2020 Apr 25.
PubMed 32444241Li Z, Gueant-Rodriguez RM, Quilliot D, Sirveaux MA, Meyre D, Gueant JL, Brunaud L. Folate and vitamin B12 status is associated with insulin resistance and metabolic syndrome in morbid obesity. Clin Nutr. 2018 Oct;37(5):1700-1706. doi: 10.1016/j.clnu.2017.07.008. Epub 2017 Jul 24.
PubMed 28780990
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vitamins Status on Severe Obesity Related Complications
- ClinicalTrials.gov ID
- NCT02663388
- Acronym / sponsor ID
- OBESEPI / 2015-A01175-44
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Study start
- Jan 2016
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 26 Jan 2016 (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.
The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo bariatric surgery following french national guidelines (HAS 2009)
Key inclusion criteria (1 listed)
- indication for bariatric surgery with BMI > 35 kg/m2
Key exclusion criteria (2 listed)
- unable to receive clear information
- refusal to sign the consent form
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 |
|---|---|---|
| gastric bypass, sleeve, gastric banding | Procedure or surgery | – |
Primary outcome
Evaluation of folate mediated one-carbon metabolic pathway parameters (Folates, Vitamin B12, Methionine, Homocysteine) on severe obesity-related complications before and after bariatric surgery
Time frame: 10 years
1 secondary outcome
Evaluation of DNA Methylation on severe obesity-related complications before and after bariatric surgery
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: PubMed 41978187Chabi N, Nomine-Criqui C, Heinken A, Quilliot D, Brunaud L, Li Z, Jeannesson-Thivisol E, Sanni A, Ziegler O, Gueant JL, Gueant-Rodriguez RM. Acylcarnitines Are Associated with Metabolic Syndrome and Hypertension in Two Contrasted Obese Populations. Nutrients. 2026 Apr 1;18(7):1137. doi: 10.3390/nu18071137.
- Derived from this study: PubMed 32444241Antoine D, Li Z, Quilliot D, Sirveaux MA, Meyre D, Mangeon A, Brunaud L, Gueant JL, Gueant-Rodriguez RM. Medium term post-bariatric surgery deficit of vitamin B12 is predicted by deficit at time of surgery. Clin Nutr. 2021 Jan;40(1):87-93. doi: 10.1016/j.clnu.2020.04.029. Epub 2020 Apr 25.
- Derived from this study: PubMed 28780990Li Z, Gueant-Rodriguez RM, Quilliot D, Sirveaux MA, Meyre D, Gueant JL, Brunaud L. Folate and vitamin B12 status is associated with insulin resistance and metabolic syndrome in morbid obesity. Clin Nutr. 2018 Oct;37(5):1700-1706. doi: 10.1016/j.clnu.2017.07.008. Epub 2017 Jul 24.
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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.
Laurent BRUNAUD, MD, PhD contact
laurent BRUNAUD, MD, PhD principal investigator
University of Lorraine, CHU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes, run by University of Lorraine 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 1 inclusion and 2 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 Oct 2016. 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 Laurent BRUNAUD, MD, PhD (l.brunaud@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of folate mediated one-carbon metabolic pathway parameters (Folates, Vitamin B12, Methionine, Homocysteine) on severe obesity-related complications before and after bariatric surgery (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02663388, which also lists 3 linked publications.
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 Oct 2016.