Corticosteroid-induced Lipodystrophy and Adipokines

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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