- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00822042
Corticosteroid-induced Lipodystrophy and Adipokines (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
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75012
- Hopital Saint-Antoine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patients with corticotherapy lasting more than 3 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Expression of adiponectin in adipocytes
Time Frame: at the inclusion and M3 visits
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at the inclusion and M3 visits
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma levels of adiponectin, leptin, sTNFR1, and IL6
Time Frame: at the inclusion and M3 visits
|
at the inclusion and M3 visits
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Histological morphology of adipocytes
Time Frame: at the inclusion and M3 visits
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at the inclusion and M3 visits
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Expression of leptin, IL6, TNFa, 11bHSD1, SREBP1c and PPARg in adipocytes
Time Frame: at the inclusion and M3 visits
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at the inclusion and M3 visits
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laurence FARDET, MD PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P 051037
- CIRC 05147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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