Clinical Trials Study
Copyright ©The Author(s) 2020.
World J Diabetes. Nov 15, 2020; 11(11): 514-526
Published online Nov 15, 2020. doi: 10.4239/wjd.v11.i11.514
Table 1 Baseline characteristics of patients in different change of waist-to-height ratio groups treated with acarbose
High ΔWHtRLow ΔWHtRP value
n178165
Demographic characteristics
Age, yr51.80 ± 8.8349.43 ± 9.360.016
Males/Females, n99/79110/550.046
Anthropometric measurements
Waist circumference, cm90.61 ± 8.3688.16 ± 8.270.007
Hip circumference, cm100.38 ± 7.6897.52 ± 7.05< 0.001
Body weight, kg69.98 ± 10.8470.41 ± 10.080.701
Body mass index, kg/m225.83 ± 2.7025.46 ± 2.490.193
Glucose metabolism variables
HbA1c, %7.44 ± 1.107.54 ± 1.400.437
FPG, mmol/L8.27 ± 1.348.18 ± 1.450.561
PPG, mmol/L12.54 ± 2.5912.70 ± 3.160.608
Blood pressure and lipid profile
Systolic blood pressure, mmHg124.08 ± 12.44122.85 ± 13.450.379
Diastolic blood pressure, mmHg79.06 ± 8.9579.48 ± 9.060.665
TC, mmol/L5.20 ± 1.065.30 ± 1.130.363
HDL-C, mmol/L1.24 ± 0.281.23 ± 0.300.683
LDL-C, mmol/L3.10 ± 0.863.11 ± 0.930.943
NHDL-C, mmol/L3.96 ± 1.014.08 ± 1.100.292
HDL-C/NHDL-C0.32 (0.25 to 0.40)0.30 (0.24 to 0.38)0.324
TG, mmol/L1.69 (1.15-2.35)1.88 (1.36-2.78)0.020
Hormones and insulin sensitivity
FINS, μIU/mL11.17 (7.48 to 16.01)10.30(6.38 to 15.85)0.012
I30/G302.44 (1.12 to 4.40)2.78 (0.87 to 4.62)0.012
HOMA-β48.31 (29.04 to 75.66)46.49 (27.61 to 72.66)0.195
AUCinsulin, μIU/L × min4.71 (3.28 to 6.54)4.33 (3.06 to 5.65)0.300
AUCGLP-1, nmol × min2.41 (1.96 to 4.06)3.24 (1.96 to 5.19)0.001
HOMA-IR4.00 (2.55 to 6.36)3.58 (2.25 to 6.02)0.003
WBISI68.43 (49.29 to 100.96)78.34 (51.86 to 119.52)0.610
WHtR: Change of waist-to-height ratio; TC: Total cholesterol; LDL-C: Low-density lipoprotein cholesterol; HDL-C: High-density lipoprotein cholesterol; TG: Triglycerides; HDL-C/non-HDL-C: HDL-C-to-non-HDL-C ratio; FPG: Fasting plasma glucose; PPG: Postprandial plasma glucose; FINS: Fasting plasma insulin; HOMA: Homeostasis model assessment-; IR: Insulin resistance; WBISI: Whole body insulin sensitivity index; AUC: Area under the curve; GLP-1: Glucagon-like peptide 1.
Table 2 Baseline characteristics of patients in different change of waist-to-height ratio groups treated with metformin
High ΔWHtRLow ΔWHtRP value
n157176
Demographic characteristics
Age51.34 ± 9.1049.48 ± 9.240.043
Males/Females, n84/73116/600.025
Anthropometric measurements
Waist circumference, cm90.64 ± 8.2388.95 ± 8.190.063
Hip circumference99.07 ± 7.4398.38 ± 7.390.396
Body weight, kg69.52 ± 10.6171.40 ± 10.750.111
Body mass index, kg/m225.90 ± 2.6025.59 ± 2.610.276
Glucose metabolism variables
HbA1c, %7.56 ± 1.237.60 ± 1.190.758
FPG, mmol/L8.44 ± 1.418.45 ± 1.430.924
PPG, mmol/L12.51 ± 3.0012.50 ± 2.970.975
Blood pressure and lipid profile
Systolic blood pressure, mmHg124.53 ± 12.25123.02 ± 13.850.293
Diastolic blood pressure, mmHg79.99 ± 6.3778.16 ± 9.120.035
TC, mmol/L5.30 ± 1.215.17 ± 1.040.267
HDL-C, mmol/L1.24 ± 0.301.24 ± 0.330.846
LDL-C, mmol/L3.11 ± 0.962.97 ± 0.890.160
NHDL-C, mmol/L4.06 ± 1.213.92 ± 1.020.254
HDL-C/NHDL-C0.32 (0.25 to 0.40)0.30 (0.24 to 0.38)< 0.001
TG, mmol/L2.00 (1.43-2.79)1.90 (1.27-3.86)0.293
Hormones and insulin sensitivity
FINS, μIU/mL11.35 (7.76 to 20.75)12.48 (7.24 to 24.11)0.361
HOMA-β48.27 (31.02 to 72.20)56.43 (28.51 to 76.43)0.417
I30/G302.39 (1.13 to 4.46)2.72 (0.97 to 4.49)0.609
AUCinsulin, μIU/L × min4.57 (3.20 to 6.18)4.58 (3.06 to 6.86)0.424
AUCGLP-1, nmol × min3.10 (1.75 to 5.03)2.61 (1.64 to 4.27)0.076
HOMA-IR4.34 (2.68 to 6.00)4.30 (2.74 to 6.93)0.165
WBISI69.45 (50.39 to 103.22)66.16 (43.84 to 98.52)0.031
WHtR: Change of waist-to-height ratio; TC: Total cholesterol; LDL-C: Low-density lipoprotein cholesterol; HDL-C: High-density lipoprotein cholesterol; TG: Triglycerides; HDL-C/non-HDL-C: HDL-C-to-non-HDL-C ratio; FPG: Fasting plasma glucose; PPG: Postprandial plasma glucose; FINS: Fasting plasma insulin; HOMA: Homeostasis model assessment-; IR: Insulin resistance; WBISI: Whole body insulin sensitivity index; AUC: Area under the curve; GLP-1: Glucagon-like peptide 1.
