Corticosteroid-induced Lipodystrophy and Adipokines

NCT00822042 | Completed

• 2 other identifiers: P 051037CIRC 05147
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lipodystrophy

Keywords

Lipodystrophy; Adipokines; Glucocorticoids; Patients with glucocorticoids

Outcome Measures

Primary Outcomes (1)

• Expression of adiponectin in adipocytes

  at the inclusion and M3 visits

Secondary Outcomes (3)

• Plasma levels of adiponectin, leptin, sTNFR1, and IL6

  at the inclusion and M3 visits

• Histological morphology of adipocytes

  at the inclusion and M3 visits

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

  at the inclusion and M3 visits

Study Arms (1)

1

Patients with corticotherapy lasting more than 3 months

Other: Samples and procedures

Interventions

Samples and procedures OTHER

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting in participating units

You may qualify if:

• adult patient
• starting therapy with prednisone
• corticosteroid therapy lasting more than 3 months
• baseline prednisone dosage \>= 0.5 mg/kg/d

You may not qualify if:

• Cushing disease
• HIV +Pregnancy
• Recent weight lost (\> 5% of the usual weight)
• Therapy with glucocorticosteroids during the past 6 months

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Saint-Antoine

Paris, 75012, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cytopunction (adipocytes), whole blood

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

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

Study Officials

• Laurence FARDET, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: August 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: February 27, 2014

Record last verified: 2009-01

Locations

FR (1)