Study Results
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Basic Information
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COMPLETED
NA
281 participants
INTERVENTIONAL
2012-02-08
2018-04-06
Brief Summary
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Thus the investigators plan to compare the stiffness results obtained with the device to the quantification of fibrosis using immuno-chemistry in massively obese patient's candidates to a bariatric surgery.
Detailed Description
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To date fibrosis can only be measured using by immunohistochemistry after surgical biopsy. To that prospect, non invasive tools need to be validated, in particular device able to measure adipose tissue stiffness. The investigators hypothesis is that this new device is as powerful as IHC-quantified fibrosis to predict surgery induced weight loss.
To answer that question the investigators will evaluate adipose tissue stiffness with the device as well as quantify fibrosis using immuno-chemistry on AT biopsy in morbidly obese patients before and during the first year after a bariatric surgery.
The first objective is to validate the investigators new device by comparing both invasive fibrosis measurement on adipose tissue and non invasive stiffness measure The investigators second objective is to assess whether the investigators device can predict weight loss repose after bariatric surgery.
This project is based on a clinical protocol performed in massively obese subjects (BMI\>40 kg/m² or BMI\>35kg/m² with comorbidities). The investigators will recruit 250 obese patients addressed for bariatric surgery (bypass, sleeve or gastric banding). Clinical phenotype, biochemical analysis, body composition, systemic inflammation, adipose tissue biopsy (to evaluate inflammation and fibrosis) will be assessed at baseline and 3 and 12 months after surgery. Also at baseline surgical sub cutaneous and omental adipose tissue (to evaluate inflammation and fibrosis) as well as liver biopsy (to score non alcoholic hepatitis) will be analysed. 50 non obese patients will serve as controls. Adipose tissue stiffness measured with the device as well as fibrosis quantification on subcutaneous and omental adipose tissue will be assessed at baseline during programmed non inflammatory abdominal surgery Associations between all clinical and biological parameters will be assessed at the different point of the follow up.
More generally, this project might lead us to elucidate whether fibrosis in adipose tissue can predict surgery outcome in terms of weight loss and obesity related complications improvement. Also the investigators want to validate a new non invasive tool to measure adipose tissue fibrosis and check whether it can predict surgery outcomes.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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biopsy
Obesity with BMI\> 40 kg/m² or obesity with BMI between \>35 kg/m² with comorbidities (OSA, type 2 diabetes, hypertension etc…)
biopsy
adipose tissue biopsy (to evaluate inflammation and fibrosis)
healthy volunteers
biopsy during a surgery
No interventions assigned to this group
Interventions
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biopsy
adipose tissue biopsy (to evaluate inflammation and fibrosis)
Eligibility Criteria
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Inclusion Criteria
* Obesity with BMI\> 40 kg/m² or obesity with BMI \>35 kg/m² with comorbidities (OSA, type 2 diabetes, hypertension etc…)
* Age: 18-65
* weight stable for three months preceding surgery
* candidate to a sleeve or bypass or adjustable gastric banding
Controls:
* BMI\< 30 kg/m²
* Age: 18-65
* non inflammatory acute or chronic disease
* candidate to a programmed non inflammatory abdominal surgery
Exclusion Criteria
* Pregnancy
* cancer
* Drugs (AINS)
18 Years
65 Years
ALL
Yes
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Judith Aron-wisnewsky, MD
Role: PRINCIPAL_INVESTIGATOR
APHP
Karine Clement, MD, PhD
Role: STUDY_DIRECTOR
APHP
Locations
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Service de Chirurgie générale et digestive et d'oncologie du Pr Nordlinger -Ambroise Paré
Boulogne, , France
Service de nutrition du Pr Basdevant -Pitié salpêtrière/ Institut Cardiometabolism and nutrition
Paris, , France
Countries
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References
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Torres L, Camila Goncalves Miranda M, Dantas Martins V, Caixeta F, de Almeida Oliveira M, Martins Trindade L, Carvalho de Assis H, Nascimento V, Pinheiro Rosa N, Gomes E, Oliveira Almeida S, Marquet F, Genser L, Marcelin G, Clement K, Russo M, Maria Caetano Faria A, Uceli Maioli T. Obesity-induced hyperglycemia impairs oral tolerance induction and aggravates food allergy. Mucosal Immunol. 2023 Aug;16(4):513-526. doi: 10.1016/j.mucimm.2023.05.008. Epub 2023 Jun 10.
Bel Lassen P, Nori N, Bedossa P, Genser L, Aron-Wisnewsky J, Poitou C, Surabattula R, Juul Nielsen M, Asser Karsdal M, Julie Leeming D, Schuppan D, Clement K. Fibrogenesis Marker PRO-C3 Is Higher in Advanced Liver Fibrosis and Improves in Patients Undergoing Bariatric Surgery. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1356-e1366. doi: 10.1210/clinem/dgab897.
Rouault C, Marcelin G, Adriouch S, Rose C, Genser L, Ambrosini M, Bichet JC, Zhang Y, Marquet F, Aron-Wisnewsky J, Poitou C, Andre S, Derumeaux G, Guerre-Millo M, Clement K. Senescence-associated beta-galactosidase in subcutaneous adipose tissue associates with altered glycaemic status and truncal fat in severe obesity. Diabetologia. 2021 Jan;64(1):240-254. doi: 10.1007/s00125-020-05307-0. Epub 2020 Oct 30.
Bel Lassen P, Charlotte F, Liu Y, Bedossa P, Le Naour G, Tordjman J, Poitou C, Bouillot JL, Genser L, Zucker JD, Sokolovska N, Aron-Wisnewsky J, Clement K. The FAT Score, a Fibrosis Score of Adipose Tissue: Predicting Weight-Loss Outcome After Gastric Bypass. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2443-2453. doi: 10.1210/jc.2017-00138.
Liu Y, Aron-Wisnewsky J, Marcelin G, Genser L, Le Naour G, Torcivia A, Bauvois B, Bouchet S, Pelloux V, Sasso M, Miette V, Tordjman J, Clement K. Accumulation and Changes in Composition of Collagens in Subcutaneous Adipose Tissue After Bariatric Surgery. J Clin Endocrinol Metab. 2016 Jan;101(1):293-304. doi: 10.1210/jc.2015-3348. Epub 2015 Nov 19.
Verger EO, Aron-Wisnewsky J, Dao MC, Kayser BD, Oppert JM, Bouillot JL, Torcivia A, Clement K. Micronutrient and Protein Deficiencies After Gastric Bypass and Sleeve Gastrectomy: a 1-year Follow-up. Obes Surg. 2016 Apr;26(4):785-96. doi: 10.1007/s11695-015-1803-7.
Other Identifiers
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P100503
Identifier Type: -
Identifier Source: org_study_id