- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01688349
Pattern of Gene Expression in Adipose Tissue From Patients With Cushing Syndrome (LIPOCUSH)
Comparative Study of Subcutaneous and Visceral Adipose Tissue in Patients Affected by Cushing Syndrome Versus 2 Controls Population
The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be
- to compare the pattern of gene expression between visceral and subcutaneous adipose tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment;
- to compare these patterns of gene expression with those of two control populations:1/ healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar degree of insulin resistance.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Cushing's syndrome is a rare disease resulting from chronic exposure to glucocorticoids (endogenous or iatrogenic) with abnormal fat distribution (lipodystrophy). Glucocorticoids regulate the functions of adipose tissue (AT) targeting adipocyte differentiation as well as anabolic, catabolic and secretory pathways of the adipocyte. However, the mechanisms by which glucocorticoids differentially disrupt the development or metabolism of AT between deep and superficial deposits remain unknown. Among the main effectors of the glucocorticoid signaling pathway, 11 beta-hydroxysteroid deshydrogenase (11beta-HSD1) , that regenerate cortisol from cortisone, is likely a key step in the biological effect of glucocorticoids in AT. Identifying these mechanisms of action of glucocorticoids on different fat depots requires the comparison with fatty deposits derived from two types of control populations: 1/ normal weight individuals without inflammatory or metabolic disorder (controls1); 2/individuals obese matched for the level of insulin resistance (controls2).
Hypothesis: Excess glucocorticoids cause abnormal fat distribution via a direct effect on the various deposits of AT, leading secondarily to insulin resistance.
Primary endpoint: To compare gene expression of glucocorticoid signaling between the visceral AT (VAT) of Cushing patients with that of controls1 (matched for age and sex).
Secondary endpoints:
For patients with Cushing and controls1, to compare their respective subcutaneous AT (SCAT) and VAT for:
- The expression of genes involved in differentiation and inflammation of the AT,
- Morphological aspects: adipocyte size, fibrosis, inflammation, immunohistochemistry.
- Same parameters for Cushing patients and controls2 (matched for sex, age + / -5, HOMA-R + / -1), to differentiate the specific effects of glucocorticoid from the effects of insulin resistance,
- To compare these parameters between SCAT and VAT from Cushing patients. Methodology and experimental design: non-randomized comparative multicenter study with constitution of a biological collection.
Patients will be recruited in endocrinology before adrenalectomy and controls1 in urology. They will have a preoperative assessment and sampling of perirenal AT and SCAT at surgery. Controls2 are already included in the CRC2007-P050318 and will be drawn for matching.
Number of patients needed: We assume the relative gene expression of 11β-HSD1 in the VAT not exposed to glucocorticoids = 0.81 ± 0.121. Our recruitment potential of Cushing patients is 30 patients. With 30 patients per group, we will be able to detect a difference in 11β-HSD1 gene expression in the VAT of Cushing patients at least 15% higher compared to controls1.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Paris, Francie, 75012
- Hôpital Saint-Antoine, service d'Endocrinologie
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Cases: Adults with Cushing's syndrome secondary to adrenal adenoma.
- Controls1: Adults with normal weight: BMI <25, having partial nephrectomy
- Controls2 adults with common obesity treated by bariatric surgery, BMI> 35kg/m2
Exclusion Criteria:
- Diabetes, renal or hepatic impairment, pregnancy, menopause, HIV or HCV, Cushing's syndrome due to other causes than cortisol adenoma
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Cushing group
AT biopsy during partial nephrectomy
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The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be
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Jiný: Controls1
normal weight metabolic healthy patients having partial nephrectomy with small AT Biopsy.
|
The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be
|
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Jiný: Controls2
obese individuals already included and having biopsies of VAT and SCAT stocked.
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The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Comparison between visceral adipose tissue of Cushing patients and that of normal weight controls.
Časové okno: 1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
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Comparison of glucocorticoid pathway genes expression between visceral adipose tissue of Cushing patients and that of normal weight controls matched on sex and age.
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1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Comparison of the respective SCAT and VAT between Cushing patients and normal weight controls.
Časové okno: 1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
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For patients with Cushing and controls1, to compare their respective SCAT and VAT for:
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1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
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Comparison of the respective SCAT and VAT between Cushing patients and obese controls.
Časové okno: 1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
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Comparison of these same parameters(secondary outcome n°1) between Cushing patients and controls2 (matched for sex, age + / -5, HOMA-R + / -1), to differentiate the specific effects of glucocorticoid from the effects of insulin resistance
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1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
|
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comparison between SCAT and VAT from Cushing patients
Časové okno: 1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
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To compare these parameters between SCAT and VAT from Cushing patients
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1 day (gene expression will be tested on AT withdraw the day of surgical adrenalectomy)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Bruno Feve, PhD, Assistance Publique
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Patologické procesy
- Novotvary podle histologického typu
- Novotvary
- Novotvary, žlázové a epiteliální
- Onemocnění endokrinního systému
- Choroba
- Adrenokortikální hyperfunkce
- Onemocnění nadledvinek
- Syndrom
- Adenom
- Cushingův syndrom
- Fyziologické účinky léků
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Glukokortikoidy
Další identifikační čísla studie
- P110906
- CRC11001 (Jiný identifikátor: Assistance Publique)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Cushing Syndrome Related to Cortisolic Adenoma
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University of LeedsDokončenoNadledvinky; Insuficience indukovaná glukortikoidy | Cushing; Syndrom nebo onemocnění indukované glukokortikoidy
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Sparrow PharmaceuticalsDokončenoAutonomní sekrece kortizolu (ACS) | ACTH-nezávislý Cushingův syndrom | ACTH-nezávislý adrenální cushing syndrom, somatickýSpojené státy, Rumunsko, Spojené království
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University Hospital, ToulouseDokončenoPrimární aldosteronismus | Adrenální adenomFrancie
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Zhe MengNáborPrimární aldosteronismus | Cushingův syndrom | Nefunkční adenom kůry nadledvinČína
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Haukeland University HospitalNáborPrimární aldosteronismus | Hyperkortizolismus | Adenom produkující aldosteronNorsko
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National Institute of Diabetes and Digestive and...DokončenoZollinger Ellisonův syndrom | Adenom ostrůvkových buněkSpojené státy
-
Icahn School of Medicine at Mount SinaiAbbVieUkončenoMírný nadbytek autonomního kortizoluSpojené státy
-
National Institute of Diabetes and Digestive and...DokončenoMetastáza novotvaru | Zollinger Ellisonův syndrom | Adenom ostrůvkových buněkSpojené státy
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Novartis PharmaceuticalsDokončenoCushingův syndrom | Ektopický kortikotropinový syndrom | Adrenální adenom | Karcinom nadledvin | AIMAH | PPNADJaponsko
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Imperial College LondonUniversity of CambridgeZatím nenabírámeAdenom hypofýzy | Cushingova nemoc | Hyperkortizolismus | Hypofýza ACTH vylučující adenom