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NCT02663388 Clinical Trial

Epigenetic Mechanisms and Severe Obesity (Biological Tissue Collection)

Obesity Clinical Trial

— OBESEPI  

Official title:
Influence of Vitamins Status on Severe Obesity Related Complications

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02663388
Other study ID # 2015-A01175-44
Secondary ID
Status Recruiting
Phase N/A
First received January 11, 2016
Last updated October 26, 2016
Start date January 2016
Est. completion date January 2026

Study information
Verified date October 2016
Source University of Lorraine
Contact Laurent BRUNAUD, MD, PhD
Email l.brunaud@chu-nancy.fr
Is FDA regulated No
Health authority France: Direction Générale de la Santé
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study was to evaluate the role of vitamin status and epigenetic mechanisms on severe obesity related-complications.

Recruitment information / eligibility
Status Recruiting
Enrollment 20000
Est. completion date January 2026
Est. primary completion date January 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• gastric bypass, sleeve, gastric banding

Locations
Country Name City State
France University of Lorraine, CHU Nancy Vandoeuvre Les Nancy

Sponsors (2)
Lead Sponsor Collaborator
University of Lorraine Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of folate mediated one-carbon metabolic pathway parameters (Folates, Vitamin B12, Methionine, Homocysteine) on severe obesity-related complications before and after bariatric surgery 10 years No
Secondary Evaluation of DNA Methylation on severe obesity-related complications before and after bariatric surgery 10 years No
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