{"id":39586,"date":"2024-07-17T12:17:27","date_gmt":"2024-07-17T12:17:27","guid":{"rendered":"https:\/\/ibima.eu\/?p=39586"},"modified":"2024-07-24T13:33:42","modified_gmt":"2024-07-24T13:33:42","slug":"e-predice","status":"publish","type":"post","link":"https:\/\/ibima.eu\/es\/e-predice\/","title":{"rendered":"E-PREDICE"},"content":{"rendered":"<p>[et_pb_section fb_built=\u00bb1&#8243; _builder_version=\u00bb4.25.0&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_row _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbEarly Prevention of Diabetes Complications in people with Hyperglycaemia in Europe\u00bb _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_align=\u00bbcenter\u00bb title_text_color=\u00bb#0C71C3&#8243; module_alignment=\u00bbcenter\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=\u00bb2_3,1_3&#8243; _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb custom_padding=\u00bb30px||||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb2_3&#8243; _builder_version=\u00bb4.25.0&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_text _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a741fef elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a741fef\" data-element_type=\"section\">\n<div class=\"elementor-container elementor-column-gap-default\">\n<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-f9afe9b\" data-id=\"f9afe9b\" data-element_type=\"column\">\n<div class=\"elementor-widget-wrap elementor-element-populated\">\n<div class=\"elementor-element elementor-element-12113c9 elementor-widget elementor-widget-text-editor\" data-id=\"12113c9\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n<div class=\"elementor-widget-container\">\n<p><span style=\"color: #000000;\"><strong>Financed by<\/strong>: European Comission<\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Programme<\/strong>: HEALTH.2011.2.4.3-1 \u2013 Investigator-driven clinical trials to reduce diabetes complications<\/span><\/p>\n<p><span><b><span style=\"color: #000000;\">Grant Agreement ID:<\/span>\u00a0<\/b><a href=\"cordis.europa.eu\/project\/id\/279074\/reporting\">279074\u00a0<\/a><\/span><\/p>\n<p><span style=\"color: #000000;\"><strong>Rol in the project:\u00a0<\/strong>Partner<\/span><\/p>\n<p><span style=\"color: #000000;\"><b>Duration:\u00a0<\/b>January 2012 to December 2017<\/span><\/p>\n<p><span><\/span><\/p>\n<p><span><\/span><\/p>\n<p><span style=\"color: #000000;\">Contact:\u00a0G\u00f3mez Huelgas, Ricardo<\/span><\/p>\n<p><span><span style=\"color: #000000;\">Implementation Centre<strong>:<\/strong><\/span>\u00a0<a href=\"http:\/\/www.hospitalregionaldemalaga.es\/\">Hospital\u00a0Regional Universitario de M\u00e1laga<\/a><\/span><\/p>\n<p><span><span style=\"color: #000000;\">Research group of IBIMA involved:<\/span>\u00a0<a href=\"https:\/\/ibima.eu\/es\/project\/a-06\/\">Diabetes, Obesity and other Vascular Risk Factors. Systemic Autoimmune Diseases<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=\u00bb1_3&#8243; _builder_version=\u00bb4.25.0&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_post_title title=\u00bboff\u00bb meta=\u00bboff\u00bb image_height=\u00bb1000px\u00bb image_max_height=\u00bb234px\u00bb admin_label=\u00bbT\u00edtulo de publicaci\u00f3n\u00bb _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb title_font=\u00bbArial||||||||\u00bb title_text_align=\u00bbcenter\u00bb title_text_color=\u00bb#2ea3f2&#8243; title_font_size=\u00bb35px\u00bb meta_text_align=\u00bbcenter\u00bb background_enable_color=\u00bboff\u00bb background_enable_image=\u00bboff\u00bb text_orientation=\u00bbcenter\u00bb width=\u00bb100%\u00bb max_width=\u00bb100%\u00bb module_alignment=\u00bbcenter\u00bb min_height=\u00bb100px\u00bb height=\u00bb100px\u00bb max_height=\u00bb100px\u00bb custom_margin=\u00bb8%||1%||false|false\u00bb title_font_size_last_edited=\u00bboff|desktop\u00bb locked=\u00bboff\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_post_title][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb-9px||-57px||false|false\u00bb custom_padding=\u00bb50px||50px||true|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_column type=\u00bb4_4&#8243; _builder_version=\u00bb4.25.0&#8243; _module_preset=\u00bbdefault\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][et_pb_heading title=\u00bbABSTRACT\u00bb _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb title_font=\u00bb||||||||\u00bb title_text_color=\u00bb#0C71C3&#8243; global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb][\/et_pb_heading][et_pb_text _builder_version=\u00bb4.25.1&#8243; _module_preset=\u00bbdefault\u00bb custom_margin=\u00bb0px||19px||false|false\u00bb global_colors_info=\u00bb{}\u00bb theme_builder_area=\u00bbpost_content\u00bb]<\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Background: A significant proportion of pre-diabetics, show macro and micro vascular complications associated with hyperglycaemia. Although many trials have demonstrated the efficacy of lifestyle and pharmaceutical interventions in diabetes prevention, no trial has evaluated the extent to which mid- and long-term complications can be prevented by early interventions on hyperglycaemia.