NCT00476658

Brief Summary

Quantification of macrophage infiltration and characterization of macrophage phenotype in adipose tissue of 60 obese subjects and 20 non obese subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 7, 2011

Status Verified

May 1, 2007

Enrollment Period

4.8 years

First QC Date

May 21, 2007

Last Update Submit

December 6, 2011

Conditions

ObesityDiabetes

Keywords

Obesitymacrophage infiltrationinsulinoresistanceinflammation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: * Obese subjects group : * Obesity with BMI\> 40 kg/m² or obesity with BMI between 35 and 40 kg/M² with comorbidities (OAS, diabetes, hypertension etc…) * Age: 18-60 * Non obese subjects group * Abdominal surgery planned * Age: 18-60 Exclusion Criteria: * Inflammatory disease * cancer * stroke * Drugs (AINS)

You may qualify if:

  • Obese subjects group :
  • Obesity with BMI\> 40 kg/m² or obesity with BMI between 35 and 40 kg/M² with comorbidities (OAS, diabetes, hypertension etc…)
  • Age: 18-60
  • Non obese subjects group
  • Abdominal surgery planned
  • Age: 18-60

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP Hopital Hotel Dieu

Paris, 75004, France

Location

Related Publications (5)

  • 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

  • Sell H, Poitou C, Habich C, Bouillot JL, Eckel J, Clement K. Heat Shock Protein 60 in Obesity: Effect of Bariatric Surgery and its Relation to Inflammation and Cardiovascular Risk. Obesity (Silver Spring). 2017 Dec;25(12):2108-2114. doi: 10.1002/oby.22014. Epub 2017 Oct 11.

    PMID: 29024428DERIVED

  • Reggio S, Rouault C, Poitou C, Bichet JC, Prifti E, Bouillot JL, Rizkalla S, Lacasa D, Tordjman J, Clement K. Increased Basement Membrane Components in Adipose Tissue During Obesity: Links With TGFbeta and Metabolic Phenotypes. J Clin Endocrinol Metab. 2016 Jun;101(6):2578-87. doi: 10.1210/jc.2015-4304. Epub 2016 Apr 6.

    PMID: 27049236DERIVED

  • Poitou C, Dalmas E, Renovato M, Benhamo V, Hajduch F, Abdennour M, Kahn JF, Veyrie N, Rizkalla S, Fridman WH, Sautes-Fridman C, Clement K, Cremer I. CD14dimCD16+ and CD14+CD16+ monocytes in obesity and during weight loss: relationships with fat mass and subclinical atherosclerosis. Arterioscler Thromb Vasc Biol. 2011 Oct;31(10):2322-30. doi: 10.1161/ATVBAHA.111.230979. Epub 2011 Jul 28.

    PMID: 21799175DERIVED

  • Dalmas E, Rouault C, Abdennour M, Rovere C, Rizkalla S, Bar-Hen A, Nahon JL, Bouillot JL, Guerre-Millo M, Clement K, Poitou C. Variations in circulating inflammatory factors are related to changes in calorie and carbohydrate intakes early in the course of surgery-induced weight reduction. Am J Clin Nutr. 2011 Aug;94(2):450-8. doi: 10.3945/ajcn.111.013771. Epub 2011 Jun 15.

    PMID: 21677057DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

adipose tissue, visceral adipose tissue, muscle, liver, bowel and stomach

MeSH Terms

Conditions

ObesityDiabetes MellitusInflammation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesPathologic Processes

Study Officials

  • Christine POITOU-BERNERT, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2007

First Posted

May 22, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 7, 2011

Record last verified: 2007-05

Locations

FR(1)