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Blood glucose response after oral intake of lactulose in healthy volunteers:A randomized,controlled,cross-over study

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World Journal of Gastrointestinal Pharmacology and Therapeutics 2018年第3期9卷 22-30页

作者： Jasmin Steudle Christiane Schon Manfred Wargenau Lioba Pauly Susann Schwejda-Güttes Barbara Gaigg Angelika Kuchinka-Koch John F Stover BioTeSys gmbh Esslingen 73728Germany M.A.R.C.O.gmbh and Co.KG Institute for Clinical Research and StatisticsDüsseldorf 40211Germany fresenius kabi deutschland gmbh Oberursel 61440Germany fresenius kabi Austria gmbh Linz 4020Austria

AIM To investigate possible changes of blood glucose levels after oral intake of lactulose in healthy *** The study was performed as prospective, randomized, two-part study with 4-way cross-over design with n = 12 in each study arm. Capillary blood glucose levels were determined over a time period of 180 min after intake of a single dose of 10 g or 20 g lactulose provided as crystal or liquid formulation. During the manufacturing process of lactulose, impurities with sugars(e.g., lactose, fructose, galactose) occur. Water and 20 g glucose were used as control and reference. Because lactulose is used as a functional food ingredient, it may also be consumed by people with impaired glucose tolerance, including diabetics. Therefore, it is of interest to determine whether the described carbohydrate impurities may increase blood glucose levels after ingestion. RESULTS The blood glucose concentration-time curves after intake of 10 g lactulose, 20 g lactulose, and water were almost identical. None of the three applications showed any changes in blood glucose levels. After intake of 20 g glucose, blood glucose concentration increased by approximately 3 mmol/L(mean Cmax = 8.3 mmol/L), reaching maximum levels after approximately 30 min and returning to baseline within approximately 90 min, which was significantly different to the corresponding 20 g lactulose formulations(P < 0.0001). Comparing the two lactulose formulations, crystals and liquid, in the dosage of 10 g and 20 g, there was no difference in the blood glucose profile and calculated pharmacokinetic parameters despite the different amounts of carbohydrate impurities(1.5% for crystals and 26.45% for liquid). Anyhow, the absolute amount of single sugars was low with 0.3 g in crystals and 5.29 g in liquid formulation in the 20 g dosages. Lactulose was well tolerated by most volunteers, and only some reported mild to moderate mainly gastrointestinal side effects. CONCLUSION The unchanged blood glucose levels

关键词： Lactulose Functional food ingredient Sugar substitute Blood glucose concentration

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Compliance and Tolerance of a New High Protein and High Energy Oral Nutritional Supplement in Older Adults

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Journal of Nutritional Oncology 2018年第3期3卷 120-129页

作者： Cornelius Koch Annika Dax Andre Warnke Lioba Pauly Stephanie Reichart Katharina S.Kuhn Ericka A Pestana John F Stover Konstantin Lekkos SocraTec R&D gmbh ErfurtGermany fresenius kabi deutschland gmbh Bad HomburgGermany Medical Writing StuttgartGermany Helios Klinikum HildesheimDepartment of GeriatricsGermany

Background and objectives Volume,caloric density,and timing of administration influence compliance to oral nutritional supplements(ONS).The provision of high energy,high protein and low volume ONS may allow easy achievement of intakes considered effective in improving nutritional *** report the evaluation of a new low volume,energy dense ONS in older *** and study design Two open-label studies,each including 20 older adults(75±4 and 76±5 years)in residential *** received one bottle(125 ml,400 kcal,20 g protein)of the new ONS daily,either as a single or multiple dose(3×40 ml/~400 kcal)for 7 *** outcome was gastrointestinal(GI)tolerance;additional parameters of interest were palatability and compliance(ratio of consumed *** volume).Data were evaluated *** All participants completed the studies and reported good *** symptoms were comparable before first and after last ingestion,55%and 65%(single and multiple dose regimens)did not report any GI *** consumed 96%and 94%of the prescribed volume,***,smell and appearance were rated as“good”or“excellent”on both days of recording(day 1 and day 7)by 75-90%of the participants in both *** A high energy,high protein ONS delivered in a small volume was well tolerated and accepted in older adults,with excellent compliance,independent of the delivery as single or multiple ***,this new ONS represents a clinically valuable option for high compliance to nutritional therapy.

关键词： Compliance Elderly Palatability Tolerance

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

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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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Adsorption/Desorption of Low-density Lipoprotein on a Heparinized Surface of Gold Sensors

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Chemical Research in Chinese Universities 2012年第2期28卷 323-328页

作者： LAN Ping JI Jing HUANG Xiao-Jun GUDURU Deepak GROTH Thomas VIENKEN Jorg D1NG Hui College of Materials and Textiles Jiaxing UniversityJiaxing 314001P.R.China Key Laboratory of Macromolecular Synthesis and Functionalization Ministry of EducationDepartment of Polymer Science and EngineeringZhejiang UniversityHangzhou 310027P.R.China Biomedical Materials Group Department of Pharmaceutics and BiopharmaeeuticsInstitute of PharmacyMartin Luther University Halle-WittenbergHalle(Saale)06120Germany fresenius Medical Care of deutschland gmbh BioSciences DepartmentBad Homburg 61352Germany College of Mathematics Physics and Information Engineering Jiaxing UniversityJiaxing 314001P.R.China

Heparin has been considered to be a potentially useful ligand for low-density lipoprotein（LDL） detection and analysis in a clinical *** order to construct an affinity surface for preferential adsorption of LDL,heparin-modified gold surface（GS-Hep） was fabricated by a self-assembling method and hydrophobic-modified gold surfaces（GS-Hydro） was used as a *** morphologies of the modified gold surfaces were investigated by atomic force microscopy（AFM） and the quantity of heparin bound to gold surface was assayed by the toluidine blue（TB） colorimetric *** contact angles were determined to investigate wettability on GS-Hep and *** plasmon resonance（SPR） technique was used subsequently to detect the selective binding of LDL with *** the investigation on the effect of pH on LDL adsorption suggests that lower pH lead to higher quantities of LDL adsorption on *** with GS-Hydro,GS-Hep is selective for LDL from both single and binary protein ***,adsorbed LDL on GS-Hep could be washed off by injecting elution solution,such as NaCl solution,for the purpose of the regeneration of GS-Hep for further LDL adsorption.

关键词： Adsorption/desorption Low-density lipoprotein(LDL) Heparinized surface Surface plasmon resonance

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The Volume Effect and Safety of 6% Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery: An Uncontrolled, Open-Labeled, Multi-Center Study

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Open Journal of Anesthesiology 2013年第7期3卷 326-337页

作者： Nobutada Morioka Makoto Ozaki Michiaki Yamakage Hiroshi Morimatsu Yasuyuki Suzuki Frank Bepperling Hideki Miyao Akiyoshi Namiki Kiyoshi Morita Department of Anesthesia and Intensive Care Medicine National Center for Child Health and Development Tokyo Japan Department of Anesthesiology Okayama University Okayama Japan Department of Anesthesiology Saitama Medical Center Saitama Medical University Kawagoe Japan Department of Anesthesiology Sapporo Medical University School of Medicine Sapporo Japan Department of Anesthesiology Tokyo Women’s Medical University Tokyo Japan fresenius kabi deutschland gmbh Bad Homburg Germany Otaru City Hospitals Otaru-shi Japan.

Purpose: The primary aim of this study was to investigate volume effect and safety of up to 50 mL/kg BW 6% hydroxyethyl starch (HES) 130/0.4 in adult and pediatric patients undergoing major elective surgery. The need to infuse human albumin may be reduced or avoided in Japan if these large doses 6% HES 130/0.4 can be infused. Methods: The study was an uncontrolled, open-labeled, multi-center trial. Fifteen adult and 5 pediatric patients undergoing major elective surgery received 6% HES 130/0.4 (Voluven®) with a maximum dose of 50 mL/kg from the start of surgery until 2 hours after the end of surgery according to a treatment algorithm. The primary efficacy endpoint was the volume effect of 6% HES 130/0.4 determined by the volume of saved albumin during the investigational period and the time course of hemodynamic stability in adult and pediatric patients. Safety parameters were fluid balance, hemodynamic and laboratory parameters ECG, local and systemic tolerance and adverse events. Results: Adult patients received a mean of 32.0 mL/kg of 6% HES 130/0.4. For 12 out of 15 adult patients an average amount of 1033.8 mL (18.6 mL/kg) albumin could be saved. The other 3 adult patients did not receive more than 1000 mL of HES 130/0.4. All pediatric patients received approximately 50 mL/kg of HES 130/0.4;for these patients an average amount of 39.9 mL/kg body weight albumin could be saved. The majority of adult patients, and all pediatric patients were hemodynamically stable at all 3 time points. The observed changes of the assessed laboratory parameters including hematological and coagulation parameters or in any other safety parameter determined did not reveal any safety concern related to the administration of 6% HES 130/0.4 up to doses of 50 mL/kg body weight. Conclusion: The study results indicate that 6% HES 130/0.4 has a reliable volume effect, could contribute to significant human albumin savings and was safe and well tolerated up to a maximum dose of 50 mL/kg bo

关键词： High Dose Volume Effect Safety 6% Hydroxyethyl Starch 130/0.4 Elective Surgery Multi-Center Study

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