Lipophilic Organic Polluants and Morbid Obesity
POLOB
1 other identifier
interventional
232
1 country
1
Brief Summary
- 1.To study the kinetics of release after bariatric surgery of selected polluants stored in adipose tissue, looking for clinical and/or predictive factors
- 2.To test the hypothesis of a deleterious effect of this release on the expected improvement of insulin-resistance and on the liver inflammation.
- 3.To determine the level of contamination of morbidly obese patients, with or without metabolic syndrome, compared to a control, non obese population, with special attention to clinical (age, gender, reproductive history, pregnancy, nursing) and biological parameters (insulin-resistance, inflammation).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Dec 2013
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedStudy Start
First participant enrolled
December 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2017
CompletedNovember 18, 2023
November 1, 2023
3.8 years
October 22, 2013
November 15, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
measurement of POPs
Urinary and blood POPs dosage 18 months after bariatric surgery
18 months
clinical and biological assessment of metabolic syndrome
blood dosage for clinical and biological assessment of metabolic syndrome including glucose tolerance test 18 months after bariatric surgery
18 months after bariatric surgery
Secondary Outcomes (2)
Kinetic profiles of POP release within 18 months following bariatric surgery
18 months following bariatric surgery
Total body burden of selected POPs before and after surgery
before surgery and 18 months after surgery
Study Arms (3)
sleeve bariatric surgery
OTHERmorbidly obese adults, with or without metabolic syndrome eligible for bariatric surgery undergoing sleeve gastrectomy
morbidly obese adults with by pass surgery
OTHERmorbidly obese adults, with or without metabolic syndrome eligible for bariatric surgery undergoing gastric bypass
non obese
OTHERnon obese patients
Interventions
Urinary, blood and fat dosage of Lipophilic Organic Polluants
Eligibility Criteria
You may qualify if:
- age 18 to 65 years
- health coverage
- mentally competent
- signed consent form
- stable weight over the last three months
- pregnancy
- insulin treated diabetes
- significant weight change over the last three months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nice University Hospital
Nice, 06000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick FENICHEL, PhD
Nice University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 25, 2013
Study Start
December 18, 2013
Primary Completion
September 19, 2017
Study Completion
September 19, 2017
Last Updated
November 18, 2023
Record last verified: 2023-11