Obesity Clinical Trial - Macrophage Infiltration in Human Adipose Tissue

Status Completed

Clinical Trial Summary

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

Clinical Trial 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00476658
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	January 2007
Completion date	October 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.