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Macrophage Infiltration in Human Adipose Tissue

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00476658
Collaborator
(none)
200
Enrollment
1
Location
57
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Obesity results from a disequilibrium in energy balance and an inability to adapt to lifestyles which encourage increased energy intake and sedentariness. These last years, numerous studies contributed to show that obesity is the pathology of an organ, the white adipose tissue (AT), characterized by a low grade inflammation when it is enlarged. The fact that adipocytes secrete a number of inflammatory factors or "adipokines" has forced several groups to reassess the involvement of the AT in wide range of physiological and pathophysiological processes. Adipose tissue probably contributes to the links between obesity, inflammation and insulin-resistance. Our previous results based on transcriptomics studies, showed that genes encoding inflammatory molecules are mobilized in adipose tissue of obese subjects and that caloric restriction improves greatly inflammatory profile. Our preliminary studies on the morphology of adipose tissue lead us to observe a major infiltration of macrophages in morbidly obese subjects. This project is based on a clinical protocol performed in massively obese subjects (BMI>40 kg/m²), where drastic weight loss is achieved by gastric bypass. This project has several objectives. It will allow us to characterize the infiltration of macrophages in the subcutaneous adipose tissue of 60 obese subjects compared with 20 normal-weight subjects, to study the evolution during surgically-induced weight loss and to compare the infiltration observed in adipose tissue to that of other tissues (visceral adipose tissue, muscle, liver, bowel and stomach). This study will be not only quantitative (number of macrophages) but also qualitative by characterizing the phenotype of macrophages with transcriptomics and immunohistochemical approaches. We will analyze the relationships between morphological characteristics of adipose tissue and clinical and biochemical parameters related to insulin sensitivity. More generally, this project might lead us to go thoroughly into the knowledge of the link between obesity and associated comorbidities, particularly metabolic complications, and to consider novels therapeutic strategies.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterisation of Macrophage Infiltration in Obesity and Its Complications
    Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    Oct 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 60 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 APHP Hopital Hotel Dieu Paris France 75004

      Sponsors and Collaborators

      • Assistance Publique - Hôpitaux de Paris

      Investigators

      • Principal Investigator: Christine POITOU-BERNERT, MD,PhD, Assistance Publique - Hôpitaux de Paris

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Assistance Publique - Hôpitaux de Paris
      ClinicalTrials.gov Identifier:
      NCT00476658
      Other Study ID Numbers:
      • P050318
      First Posted:
      May 22, 2007
      Last Update Posted:
      Dec 7, 2011
      Last Verified:
      May 1, 2007
      Keywords provided by Assistance Publique - Hôpitaux de Paris
      Obesity
      macrophage infiltration
      insulinoresistance
      inflammation
      Additional relevant MeSH terms:
      Obesity

      Study Results

      No Results Posted as of Dec 7, 2011