- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04328259
Prevalance of non_ Alcoholic Fatty Liver Diseases in Patient With Inflammatory Bowel Diseases Attending Assiut University Hospitals
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Inflammatory bowel diseases (IBD) including Crohns disease (CD) and ulcerative colitis (UC) are chronic relapsing disorders that often require long-term therapy and follow up .
They are recognized for their complex pathophysiology that involves innate immune system deregulation and altered microbiome in genetically predisposed individuals. Non-alcoholic fatty liver disease (NAFLD) includes a wide spectrum of disorders, ranging from hepatic steatosis (NAFL) to non-alcoholic steatohepatitis (NASH). NAFLD patients are at high risk for liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Also NAFLD is typically associated with altered metabolism and metabolic syndrome (MetS).
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Crohn's disease (CD) patients
- ulcerative colitis (UC) patients
Exclusion Criteria:
- diabetic patients
- BMI equal and more than 30.0-34.9(class I obesity)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
the prevalance of non-alcoholic fatty liver in inflammatory bowel disease participants
Délai: one year
|
u/s will be done to all participants of inflammatory bowel disease to asses the rate of non-alcoholic fatty liver affection of all patients
|
one year
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
the Correlation between immunosuppressive drugs and prevalance of non-alcoholic fatty liver affection in inflammatory bowel disease participants
Délai: one year
|
one year
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.
- National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
- Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.
- Best WR, Becktel JM, Singleton JW, Kern F Jr. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology. 1976 Mar;70(3):439-44.
- European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
- Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.
- Satsangi J, Silverberg MS, Vermeire S, Colombel JF. The Montreal classification of inflammatory bowel disease: controversies, consensus, and implications. Gut. 2006 Jun;55(6):749-53. doi: 10.1136/gut.2005.082909.
- Torres J, Mehandru S, Colombel JF, Peyrin-Biroulet L. Crohn's disease. Lancet. 2017 Apr 29;389(10080):1741-1755. doi: 10.1016/S0140-6736(16)31711-1. Epub 2016 Dec 1.
- de Souza HS, Fiocchi C. Immunopathogenesis of IBD: current state of the art. Nat Rev Gastroenterol Hepatol. 2016 Jan;13(1):13-27. doi: 10.1038/nrgastro.2015.186. Epub 2015 Dec 2.
- Demir M, Lang S, Steffen HM. Nonalcoholic fatty liver disease - current status and future directions. J Dig Dis. 2015 Oct;16(10):541-57. doi: 10.1111/1751-2980.12291.
- Wong VW, Wong GL, Choi PC, Chan AW, Li MK, Chan HY, Chim AM, Yu J, Sung JJ, Chan HL. Disease progression of non-alcoholic fatty liver disease: a prospective study with paired liver biopsies at 3 years. Gut. 2010 Jul;59(7):969-74. doi: 10.1136/gut.2009.205088.
- Calzadilla Bertot L, Adams LA. The Natural Course of Non-Alcoholic Fatty Liver Disease. Int J Mol Sci. 2016 May 20;17(5):774. doi: 10.3390/ijms17050774.
- McPherson S, Hardy T, Henderson E, Burt AD, Day CP, Anstee QM. Evidence of NAFLD progression from steatosis to fibrosing-steatohepatitis using paired biopsies: implications for prognosis and clinical management. J Hepatol. 2015 May;62(5):1148-55. doi: 10.1016/j.jhep.2014.11.034. Epub 2014 Dec 1.
- Gomollon F, Dignass A, Annese V, Tilg H, Van Assche G, Lindsay JO, Peyrin-Biroulet L, Cullen GJ, Daperno M, Kucharzik T, Rieder F, Almer S, Armuzzi A, Harbord M, Langhorst J, Sans M, Chowers Y, Fiorino G, Juillerat P, Mantzaris GJ, Rizzello F, Vavricka S, Gionchetti P; ECCO. 3rd European Evidence-based Consensus on the Diagnosis and Management of Crohn's Disease 2016: Part 1: Diagnosis and Medical Management. J Crohns Colitis. 2017 Jan;11(1):3-25. doi: 10.1093/ecco-jcc/jjw168. Epub 2016 Sep 22.
- Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, Burisch J, Gecse KB, Hart AL, Hindryckx P, Langner C, Limdi JK, Pellino G, Zagorowicz E, Raine T, Harbord M, Rieder F; European Crohn's and Colitis Organisation [ECCO]. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders. J Crohns Colitis. 2017 Jun 1;11(6):649-670. doi: 10.1093/ecco-jcc/jjx008. No abstract available. Erratum In: J Crohns Colitis. 2022 Aug 16;:
- Saverymuttu SH, Joseph AE, Maxwell JD. Ultrasound scanning in the detection of hepatic fibrosis and steatosis. Br Med J (Clin Res Ed). 1986 Jan 4;292(6512):13-5. doi: 10.1136/bmj.292.6512.13.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles induits chimiquement
- Maladies du système digestif
- Troubles liés à l'alcool
- Troubles liés à une substance
- Maladies gastro-intestinales
- Gastro-entérite
- Maladies du foie, alcoolique
- Troubles induits par l'alcool
- Maladies du foie
- Maladies intestinales inflammatoires
- Foie gras
- Maladies intestinales
- Foie Gras, Alcoolique
Autres numéros d'identification d'étude
- NAFLD in patient of IBD
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .