Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
Efficacy of Phosphatidylcholine in Addition to Behavior Therapy by Clinical Pharmacist in the Management of Non Alcoholic Fatty Liver (NAFLD)
NCT number | NCT04411862 |
Other study ID # | NAFLD |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | January 2, 2016 |
Est. completion date | July 1, 2019 |
Verified date | June 2020 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates efficacy of Phosphatidylcholine in addition to life style modification and patient health education by clinical Pharmacist in the Management of Non Alcoholic Fatty Liver NAFLD. All participants with NAFLD will receive life style intervention and half of them will receive additionally Phosphatidylcholine.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 1, 2019 |
Est. primary completion date | January 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Patients were included in the study when the following criteria to were fulfilled : Inclusion Criteria: - fatty liver upon Ultrasonography (US) /Computed Tomography (CT) /Magnetic Resonance Imaging (MRI) with either incidental increased Alanine Aminotransferase (ALT) - the presence of risk factors related to NAFLD + increased ALT - symptomatic liver disease +/- hepatomegaly, +/- increased ALT - homeostasis model assessment-insulin resistance HOMA IR score > 3 - presence of liver steatosis or stiffness measured by transient elastography - eligible patients had at least one of the following metabolic comorbidities: hypertension, Type 2 Diabetes Mellitus, overweight/obesity (BMI>27 kg/m2) serum cholesterol of > 200 mg/d Patients were excluded from the study if showing evidence : Exclusion Criteria: - if showing evidence of alcoholic or chronic liver disease - Hepatocellular Carcinoma, autoimmune hepatitis - end stage liver disease - treatment with other hepatoprotectants - other concomitant EPL within 30 days of study initiation - pregnancy or lactation |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Nehal Abou Seada |
Ahmed MH, Noor SK, Bushara SO, Husain NE, Elmadhoun WM, Ginawi IA, Osman MM, Mahmoud AO, Almobarak AO. Non-Alcoholic Fatty Liver Disease in Africa and Middle East: An Attempt to Predict the Present and Future Implications on the Healthcare System. Gastroenterology Res. 2017 Oct;10(5):271-279. doi: 10.14740/gr913w. Epub 2017 Oct 26. Review. — View Citation
Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatol — View Citation
Chalasani N; Writing Group for American Association for Study of Liver Diseases; American College of Gastroenterology; American Gastroenterology Association practice guideline on Diagnosis and Management of Nonalcoholic Fatty Liver Disease. Reply: To PMID 22488764. Hepatology. 2013 Feb;57(2):853-4. doi: 10.1002/hep.26199. Epub 2013 Jan 7. — 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
Gundermann KJ, Gundermann S, Drozdzik M, Mohan Prasad VG. Essential phospholipids in fatty liver: a scientific update. Clin Exp Gastroenterol. 2016 May 5;9:105-17. doi: 10.2147/CEG.S96362. eCollection 2016. Review. — 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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from baseline Body Mass Index (BMI) at 3 and 6 month | person's weight in kilograms divided by the square of the person's height in metres (kg/m2). | baseline, at 3 and 6 month | |
Primary | change from baseline liver stiffness at 3 and 6 month | Liver Stiffness and fibrosis score measured by Transient elastography (Fibroscan) F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis | baseline , at 3 and 6 month | |
Primary | change from baseline Lipid Profile | Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein | baseline , at 3 and 6 month | |
Primary | change from baseline Oxidative stress markers | malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay | baseline , at 3 and 6 month | |
Primary | change from baseline NAFLD score at 3 and 6 month | NAFLD Fibrosis Score is based on six readily available variables (age, BMI, hyperglycemia, albumin, platelet count, AST/ALT ratio) and it is calculated using published formula (http: //naflds- core.com) . A low cutpoint (score < -1.455) signified the absence of advanced fibrosis, whereas a high cutpoint (score> 0.676) identified advanced fibrosis. | baseline , at 3 and 6 month | |
Primary | change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month | HOMA IR scores <3 normal HOMA IR scores >5 severe insulin resistance 3 to 5 moderate insulin resistance | baseline , at 3 and 6 month | |
Secondary | change from baseline Complete Blood Picture at 3 and 6 month | platelet count | baseline , at 3 and 6 month |
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