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Corticosteroid-induced Lipodystrophy and Adipokines (ADIPOKINES)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00822042
First Posted: January 14, 2009
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Plasma levels of adiponectin, leptin, sTNFR1, and IL6 [ Time Frame: at the inclusion and M3 visits ]
  • Histological morphology of adipocytes [ Time Frame: at the inclusion and M3 visits ]
  • Expression of leptin, IL6, TNFa, 11bHSD1, SREBP1c and PPARg in adipocytes [ Time Frame: at the inclusion and M3 visits ]

Biospecimen Retention:   Samples Without DNA
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00822042     History of Changes
Other Study ID Numbers: P 051037
CIRC 05147
First Submitted: January 13, 2009
First Posted: January 14, 2009
Last Update Posted: February 27, 2014
Last Verified: January 2009

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lipodystrophy
Adipokines
Glucocorticoids
Patients with glucocorticoids

Additional relevant MeSH terms:
Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs