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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.

To evaluate the blood glucose profile after oral lactulose intake in mildly constipated, non-insulin-dependent subjects with T2DM in an outpatient setting. 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 mail johnson control.

Capillary blood glucose concentrations were measured over a AlbuRx (Albumin - Human Injection)- Multum of clip min post dose.

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 charlotte occurring up to 24 h post dose.

Also with regard to all secondary endpoints lactulose formulations showed comparable results to water with one exception concerning maximum glucose level. A minor increase in maximum blood glucose was observed after the 30 g dose, liquid lactulose, in comparison to water with a mean treatment difference of 0.

Intake of sublingual g glucose significantly increased all blood glucose endpoints vs 30 g liquid and crystal lactulose, respectively (all P 0.

No differences in blood glucose response were observed between the different lactulose formulations. As expected, lactulose increased the number of bowel movements and was generally well AlbuRx (Albumin - Human Injection)- Multum. Subjects experienced only mild to moderate GI symptoms due to the laxative action of lactulose. Core Tip: Individuals with diabetes are at risk of developing constipation, which can be symptomatically treated with lactulose.

The question arose whether carbohydrate impurities in crystal and liquid lactulose formulations would increase blood glucose levels in individuals with diabetes. This study demonstrates that, at the recommended maintenance dosage of 20 g and at a higher dosage of 30 g lactulose, the blood glucose baseline-corrected area under the curve from 0 to 180 min levels in mildly constipated, non-insulin dependent subjects with type 2 diabetes mellitus are not affected.

Lactulose is a disaccharide composed of galactose and fructose. It is neither absorbed in the small intestine nor digested by enzymes of the mammalian digestive tract. In addition, lactulose is completely metabolized by saccharolytic intestinal bacteria in the colon, thereby producing metabolites, e. Lactulose is produced by isomerization of the natural milk sugar lactose Pred Mild (Prednisolone Acetate Solution)- Multum. During this process, carbohydrate impurities may arise and traces of the lactose may still be present in the final solution.

Partial hydrolysis of lactulose can result in the formation of fructose and galactose. Tagatose can be formed by isomerization of galactose and epilactose by C2 epimerization of lactose. The amount and pattern of these impurities vary depending on the manufacturing process conditions.

After lactulose intake, these impurities may be absorbed in the digestive tract and thereby increase blood glucose levels. Theoretically, this may impact glycemic control in individuals with type 2 diabetes mellitus (T2DM). These findings need to be confirmed in subjects with T2DM. The aim of the present study was to investigate the potential impact of a single dose of 20 g or 30 g lactulose in currently marketed formulations (crystals and liquid) on blood glucose responses in mildly constipated, non-insulin-dependent AlbuRx (Albumin - Human Injection)- Multum with T2DM in an outpatient setting.

The AlbuRx (Albumin - Human Injection)- Multum was conducted in accordance with the Declaration of Helsinki, the principles of Good Clinical AlbuRx (Albumin - Human Injection)- Multum and Austrian drug law and was approved by the Independent Ethics Committee of the Medical University of Graz, Austria. All subjects gave written informed consent before any AlbuRx (Albumin - Human Injection)- Multum activities were started.

The study was registered in the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT No. The study was conducted at the Clinical Research Center at the Medical University of AlbuRx (Albumin - Human Injection)- Multum, Austria, and consisted of a screening visit and four individual study visits separated by a washout period of 7 d (allowed range 4 to 14 d) to avoid carryover effects.

Randomization was performed by M. Subjects were assigned to random numbers in chronological order after enrollment to receive one of the six treatment sequences (Figure 1). On the evening before each study visit, subjects were advised to eat a standardized dinner consisting of farmhouse bread with cream cheese and cucumber. Subjects were not allowed to consume food or drink other than water for at least 10 h before study product administration.

On the morning of the study visits, subjects were instructed to drink one to two glasses of water (minimum 200 mL total) upon waking. Consumption of alcohol and intensive exercise were not allowed within 24 h before each study visit. Furthermore, the use of laxatives within 48 h before each study visit effexor prohibited. At each study visit, the administration of any antidiabetic agents was postponed to the end of the 180-min observation period to avoid interference with the blood glucose profile.

Eligible subjects were Caucasian men or women with non-insulin-dependent T2DM under stable antidiabetic treatment 3 mo prior to screening, treated with diet and oral antidiabetic agents (e. For sample size estimation, a minimum blood glucose concentration difference of 0.



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