Table 3 Changes in key endpoints from baseline to week 24 of patients in different change of waist-to-height ratio groups treated with acarbose
High ΔWHtRLower ΔWHtRP value
Anthropometric measurements
Body weight, kg-3.63 (-4.08 to -3.18)-1.29 (-1.81 to -0.79)< 0.001
Body mass index, kg/m2-1.60 (-1.79 to -1.41)-0.56 (-0.72 to -0.39)< 0.001
Waist circumference, cm-5.57 (-6.05 to -5.09)0.87 (-0.42 to 1.32)< 0.001
Hip circumference-4.49 (-5.22 to -3.77)-0.13 (-0.72 to 0.45)< 0.001
Glucose metabolism variables
HbA1c, %-1.19 (-1.36 to -1.01)-1.11 (-1.32 to -0.90)0.511
FPG, mmol/L-1.47 (-1.67 to -1.27)-1.10 (-1.35 to 0.84)0.024
PPG, mmol/L-3.21 (-3.62 to -2.81)-2.82 (-3.32 to -2.32)0.546
Blood pressure and lipid profile
Systolic blood pressure, mmHg-2.11 (-3.97 to -0.25)-0.42 (-2.29 to 1.44)0.207
Diastolic blood pressure, mmHg-1.79 (-3.26 to -0.32)-2.35 (-3.63 to -1.07)0.574
TC, mmol/L-0.48 (-0.62 to 0.34)-0.27 (-0.43 to 0.12)0.103
HDL-C, mmol/L0.07 (-0.03 to 0.11)-0.01 (-0.05 to 0.03)0.012
LDL-C, mmol/L-0.22 (-0.34 to -0.09)-0.07 (-0.20 to 0.07)0.158
NHDL-C, mmol/L-0.55 (-0.69 to -0.41)-0.27 (-0.42 to -0.11)0.021
HDL-C/NHDL-C0.08 (0.06 to 0.10)0.03 (0.01 to 0.05)< 0.001
TG, mmol/L-0.62 (-0.87 to -0.37)-0.90 (-0.42 to -0.07)0.562
Hormones and insulin sensitivity
HOMA-β-0.58 (-10.07 to 8.92)10.09 (-13.30 to 33.49)0.195
I30/G30-0.02 (-2.93 to 2.90)1.43 (-0.09 to 2.95)0.012
FINS, μIU/mL-4.73 (-6.27 to -3.19)-2.88 (-4.80 to -0.95)0.012
AUCinsulin, μIU/L × min-1.47 (-1.86 to -1.07)-0.794 (-1.16 to -0.43)0.092
AUCGLP-1, nmol × min1.41 (1.04 to 1.78)0.65 (1.87 to 1.11)0.002
HOMAIR-2.30 (-2.87 to -1.74)-1.53 (-2.19 to -0.87)0.003
WBISI69.38 (56.59 to 82.17)47.78 (34.63 to 60.93)0.610
WHtR: Change of waist-to-height ratio; TC: Total cholesterol; LDL-C: Low-density lipoprotein cholesterol; HDL-C: High-density lipoprotein cholesterol; TG: Triglycerides; HDL-C/non-HDL-C: HDL-C-to-non-HDL-C ratio; FPG: Fasting plasma glucose; PPG: Postprandial plasma glucose; FINS: Fasting plasma insulin; HOMA: Homeostasis model assessment; IR: Insulin resistance; WBISI: Whole body insulin sensitivity index; AUC: Area under the curve; GLP-1: Glucagon-like peptide 1.
