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

Table 1 Demographic and baseline data of subjects (n = 24)

Variable	mean	SD	Min	Median	Max
Age (yr)	62.2	7.61	45	62.5	73
BMI (kg/m2)	30.0	3.0	23.3	30.1	34.7
Systolic BP (mmHg)	142.8	19.1	114.0	141.5	196.0
Diastolic BP (mmHg)	88.1	9.1	73.0	90.0	105.0
HbA1c (%)	6.6	2.6	5.5	6.6	7.5

BMI: Body mass index; BP: Blood pressure; HbA_1c: Glycosylated hemoglobin; Max: Maximum; Min: Minimum, SD: Standard deviation.

Table 2 Blood glucose endpoints: 20 g crystal lactulose vs water

	20 g crystal lactulose		Water		Treatment	P value
Variable	n	LS mean (95%CI)	n	LS mean (95%CI)	Difference (95%CI)
AUCbaseline_c (0-180 min) (min/mmol/L)	16	-54.40 (-100.23, -8.57)	16	-53.21 (-99.14, -7.28)	-1.20 (-60.78, 58.39)	0.9682
AUC(0-180 min) (min/mmol/L)	16	1218.33 (1172.50, 1264.16)	16	1219.53 (1173.60, 1265.46)	-1.20 (-60.78, 58.39)	0.9682
iAUC(0-180 min) (min/mmol/L)	16	17.00 (-14.43, 48.43)	16	18.44 (-13.04, 49.92)	-1.44 (-45.16, 42.29)	0.9478
Cmax (mmol/L)	16	7.50 (7.17, 7.82)	16	7.44 (7.11, 7.77)	0.06 (-0.38, 0.50)	0.7999
Max_increase (mmol/L)	16	0.43 (0.10, 0.75)	16	0.37 (0.04, 0.70)	0.06 (-0.38, 0.50)	0.7999

AUC_{baseline_c (0-180 min)}: Baseline-corrected area under the curve from 0 to 180 min; AUC_{(0-180 min)}: Area under the curve from 0 to 180 min; iAUC_{(0-180 min)}: Incremental AUC_{(0-180 min)}, i.e., area above baseline levels of blood glucose concentration; C_max: Maximum blood glucose concentration; Max_increase: Maximum blood glucose concentration minus baseline value; LS mean: Adjusted least square mean obtained from analysis of covariance model.

Table 3 Blood glucose endpoints: 30 g crystal lactulose vs water

	30 g crystal lactulose		Water		Treatment	P value
Variable	n	LS mean (95%CI)	n	LS mean (95%CI)	Difference (95%CI)
AUCbaseline_c (0-180 min) (min/mmol/L)	16	-30.70 (-76.75, 15.35)	16	-53.21 (-99.14, -7.28)	22.51 (-37.05, 82.06)	0.4529
AUC(0-180 min) (min/mmol/L)	16	1242.03 (1195.98, 1288.08)	16	1219.53 (1173.60, 1265.46)	22.51 (-37.05, 82.06)	0.4529
iAUC(0-180 min) (min/mmol/L)	16	27.65 (-3.91, 59.21)	16	18.44 (-13.04, 49.92)	9.21 (-34.39, 52.81)	0.6744
Cmax (mmol/L)	16	7.77 (7.44, 8.09)	16	7.44 (7.11, 7.77)	0.33 (-0.11, 0.76)	0.1426
Max_increase (mmol/L)	16	0.70 (0.37, 1.02)	16	0.37 (0.04, 0.70)	0.33 (-0.11, 0.76)	0.1426

AUC_{baseline_c (0-180 min)}: Baseline-corrected area under the curve from 0 to 180 min; AUC_{(0-180 min)}: Area under the curve from 0 to 180 min; iAUC_{(0-180 min)}: Incremental AUC_{(0-180 min)}, i.e., area above baseline levels of blood glucose concentration; C_max: Maximum blood glucose concentration; Max_increase: Maximum blood glucose concentration minus baseline value; LS mean: Adjusted least square mean obtained from analysis of covariance model.

Table 4 Blood glucose endpoints: 20 g liquid lactulose vs water

	20 g liquid lactulose		Water		Treatment	P value
Variable	n	LS mean (95%CI)	n	LS mean (95%CI)	Difference (95%CI)
AUCbaseline_c (0-180 min) (min/mmol/L)	17	-30.72 (-75.26, 13.83)	16	-53.21 (-99.14, -7.28)	22.49 (-35.18, 80.16)	0.4387
AUC(0-180 min) (min/mmol/L)	17	1242.02 (1197.47, 1286.56)	16	1219.53 (1173.60, 1265.46)	22.49 (-35.18, 80.16)	0.4387
iAUC(0-180 min) (min/mmol/L)	17	34.42 (3.98, 64.86)	16	18.44 (-13.04, 49.92)	15.98 (26.78, 58.75)	0.4578
Cmax (mmol/L)	17	7.747 (7.43, 8.06)	16	7.44 (7.11, 7.77)	0.31 (-0.12, 0.73)	0.1560
Max_increase (mmol/L)	17	0.68 (0.36, 0.99)	16	0.37 (0.043, 0.70)	0.31 (-0.12, 0.73)	0.1560

