A Biological Atlas of Severe Obesity (Biological Tissue Collection)
NCT ID: NCT01129297
Last Updated: 2025-12-08
Study Results
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Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2006-06-13
2027-06-30
Brief Summary
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We now proposed a prospective cohort study to improve our understanding of the influence of phenotypic characteristics on gene expression in tissues involved in glucose and/or lipid metabolism by collecting different biological samples.
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Detailed Description
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This study will examine the contribution of different genetic variants on "diabesity" development, by integrating multiple genomics approaches (linkage analysis on whole genome, transcriptomics and bioinformatics) and analysis of biological pathways in relevant animals models and humans.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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BMI ≥ 35 kg/m2 and diabetes
BMI (Body Mass Index) ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)
No interventions assigned to this group
BMI ≥ 35 kg/m2 with intolerance glucose
BMI (Body Mass Index) ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose\> 6 mmol/L and \<7 mmol/l and / or\> 7.8 mmol/l and \<11.1 mmol/l , 120 minutes after ingestion of glucose (oral glucose tolerance test)
No interventions assigned to this group
BMI ≥ 35 kg/m2 without diabetes
BMI (Body Mass Index)≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)
No interventions assigned to this group
BMI <27 kg/m2 without diabetes
BMI (Body Mass Index) \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)
No interventions assigned to this group
27 < BMI < 35 kg/m2 without diabetes
BMI (Body Mass Index) \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (oral glucose tolerance test)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Indication of abdominal surgery requiring a laparotomy or laparoscopy for bariatric surgery, cholecystectomy, or parietal surgical
* Phenotype corresponding to one of the following four cases :
1. Body Mass Index ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
2. Body Mass Index ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose\> 6 mmol/L and \<7 mmol/l and/or\> 7.8 mmol/l and \<11.1 mmol/l , 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
3. Body Mass Index ≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
4. Body Mass Index \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
5)27 \<Body Mass Index \<35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route)
Exclusion Criteria
* refusal to sign the consent form
* pathology associated judged by the surgeon, may increase the risk of adverse events related to sampling tissue
18 Years
65 Years
ALL
Yes
Sponsors
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University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Francois PATTOU, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Lille University Hospital
Locations
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Lille University Hospital
Lille, Nord, France
Countries
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Central Contacts
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Facility Contacts
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François PATTOU, MD, PhD
Role: primary
References
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Lien F, Berthier A, Bouchaert E, Gheeraert C, Alexandre J, Porez G, Prawitt J, Dehondt H, Ploton M, Colin S, Lucas A, Patrice A, Pattou F, Diemer H, Van Dorsselaer A, Rachez C, Kamilic J, Groen AK, Staels B, Lefebvre P. Metformin interferes with bile acid homeostasis through AMPK-FXR crosstalk. J Clin Invest. 2014 Mar;124(3):1037-51. doi: 10.1172/JCI68815. Epub 2014 Feb 17.
Saux P, Bauvin P, Raverdy V, Teigny J, Verkindt H, Soumphonphakdy T, Debert M, Jacobs A, Jacobs D, Monpellier V, Lee PC, Lim CH, Andersson-Assarsson JC, Carlsson L, Svensson PA, Galtier F, Dezfoulian G, Moldovanu M, Andrieux S, Couster J, Lepage M, Lembo E, Verrastro O, Robert M, Salminen P, Mingrone G, Peterli R, Cohen RV, Zerrweck C, Nocca D, Le Roux CW, Caiazzo R, Preux P, Pattou F. Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study. Lancet Digit Health. 2023 Oct;5(10):e692-e702. doi: 10.1016/S2589-7500(23)00135-8. Epub 2023 Aug 29.
Margerie D, Lefebvre P, Raverdy V, Schwahn U, Ruetten H, Larsen P, Duhamel A, Labreuche J, Thuillier D, Derudas B, Gheeraert C, Dehondt H, Dhalluin Q, Alexandre J, Caiazzo R, Nesslany P, Verkindt H, Pattou F, Staels B. Hepatic transcriptomic signatures of statin treatment are associated with impaired glucose homeostasis in severely obese patients. BMC Med Genomics. 2019 Jun 3;12(1):80. doi: 10.1186/s12920-019-0536-1.
Other Identifiers
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DGS 2006/0307
Identifier Type: OTHER
Identifier Source: secondary_id
2006_0620
Identifier Type: -
Identifier Source: org_study_id
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