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NCT Number: NCT00822042

Corticosteroid-induced Lipodystrophy and Adipokines

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

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Key information

Conditions

Lipodystrophy Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Saint-Antoine

Paris, 75012, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samples and procedures

Other
  • Scanner, histomorphometry : at the inclusion and M3 visits
  • whole blood samples, cytoponction : at the inclusion and M3 visits

Primary outcomes

  1. Expression of adiponectin in adipocytes

    Time frame: at the inclusion and M3 visits

Secondary outcomes

  1. Plasma levels of adiponectin, leptin, sTNFR1, and IL6

    Time frame: at the inclusion and M3 visits

  2. Histological morphology of adipocytes

    Time frame: at the inclusion and M3 visits

  3. Expression of leptin, IL6, TNFa, 11bHSD1, SREBP1c and PPARg in adipocytes

    Time frame: at the inclusion and M3 visits

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-induced Lipodystrophy

Acronym: ADIPOKINES

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 14, 2009
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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