Corticosteroid-induced Lipodystrophy and Adipokines (ADIPOKINES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00822042
First received: January 13, 2009
Last updated: February 26, 2014
Last verified: January 2009

January 13, 2009
February 26, 2014
August 2006
October 2008   (final data collection date for primary outcome measure)
Expression of adiponectin in adipocytes [ Time Frame: at the inclusion and M3 visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822042 on ClinicalTrials.gov Archive Site
  • Plasma levels of adiponectin, leptin, sTNFR1, and IL6 [ Time Frame: at the inclusion and M3 visits ] [ Designated as safety issue: No ]
  • Histological morphology of adipocytes [ Time Frame: at the inclusion and M3 visits ] [ Designated as safety issue: No ]
  • Expression of leptin, IL6, TNFa, 11bHSD1, SREBP1c and PPARg in adipocytes [ Time Frame: at the inclusion and M3 visits ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Corticosteroid-induced Lipodystrophy and Adipokines
Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy

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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Cytopunction (adipocytes), whole blood

Non-Probability Sample

Patients consulting in participating units

Lipodystrophy
Other: Samples and procedures
  • Scanner, histomorphometry : at the inclusion and M3 visits
  • whole blood samples, cytoponction : at the inclusion and M3 visits
Other Name: Samples and procedures
1
Patients with corticotherapy lasting more than 3 months
Intervention: Other: Samples and procedures
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00822042
P 051037, CIRC 05147
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Laurence FARDET, MD PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP