The objective of the study is to investigate whether lactulose, given orally as powder or liquid, increases blood glucose levels in patients with diabetes mellitus type 2. The dose of lactulose given in the study is normally used for treatment of constipation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
24
White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.
White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.
Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
Clinical Research Center (CRC)
Graz, Austria
Capillary blood glucose levels as baseline corrected AUC: AUCbaseline_c (0-180 minutes) [Baseline corrected area under curve from 0 to 180 minutes for blood glucose concentration (= Area under curve from 0 to 180 minutes minus baseline*180 minutes)]
Time frame: 0 - 180 minutes, during 4 study visits
Maximum blood glucose concentration (Cmax)
Time frame: 0 - 180 minutes, during 4 study visits
Maximum increase of blood glucose concentration (Max_increase)
Time frame: 0 - 180 minutes, during 4 study visits
Relative maximum increase of blood glucose concentration (Max_increase_rel)
Time frame: 0 - 180 minutes, during 4 study visits
Time to reach maximum blood glucose concentration (Tmax)
Time frame: 0 - 180 minutes, during 4 study visits
Total area under curve from 0 to 180 minutes for blood glucose concentration (AUC(0-180 minutes))
Time frame: 0 - 180 minutes, during 4 study visits
Incremental area under curve from 0 to 180 minutes for blood glucose concentration, i.e., above baseline levels for blood glucose concentration after oral intake of Laevolac crystals/liquid or control products (iAUC(0-180min))
Time frame: 0 - 180 minutes, during 4 study visits
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Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
White crystalline powder. To standardise for 30 g glucose, 33 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products