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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04328259
Other study ID # NAFLD in patient of IBD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date April 1, 2022

Study information

Verified date May 2020
Source Assiut University
Contact Shymaa A Ahmed, Resident
Phone 01065023156
Email Shymaaabdelhakam8989@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To assess the prevalance of non_alcoholic fatty liver diseases in inflammatory bowel disease patients and its relation to type of treatment given and disease severity


Description:

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date April 1, 2022
Est. primary completion date October 1, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (16)

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. — View Citation

Calzadilla Bertot L, Adams LA. The Natural Course of Non-Alcoholic Fatty Liver Disease. Int J Mol Sci. 2016 May 20;17(5). pii: E774. doi: 10.3390/ijms17050774. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Gomollón 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. — View Citation

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, Zagórowicz 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary the prevalance of non-alcoholic fatty liver in inflammatory bowel disease participants 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
Secondary the Correlation between immunosuppressive drugs and prevalance of non-alcoholic fatty liver affection in inflammatory bowel disease participants one year