Table 4 Changes in key endpoints from baseline to week 24 of patients in different change of waist-to-height ratio groups treated with metformin
High ΔWHtRLow ΔWHtRP value
Anthropometric measurements
Body weight, kg-2.85 (-3.28 to -2.44)-0.95 (-1.37 to -0.52)< 0.001
Body mass index, kg/m2-1.30 (-1.48 to -1.12)-0.40 (-0.59 to 0.22)< 0.001
Waist circumference, cm-5.51(-6.11 to -4.90)-1.01 (-0.60 to 1.42)< 0.001
Hip circumference-2.96 (-3.75 to -2.17)-0.15 (-0.82 to 0.52)< 0.001
Glucose metabolism variables
HbA1c, %-1.34 (-1.52 to 1.167-1.14 (-1.31 to 0.96)0.106
FPG, mmol/L-2.03 (-2.24 to -1.81)-1.60 (-1.81 to -1.39)0.005
PPG, mmol/L-2.91 (-3.37 to -2.44)-2.30 (-2.79 to -1.81)0.659
Blood pressure and lipid profile
Systolic blood pressure, mmHg-2.42 (-4.36 to -0.49)-0.60 (-2.47 to 1.48)0.172
Diastolic blood pressure, mmHg-2.69 (-4.10 to -1.29)-0.28 (-1.69 to 1.15)0.018
TC, mmol/L-0.53 (-0.68 to -0.39)-0.19 (-0.35 to -0.03)0.004
HDL-C, mmol/L0.06 (0.03 to 0.10)-0.01 (-0.05 to -0.03)0.458
LDL-C, mmol/L-0.33 (-0.46 to -0.20)-0.12 (-0.25 to -0.00)0.047
NHDL-C, mmol/L-0.53 (-0.68 to -0.39)-0.18 (-0.33 to -0.02)0.001
HDL-C/NHDL-C0.05 (0.05 to 0.07)0.00 (-0.03 to 0.03)0.003
TG, mmol/L-0.38 (-0.00 to 0.76)-0.18 (-0.42 to 0.06)0.003
Hormones and insulin sensitivity
FINS, μIU/mL-3.76 (-4.95 to -2.58)-3.47 (-5.03 to -1.93)0.361
HOMA-β12.13 (5.20 to 19.06)12.50 (2.72 to 22.28)0.417
I30/G3060.38 (47.81 to 72.94)41.50 (30.72 to 52.29)0.031
AUCinsulin, μIU/L × min-0.35 (-0.72 to 0.014)-0.56 (-0.91 to -0.21)0.743
AUCGLP-1, nmol × min0.75 (0.25 to 1.26)1.17 (0.77 to 1.56)0.340
HOMAIR-2.20 (-2.67 to -1.73)-2.06 (-2.63 to -1.49)0.165
WBISI0.44 (-2.55 to 3.43)0.14 (-2.34 to 2.62)0.609
WHtR: Change of waist-to-height ratio; TC: Total cholesterol; LDL-C: Low-density lipoprotein cholesterol; HDL-C: High-density lipoprotein cholesterol; TG: Triglycerides; HDL-C/non-HDL-C: HDL-C-to-non-HDL-C ratio; FPG: Fasting plasma glucose; PPG: Postprandial plasma glucose; FINS: Fasting plasma insulin; HOMA: Homeostasis model assessment-; IR: Insulin resistance; WBISI: Whole body insulin sensitivity index; AUC: Area under the curve; GLP-1: Glucagon-like peptide 1.
Table 5 Baseline factors associated with a high change of waist-to-height ratio
Univariate
Multivariate
OR (95%CI)P valueOR (95%CI)P value
Acarbose
Age1.032 (1.008 to 1.056)0.0091.023 (0.998 to 1.049)0.070
Sex1.554 (1.006 to 2.401)0.0471.654 (1.011 to 2.546)0.045
AUCGLP-1, nmol × min0.134 (0.043 to 0.420)0.0010.796 (0.705 to 0.898)< 0.001
Metformin
Age1.025 (1.001 to 1.049)0.0431.013 (0.988 to 1.039)0.313
Sex1.684 (1.086 to 2.612)0.0201.718 (1.091 to 2.704)0.020
AUCGLP-1, nmol × min2.808 (0.979 to 8.059)0.0551.133 (1.016 to 1.263)0.025
AUCGLP-1: Area under the curve of glucagon-like peptide 1.
Table 6 Association between changes in glucagon-like peptide 1 and a high change of waist-to-height ratio
Univariate
Multivariate
OR (95%CI)
P value
OR (95%CI)
P value
Acarbose
AUCinsulin, μIU/L × min0.897 (0.814 to 0.987)0.0270.922 (0.830 to 1.024)0.127
AUCGLP-1, nmol × min1.136 (1.044 to 1.237) 0.0031.121 (1.022 to 1.230)0.016
HDL-C/NHDL-C17.934 (3.165 to 101.613)0.00120.735 (3.416 to 125.871)0.001
Metformin
FPG, mmol/L0.803 (0.687 to 0.938)0.0060.843 (0.717 to 0.992)0.039
TC0.707 (0.560 to 0.893)0.0040.743 (0.587 to 0.940)0.013
AUC: Area under the curve; GLP-1: Glucagon-like peptide 1; HDL-C/non-HDL-C: HDL-C-to-non-HDL-C ratio; FPG: Fasting plasma glucose; TC: Total cholesterol.