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

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 

机构地区：[1]Division of Endocrinology and Diabetology,Department of Internal Medicine,Medical University of Graz,Graz 8036,Austria [2]Department of Statistic,M.A.R.C.O.GmbH&Co.KG,Institute for Clinical Research and Statistics,Düsseldorf 40211,Germany [3]Department of Nutritional CRO,BioTeSys GmbH,Esslingen 73728,Germany [4]Department of Medical&Clinical Affairs,Market Access&Education Business Unit Enteral Nutrition,Bad Homburg 61352,Germany [5]Department of Medical,Clinical&Regulatory Affairs,Business Unit Parenteral Nutrition,Keto-Analogues and Standard I.V.Fluids,Fresenius Kabi Deutschland GmbH,Bad Homburg 61352,Germany [6]Department of Consultancy,Stover-Solutions,Zurich 8006,Switzerland [7]Market Unit Lactulose,Fresenius Kabi Austria GmbH,Linz 4020,Austria

出　　处：《World Journal of Diabetes》2021年第6期893-907,共15页世界糖尿病杂志（英文版）（电子版）

摘　　要：BACKGROUND Lactulose is approved for the symptomatic treatment of constipation,a gastrointestinal(GI)complication common in individuals with diabetes.Lactulose products contain carbohydrate impurities(e.g.,lactose,fructose,galactose),which occur during the lactulose manufacturing process.These 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 intake.However,it is still unclear whether the intake of lactulose increases blood glucose levels in individuals with diabetes.AIM To evaluate the blood glucose profile after oral lactulose intake in mildly constipated,non-insulin-dependent subjects with T2DM in an outpatient setting.METHODS 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 T2DM.Eligible subjects were randomized and assigned to one of six treatment sequences,each consisting of four treatments stratified by sex using an incomplete block design.Subjects 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 control.Capillary blood glucose concentrations were measured over a period of 180 min post dose.The 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 lactulose.Safety parameters included GI tolerability,which was assessed at 180 min and 24 h post dose,and adverse events occurring up to 24 h post dose.In 24 randomized and analyzed subjects blood glucose concentrati

关 键 词：LACTULOSE CONSTIPATION Blood glucose Type 2 diabetes mellitus LAXATIVE Sugar substitute 

分 类 号：R587.1[医药卫生—内分泌]