Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH

Meir Mizrahi,1 Yehudit Shabat,1 Ami Ben Ya'acov,1 Gadi Lalazar,1 Tomer Adar,1 Victor Wong,2 Brian Muller,2 Grant Rawlin,2 Yaron Ilan11Liver Unit, Hebrew University-Hadassah Medical Center, Jerusalem, Israel; 2Immuron Limited, North Melbourne, AustraliaBackground: Nonalcoholic steatohepat...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Mizrahi M, Shabat Y, Ben Ya'acov A, Lalazar G, Adar T, Wong V, Muller B, Rawlin G, Ilan Y
Formato: article
Lenguaje:EN
Publicado: Dove Medical Press 2012
Materias:
Acceso en línea:https://doaj.org/article/211bfbfe93e74e8988ccc04d338fdf1f
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:211bfbfe93e74e8988ccc04d338fdf1f
record_format dspace
spelling oai:doaj.org-article:211bfbfe93e74e8988ccc04d338fdf1f2021-12-02T01:33:40ZAlleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH1178-7031https://doaj.org/article/211bfbfe93e74e8988ccc04d338fdf1f2012-12-01T00:00:00Zhttp://www.dovepress.com/alleviation-of-insulin-resistance-and-liver-damage-by-oral-administrat-a11793https://doaj.org/toc/1178-7031Meir Mizrahi,1 Yehudit Shabat,1 Ami Ben Ya'acov,1 Gadi Lalazar,1 Tomer Adar,1 Victor Wong,2 Brian Muller,2 Grant Rawlin,2 Yaron Ilan11Liver Unit, Hebrew University-Hadassah Medical Center, Jerusalem, Israel; 2Immuron Limited, North Melbourne, AustraliaBackground: Nonalcoholic steatohepatitis (NASH) is considered to be part of the nonalcoholic fatty liver disorders and its incidence is increasing. Imm124-E (Immuron Ltd, Melbourne, Australia), containing hyperimmune bovine colostrum, has been shown to exert an immunomodulatory effect and to alleviate target organ damage in animal models of NASH. The aim of our study was to determine the safety and efficacy of oral administration of Imm124-E to patients with insulin resistance and NASH.Methods: In an open-label trial, ten patients with biopsy-proven NASH and insulin resistance were orally treated with Imm124-E for 30 days.Results: Oral administration of Imm124-E was safe, and no side effects were noted. Alleviation of insulin resistance was reflected by significantly improved hemoglobin A1c (HbA1c) values in all ten treated patients. For between five and eight responders, the following effects were noted: a decrease in fasting glucose levels; improved oral glucose tolerance test (OGGT) and homeostatic model assessment insulin resistance (HOMA) scores; and alleviation in lipid profile. These effects were accompanied by increased serum levels of glucagon-like peptide 1 (GLP-1), adiponectin and T regulatory cells.Conclusion: Hyperimmune colostrum alleviates NASH.Keywords: NASH, anti-LPS, diabetes, adipokines, regulatory T cellsMizrahi MShabat YBen Ya'acov ALalazar GAdar TWong VMuller BRawlin GIlan YDove Medical PressarticlePathologyRB1-214Therapeutics. PharmacologyRM1-950ENJournal of Inflammation Research, Vol 2012, Iss default, Pp 141-150 (2012)
institution DOAJ
collection DOAJ
language EN
topic Pathology
RB1-214
Therapeutics. Pharmacology
RM1-950
spellingShingle Pathology
RB1-214
Therapeutics. Pharmacology
RM1-950
Mizrahi M
Shabat Y
Ben Ya'acov A
Lalazar G
Adar T
Wong V
Muller B
Rawlin G
Ilan Y
Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH
description Meir Mizrahi,1 Yehudit Shabat,1 Ami Ben Ya'acov,1 Gadi Lalazar,1 Tomer Adar,1 Victor Wong,2 Brian Muller,2 Grant Rawlin,2 Yaron Ilan11Liver Unit, Hebrew University-Hadassah Medical Center, Jerusalem, Israel; 2Immuron Limited, North Melbourne, AustraliaBackground: Nonalcoholic steatohepatitis (NASH) is considered to be part of the nonalcoholic fatty liver disorders and its incidence is increasing. Imm124-E (Immuron Ltd, Melbourne, Australia), containing hyperimmune bovine colostrum, has been shown to exert an immunomodulatory effect and to alleviate target organ damage in animal models of NASH. The aim of our study was to determine the safety and efficacy of oral administration of Imm124-E to patients with insulin resistance and NASH.Methods: In an open-label trial, ten patients with biopsy-proven NASH and insulin resistance were orally treated with Imm124-E for 30 days.Results: Oral administration of Imm124-E was safe, and no side effects were noted. Alleviation of insulin resistance was reflected by significantly improved hemoglobin A1c (HbA1c) values in all ten treated patients. For between five and eight responders, the following effects were noted: a decrease in fasting glucose levels; improved oral glucose tolerance test (OGGT) and homeostatic model assessment insulin resistance (HOMA) scores; and alleviation in lipid profile. These effects were accompanied by increased serum levels of glucagon-like peptide 1 (GLP-1), adiponectin and T regulatory cells.Conclusion: Hyperimmune colostrum alleviates NASH.Keywords: NASH, anti-LPS, diabetes, adipokines, regulatory T cells
format article
author Mizrahi M
Shabat Y
Ben Ya'acov A
Lalazar G
Adar T
Wong V
Muller B
Rawlin G
Ilan Y
author_facet Mizrahi M
Shabat Y
Ben Ya'acov A
Lalazar G
Adar T
Wong V
Muller B
Rawlin G
Ilan Y
author_sort Mizrahi M
title Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH
title_short Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH
title_full Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH
title_fullStr Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH
title_full_unstemmed Alleviation of insulin resistance and liver damage by oral administration of Imm124-E is mediated by increased Tregs and associated with increased serum GLP-1 and adiponectin: results of a phase I/II clinical trial in NASH
title_sort alleviation of insulin resistance and liver damage by oral administration of imm124-e is mediated by increased tregs and associated with increased serum glp-1 and adiponectin: results of a phase i/ii clinical trial in nash
publisher Dove Medical Press
publishDate 2012
url https://doaj.org/article/211bfbfe93e74e8988ccc04d338fdf1f
work_keys_str_mv AT mizrahim alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT shabaty alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT benyaamp39acova alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT lalazarg alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT adart alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT wongv alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT mullerb alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT rawling alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
AT ilany alleviationofinsulinresistanceandliverdamagebyoraladministrationofimm124eismediatedbyincreasedtregsandassociatedwithincreasedserumglp1andadiponectinresultsofaphaseiiiclinicaltrialinnash
_version_ 1718403004279816192