Corticosteroid-Induced Lipodystrophy and Adipokines (ADIPOKINES)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 13, 2009 | ||||
| Last Updated Date | January 13, 2009 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Expression of adiponectin in adipocytes [ Time Frame: at the inclusion and M3 visits ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Corticosteroid-Induced Lipodystrophy and Adipokines | ||||
| Official Title ICMJE | Study of Histological and Adipokines Expression Variations in Lipodystrophic Adipose Tissue During Corticosteroids-Induced Lipodystrophy | ||||
| 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 |
||||
| 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:
|
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Cytopunction (adipocytes), whole blood |
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients consulting in participating units |
||||
| Condition ICMJE | Lipodystrophy | ||||
| Intervention ICMJE | Other: Samples and procedures
Other Name: Samples and procedures |
||||
| Study Group/Cohort (s) | 1
Patients with corticotherapy lasting more than 3 months
Intervention: Other: Samples and procedures |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 32 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00822042 | ||||
| Other Study ID Numbers ICMJE | P 051037, CIRC 05147 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Myriem Carrier, Department Clinical Research of Developpement | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | January 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||