Corticosteroid-induced Lipodystrophy and Adipokines

Study Overview
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Brief Summary
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Hypothesis: systemic therapy with corticosteroid induces morphological changes (e.g., moon face, buffalo neck) called lipodystrophy (LD). We hypothesize that this LD is associated with variation of adipocytokines (e.g., adiponectin, leptine, IL6) levels Primary objective: To show a 50% decrease in adipocytes adiponectin's expression in patients who developed LD versus those who did not developed LD during the first 3 months of a systemic therapy with corticosteroids Secondary objectives: To look for differences in the mRNA expression of 11bHSD1, SREBP1c and PPARg in fat samples of patients before and after treatment with systemic corticosteroids and between LD+ and LD-patients To compare the fat morphology before and after treatment with glucosteroids

Detailed Description
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Design: Monocentric, cross-sectional analytical study Subjects: 32 HIV-free and Cushing disease-free adult patients for whom a prolonged treatment (³3months) with glucosteroids (³ 0.5 mg/kg/day) is initiated Methods: At treatment initiation and 3 months after: comparison of fat sample mRNA expression of adipokines (adiponectin, leptin, IL6, TNFa), 11bHSD1, SREBP1c and PPARg, fat morphology and seric concentrations of adiponectin, leptin, IL6, sTNFR1 between patients LD+ and patients LD-. The diagnosis of LD will be performed by 3 experts using patients photographs Aims of this study: To gain a better understanding of the pathophysiology of glucosteroids-induced LD To compare this pathophysiology to the one of HIV-associated LD for which the hypothesis of a local, cellular, hypercorticism has been put forward and for which related treatment have been prescribed.

Official Title
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Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy

Conditions
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Lipodystrophy

Intervention / Treatment
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* Other: Samples and procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patient starting therapy with prednisone corticosteroid therapy lasting more than 3 months baseline prednisone dosage >= 0.5 mg/kg/d Exclusion Criteria: Cushing disease HIV +Pregnancy Recent weight lost (> 5% of the usual weight) Therapy with glucocorticosteroids during the past 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with corticotherapy lasting more than 3 months | Other: Samples and procedures<br>* Scanner, histomorphometry : at the inclusion and M3 visits whole blood samples, cytoponction : at the inclusion and M3 visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of adiponectin in adipocytes |  | at the inclusion and M3 visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of adiponectin, leptin, sTNFR1, and IL6 |  | at the inclusion and M3 visits | 
| Histological morphology of adipocytes |  | at the inclusion and M3 visits | 
| Expression of leptin, IL6, TNFa, 11bHSD1, SREBP1c and PPARg in adipocytes |  | at the inclusion and M3 visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lipodystrophy, Adipokines, Glucocorticoids, Patients with glucocorticoids