Epigenetic Mechanisms and Severe Obesity (Biological Tissue Collection) (OBESEPI)

October 26, 2016 updated by: Laurent Brunaud, University of Lorraine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Vandoeuvre Les Nancy, France, 54511
        • Recruiting
        • University of Lorraine, CHU Nancy
        • Contact:
          • Laurent Brunaud
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who undergo bariatric surgery following french national guidelines (HAS 2009)

Description

Inclusion Criteria:

  • indication for bariatric surgery with BMI > 35 kg/m2

Exclusion Criteria:

  • unable to receive clear information
  • refusal to sign the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of DNA Methylation on severe obesity-related complications before and after bariatric surgery
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lorraine

Collaborators

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: laurent BRUNAUD, MD, PhD, University of Lorraine, CHU Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01175-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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