Corticosteroid-Induced Lipodystrophy and Adipokines - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00822042

Purpose

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

Condition	Intervention
Lipodystrophy	Other: Samples and procedures

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-Induced Lipodystrophy

Resource links provided by NLM:

Drug Information available for: Corticosteroids

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Expression of adiponectin in adipocytes [ Time Frame: at the inclusion and M3 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Cytopunction (adipocytes), whole blood

Enrollment:	32
Study Start Date:	August 2006
Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with corticotherapy lasting more than 3 months	Other: Samples and procedures Scanner, histomorphometry : at the inclusion and M3 visits whole blood samples, cytoponction : at the inclusion and M3 visits

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients consulting in participating units

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822042

Locations

France
Hopital Saint-Antoine
Paris, France, 75012

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Laurence FARDET, MD PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department Clinical Research of Developpement ( Myriem Carrier )
Study ID Numbers:	P 051037, CIRC 05147
Study First Received:	January 13, 2009
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00822042 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Lipodystrophy
Adipokines
Glucocorticoids
Patients with glucocorticoids

Study placed in the following topic categories:

Metabolic Diseases
Skin Diseases
Lipodystrophy

Glucocorticoids
Metabolic Disorder
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Skin Diseases
Skin Diseases, Metabolic
Lipodystrophy
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 01, 2009