NCT01655017

Brief Summary

Adipose tissue (AT) has specific alterations in obesity in particular increased fibrosis amount compared to lean subjects. Fibrosis amount measured by immunohistochemistry on adipose biopsies appears to to predict weight loss response after a bariatric surgery. Non invasive tools to measure fibrosis needs to be validated. The investigators primary aim is to validate a new device able to measure adipose tissue stiffness. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
281

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

6.2 years

First QC Date

April 25, 2012

Last Update Submit

November 10, 2020

Conditions

ObesityMetabolic DiseasesFibrosisBody Weight

Keywords

Obesityadipose tissue fibrosisAdipose tissue inflammationLow grade systemic inflammationnon invasive deviceBariatric surgery

Outcome Measures

Primary Outcomes (1)

  • Adipose tissue stiffness and fibrosis

    In both massively obese patients and in a subgroup of lean and overweight control, adipose tissue stiffness will be assessed using the elastography non invasive device. Adipose tissue fibrosis will be evaluated using immuno-chemistry staining upon adipose tissue surgical biopsy and defined as the ratio of the surface stained with picrosirius and the surface of the biopsy. The investigators will then look for a strong statistical association between those two measures to validate our new device.

    baseline

Secondary Outcomes (8)

  • weight loss one year after surgery

    12 months

  • Severity of obesity related disease before surgery (in particular NASH acknowledged on liver histology)

    baseline

  • Obesity related disease improvement one year after surgery.

    12 months

  • Adipose tissue fibrosis and weight loss response

    3 months

  • Adipose tissue stiffness and weight loss response

    3 months

  • +3 more secondary outcomes

Study Arms (2)

biopsy

EXPERIMENTAL

Obesity with BMI\> 40 kg/m² or obesity with BMI between \>35 kg/m² with comorbidities (OSA, type 2 diabetes, hypertension etc…)

Procedure: biopsy

healthy volunteers

NO INTERVENTION

biopsy during a surgery

Interventions

biopsyPROCEDURE

adipose tissue biopsy (to evaluate inflammation and fibrosis)

biopsy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese population :
  • 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

You may not qualify if:

  • Inflammatory disease
  • Pregnancy
  • cancer
  • Drugs (AINS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de Chirurgie générale et digestive et d'oncologie du Pr Nordlinger -Ambroise Paré

Boulogne, 92100, France

Location

Service de nutrition du Pr Basdevant -Pitié salpêtrière/ Institut Cardiometabolism and nutrition

Paris, 75013, France

Location

Related Publications (6)

  • 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.

    PMID: 37302712DERIVED

  • 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.

    PMID: 34905051DERIVED

  • 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.

    PMID: 33125520DERIVED

  • 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.

    PMID: 28419237DERIVED

  • 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.

    PMID: 26583585DERIVED

  • 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.

    PMID: 26205215DERIVED

MeSH Terms

Conditions

ObesityMetabolic DiseasesFibrosisBody Weight

Interventions

Biopsy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Judith Aron-wisnewsky, MD

    APHP

    PRINCIPAL INVESTIGATOR

  • Karine Clement, MD, PhD

    APHP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

August 1, 2012

Study Start

February 8, 2012

Primary Completion

April 6, 2018

Study Completion

April 6, 2018

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations

FR(2)