AUC_{baseline_c (0-180 min)}: Baseline-corrected area under the curve from 0 to 180 min; AUC_{(0-180 min)}: Area under the curve from 0 to 180 min; iAUC_{(0-180 min)}: Incremental AUC_{(0-180 min)}, i.e., area above baseline levels of blood glucose concentration; C_max: Maximum blood glucose concentration; Max_increase: Maximum blood glucose concentration minus baseline value; LS mean: Adjusted least square mean obtained from analysis of covariance model

Table 5 Blood glucose endpoints: 30 g liquid lactulose vs water

	30 g liquid lactulose		Water		Treatment	P value
Variable	n	LS mean (95%CI)	n	LS mean (95%CI)	Difference (95%CI)
AUCbaseline_c (0-180 min) (min/mmol/L)	15	-41.01 (-88.72, 6.70)	16	-53.21 (-99.14, -7.28)	12.20 (-47.48, 71.88)	0.6843
AUC(0-180 min) (min/mmol/L)	15	1231.73 (1184.02, 1279.43)	16	1219.53 (1173.60, 1265.46)	12.20 (-47.48, 71.88)	0.6843
iAUC(0-180 min) (min/mmol/L)	15	42.05 (9.51, 74.60)	16	18.44 (-13.04, 49.92)	23.61 (-20.52, 67.75)	0.2890
Cmax (mmol/L)	15	8.07 (7.73, 8.41)	16	7.44 (7.11, 7.77)	0.63 (0.19, 1.07)	0.0059
Max_increase (mmol/L)	15	1.00 (0.66, 1.34)	16	0.37 (0.043, 0.70)	0.63 (0.19, 1.07)	0.0059

AUC_{baseline_c (0-180 min)}: Baseline-corrected area under the curve from 0 to 180 min; AUC_{(0-180 min)}: Area under the curve from 0 to 180 min; iAUC_{(0-180 min)}: Incremental AUC_{(0-180 min)}, i.e., area above baseline levels of blood glucose concentration; C_max: Maximum blood glucose concentration; Max_increase: Maximum blood glucose concentration minus baseline value; LS mean: Adjusted least square mean obtained from analysis of covariance model

Table 6 Blood glucose endpoints: 30 g glucose vs 30 g liquid and crystal lactulose

	Glucose 30 g		Liquid and crystal lactulose 30 g			Treatment	P value
Variable	n	LS mean (95%CI)	Formu-lation	n	LS mean (95%CI)	Difference (95%CI)
AUCbaseline_c (0-180 min) (min/mmol/L)	16	459.83 (413.74, 505.92)	Liquid	15	-41.01 (-88.72, 6.70)	500.84 (439.43, 562.26)	< 0.0001
			Crystals	16	-30.70 (-76.75, 15.35)	490.54 (431.89, 549.18)	< 0.0001
AUC(0-180 min) (min/mmol/L)	16	1732.57 (1686.48, 1778.66)	Liquid	15	1231.73 (1184.02, 1279.43)	500.84 (439.43, 562.26)	< 0.0001
			Crystals	16	1242.03 (1195.98, 1288.08)	490.54 (431.89, 549.18)	< 0.0001
iAUC(0-180 min) (min/mmol/L)	16	481.14 (449.56, 512.72)	Liquid	15	42.05 (9.51, 74.60)	439.08 (394.55, 483.62)	< 0.0001
			Crystals	16	27.65 (-3.91, 59.21)	453.49 (409.96, 497.02)	< 0.0001
Cmax (mmol/L)	16	13.22 (12.90, 13.55)	Liquid	15	8.07 (7.73, 8.41)	5.16 (4.71, 5.61)	< 0.0001
			Crystals	16	7.77 (7.44, 8.09)	5.46 (5.02, 5.89)	< 0.0001
Max_increase (mmol/L)	16	6.15 (5.83, 6.48)	Liquid	15	1.00 (0.66, 1.34)	5.16 (4.71, 5.61)	< 0.0001
			Crystals	16	0.70 (0.37, 1.02)	5.46 (5.02, 5.89)	< 0.0001

AUC_{baseline_c (0-180 min)}: Baseline-corrected area under the curve from 0 to 180 min; AUC_{(0-180 min)}: Area under the curve from 0 to 180 min; iAUC_{(0-180 min)}: Incremental AUC_{(0-180 min)}, i.e., area above baseline levels of blood glucose concentration; C_max: Maximum blood glucose concentration; Max_increase: Maximum blood glucose concentration minus baseline value; LS mean: Adjusted least square mean obtained from analysis of covariance model.