Brief Title
Corticosteroid-induced Lipodystrophy and Adipokines
Official Title
Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy
Brief Summary
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
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.
Study Type
Observational
Primary Outcome
Expression of adiponectin in adipocytes
Secondary Outcome
Plasma levels of adiponectin, leptin, sTNFR1, and IL6
Condition
Lipodystrophy
Intervention
Samples and procedures
Study Arms / Comparison Groups
1
Description: Patients with corticotherapy lasting more than 3 months
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
32
Start Date
August 2006
Completion Date
November 2008
Primary Completion Date
October 2008
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Laurence FARDET, MD PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00822042
Organization ID
P 051037
Secondary IDs
CIRC 05147
Responsible Party
Sponsor
Study Sponsor
Assistance Publique - Hôpitaux de Paris
Study Sponsor
Laurence FARDET, MD PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
Verification Date
January 2009