Corticosteroid-induced Lipodystrophy and Adipokines

Completed

• Conditions: Lipodystrophy
• Interventions: Other: Samples and procedures

• Registration Number: NCT00822042
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study Start: 2006-08
• Primary Completion: 2008-10
• Study Completion: 2008-11
• Status Verified: 2009-01
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• adult patient
• starting therapy with prednisone
• corticosteroid therapy lasting more than 3 months
• baseline prednisone dosage >= 0.5 mg/kg/d

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Exclusion Criteria

• Cushing disease
• HIV +Pregnancy
• Recent weight lost (> 5% of the usual weight)
• Therapy with glucocorticosteroids during the past 6 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Samples and procedures	Patients with corticotherapy lasting more than 3 months

Primary Outcome Measures

Name	Time	Method
Expression of adiponectin in adipocytes	at the inclusion and M3 visits

Secondary Outcome Measures

Name	Time	Method
Plasma levels of adiponectin, leptin, sTNFR1, and IL6	at the inclusion and M3 visits
Expression of leptin, IL6, TNFa, 11bHSD1, SREBP1c and PPARg in adipocytes	at the inclusion and M3 visits
Histological morphology of adipocytes	at the inclusion and M3 visits

Trial Locations

Locations (1)

Hopital Saint-Antoine; 🇫🇷 Paris, France