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Aims: To assess the long-term effects on multiple complications of hyperglycaemia of early intensive management of hyperglycaemia with linagliptin, metformin or their combination added to lifestyle intervention (LSI) (diet and physical activity), compared with LSI alone in adults with non-diabetic intermediate hyperglycaemia (IFG, IGT or both).<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Study Design: Investigator initiated (non-commercial), long-term, multi-centre, randomised, partially double blinded, placebo controlled, phase-IIIb clinical trial with prospective blinded outcome evaluation. Participants will be randomised to four parallel arms: 1) LSI + 2 placebo tablets\/day; 2) LSI + 2 Metformin tablets of 850 mg\/day; 3) LSI + 1 Linagliptin tablets of 5 mg\/day and 1 placebo; 4) LSI + 2 tablets of a fixed-dose combination of Linagliptin 2.5mg and Metformin 850 \/day. Active intervention will last for at least 2 years, and additional follow-up up to 4 years.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Setting and population: Males and Females with pre-diabetes (IFG, IGT or both) aged 45 to 74 years selected from primary care screening programs in 15 clinical centres from 12 countries. (N=2000).<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Main Outcomes: The primary endpoint is a combined continuous variable: \u201cthe microvascular complication \u00edndex\u201d\u201d\u201d\u201d (MCI) composed by a linear combination of the Early Treatment Diabetic Retinopathy Study Scale (ETDRS) score (based on retinograms), the level of urinary albumin to creatinine ratio, and a measure of distal small fibre neuropathy (sudomotor test by SUDOSCAN), measured during baseline visit and at 24th and 48th month visits after randomisation. In addition, this project will include the evaluation of early novel serological biomarkers of systemic inflammation, early micro-vascular damage, non-alcoholic fatty liver disease, insulin sensitivity and insulin secretion, and measures of quality of life, sleep quality (somnograms) and neuropsychological evaluation. Vascular function and structure will be evaluated in a subset of participants (n=1000), including cIMT and microvascular endothelial function measured by EndoPAT.<\/span><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #000000;\">Results: By evaluating the effect of aggressive treatments in pre-diabetes for the early prevention of diabetes complication, this project has the potential of changing the current paradigm of early management of hyperglycaemia. The ultimate goal is the development of a standardized core protocol for the early prevention of microvascular and other complications, impacting social cost as a result not only in health care, but also in disabilities at work.<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Financed by: European Comission Programme: HEALTH.2011.2.4.3-1 \u2013 Investigator-driven clinical trials to reduce diabetes complications Grant Agreement ID:\u00a0279074\u00a0 Rol in the project:\u00a0Partner Duration:\u00a0January 2012 to December 2017 Contact:\u00a0G\u00f3mez Huelgas, Ricardo Implementation Centre:\u00a0Hospital\u00a0Regional Universitario de M\u00e1laga Research group of IBIMA involved:\u00a0Diabetes, Obesity and other Vascular Risk Factors. Systemic Autoimmune Diseases Background: A significant proportion of pre-diabetics, show [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":39592,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[2191],"tags":[],"class_list":["post-39586","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-proyectos-de-investigacion"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>E-PREDICE - Ibima<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ibima.eu\/es\/e-predice\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"E-PREDICE - Ibima\" \/>\n<meta property=\"og:description\" content=\"Financed by: European Comission Programme: HEALTH.2011.2.4.3-1 \u2013 Investigator-driven clinical trials to reduce diabetes complications Grant Agreement ID:\u00a0279074\u00a0 Rol in the project:\u00a0Partner Duration:\u00a0January 2012 to December 2017 Contact:\u00a0G\u00f3mez Huelgas, Ricardo Implementation Centre:\u00a0Hospital\u00a0Regional Universitario de M\u00e1laga Research group of IBIMA involved:\u00a0Diabetes, Obesity and other Vascular Risk Factors. 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