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
  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 ] [ 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

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
Other Name: Samples and procedures

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00822042     History of Changes
Other Study ID Numbers: P 051037, CIRC 05147
Study First Received: January 13, 2009
Last Updated: February 26, 2014
Health Authority: France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 21, 2014