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Blood glucose response after oral lactulose intake in type 2 diabetic individuals

World Journal of Diabetes 2021年第6期12卷 893-907页

作者： Thomas R Pieber Eva Svehlikova ines mursic Tamara Esterl Manfred Wargenau Tina Sartorius Lioba Pauly Susann Schwejda-Guettes Annalena Neumann Valentin Faerber John Friedrich Stover Barbara Gaigg Angelika Kuchinka-Koch Division of Endocrinology and Diabetology Department of Internal MedicineMedical University of GrazGraz 8036Austria Department of Statistic M.A.R.C.O.GmbH&Co.KGInstitute for Clinical Research and StatisticsDüsseldorf 40211Germany Department of Nutritional CRO BioTeSys GmbHEsslingen 73728Germany Department of Medical&Clinical Affairs Market Access&Education Business Unit Enteral NutritionBad Homburg 61352Germany Department of Medical Clinical&Regulatory AffairsBusiness Unit Parenteral NutritionKeto-Analogues and Standard I.V.FluidsFresenius Kabi Deutschland GmbHBad Homburg 61352Germany Department of Consultancy Stover-SolutionsZurich 8006Switzerland Market Unit Lactulose Fresenius Kabi Austria GmbHLinz 4020Austria

BACKGROUND Lactulose is approved for the symptomatic treatment of constipation,a gastrointestinal(GI)complication common in individuals with *** products contain carbohydrate impurities(e.g.,lactose,fructose,galactose),which occur during the lactulose manufacturing *** impurities may affect the blood glucose levels of individuals with type 2 diabetes mellitus(T2DM)using lactulose for the treatment of mild constipation.A previous study in healthy subjects revealed no increase in blood glucose levels after oral lactulose ***,it is still unclear whether the intake of lactulose increases blood glucose levels in individuals with *** To evaluate the blood glucose profile after oral lactulose intake in mildly constipated,non-insulin-dependent subjects with T2DM in an outpatient *** This prospective,double-blind,randomized,controlled,single-center trial was conducted at the Clinical Research Center at the Medical University of Graz,Austria,in 24 adult Caucasian mildly constipated,non-insulin-dependent subjects with *** subjects were randomized and assigned to one of six treatment sequences,each consisting of four treatments stratified by sex using an incomplete block *** received a single dose of 20 g or 30 g lactulose(crystal and liquid formulation),water as negative control or 30 g glucose as positive *** blood glucose concentrations were measured over a period of 180 min post *** primary endpoint was the baseline-corrected area under the curve of blood glucose concentrations over the complete assessment period[AUC_(baseline_c(0-180 min))].Quantitative comparisons were performed for both lactulose doses and formulations vs water for the equal lactulose dose vs glucose,as well as for liquid lactulose vs crystal *** parameters included GI tolerability,which was assessed at 180 min and 24 h post dose,and adverse events occurring up to 24 h post *** 24 randomized

关键词： Lactulose Constipation Blood glucose Type 2 diabetes mellitus Laxative Sugar substitute

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