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Table 4 Mean values in clinical outcomes assessed at baseline and follow-up assessments for intervention and control groups and a comparison of the differences in the change between groups

From: Electrically assisted cycling for individuals with type 2 diabetes mellitus: a pilot randomized controlled trial

Outcome

Intervention

Control

Difference in change (CI)

  

Pre

Post

Change

 

Pre

Post

Change

 

N

Mean (CI)

(aMedian; IQR)

Mean (CI)

(aMedian; IQR)

Mean (CI)

(aMedian; IQR)

N

Mean (CI)

(aMedian; IQR)

Mean (CI)

(aMedian; IQR)

Mean (CI)

(aMedian; IQR)

Anthropometrics

  Weight, kg

13

95.96 (84.16, 107.76)

94.11 (82.98, 105.23)

 − 1.85 (− 4.10, 0.40)

17b

97.99 (85.39, 110.59)

97.61 (85.12, 110.11)

 − 0.38 (− 1.82, 1.07)

1.47 (− 0.97, 3.91)

  BMI, kg/m2

13

32.98 (28.64, 37.31)

32.37 (28.15, 36.60)

 − 0.60 (− 1.32, 0.11)

17b

32.32 (29.21, 35.44)

32.18 (29.13, 35.24)

 − 0.14 (− 0.61, 0.33)

0.46 (− 0.32, 1.24)

  Waist circumference, cm

13

113.27 (103.75, 122.78)

107.88 98.93, 116.84)

 − 5.38 (− 9.09, − 1.68)

17b

112.09 (103.43, 120.75)

111.46 (101.93, 120.99)

 − 0.63 (− 3.36, 2.10)

4.76 (0.47, 9.04)

Fasting bloods

  HbA1c, mmol/mol

12c

55.00 (47.26, 62.74)

53.67 (46.81, 60.52)

 − 1.33 (− 3.35, 0.68)

11c

52.64 (44.26, 61.01)

52.55 (43.45, 61.45)

 − 0.09 (− 1.42, 1.23)

1.24 (− 1.07, 3.56)

  Fasting glucose, mmol/L

13

7.84 (6.51, 9.16)

7.62 (6.44, 8.79)

 − 0.22 (− 0.70, 0.26)

14d

7.14 (5.99, 8.29)

7.59 (5.57, 9.62)

0.45 (− 0.94, 1.84)

0.67 (− 0.77, 2.11)

  Fasting insulin, mIU/L

13

20.31 (11.26, 29.35)

18.19 (12.30, 24.09)

 − 2.12 (− 7.91, 3.68)

13d

16.97 (11.92, 22.02)

18.69 (12.17, 24.22)

1.72 (− 2.48, 5.93)

3.84 (− 2.94, 10.62)

  HOMA-B, %

13

94.68 (52.01, 137.36)

93.95 (56.55, 131.36)

 − 0.73 (− 16.91, 15.45)

13d

92.75 (63.50, 122.01)

105.18 (68.12, 142.24)

12.42 (− 4.41, 29.26)

13.15 (− 8.97, 35.27)

  HOMA-IR, unitless

13

2.82 (1.66, 3.98)

2.53 (1.78, 3.29)

 − 0.28 (− 1.04, 0.47)

13d

2.39 (1.68, 3.11)

2.69 (1.80, 3.59)

0.30 (− 0.30, 0.90)

0.58 (− 0.33, 1.50)

  C-reactive protein, mg/L

13

1.0 (0.9, 4)

2.0 (0.9, 4)

0.1 (0, 1.1)

14d

2.5 (2, 4)

3.0 (2, 4)

0.0 (0, 1)

 

  Total cholesterol, mmol/L

13

3.91 (3.30, 4.51)

3.95 (3.38, 4.51)

0.04 (− 0.27, 0.35)

15

4.12 (3.70, 4.54)

4.46 (3.80, 5.12)

0.34 (− 0.14, 0.82)

0.30 (− 0.27. 0.87)

  Triglycerides, mmol/L

13

1.82 (1.23, 2.42)

1.81 (1.30, 2.32)

 − 0.02 (− 0.26, 0.23)

15

1.57 (1.16, 1.99)

1.51 (1.15, 1.87)

 − 0.06 (− 0.26, 0.14)

 − 0.04 (− 0.35, 0.26)

  HDL cholesterol, mmol/L

13

1.32 (1.02, 1.61)

1.23 (1.01, 1.45)

 − 0.08 (− 0.19, 0.02)

15

1.13 (0.98, 1.29)

1.19 (1.02, 1.35)

0.05 (− 0.02, 0.13)

0.14 (0.02, 0.26)

  LDL cholesterol, mmol/L

12

1.75 (1.35, 2.15)

1.93 (1.49, 2.36)

0.18 (− 0.88, 0.44)

15

2.26 (1.88, 2.64)

2.58 (1.97, 3.19)

0.32 (− 0.10, 0.74)

0.15 (− 0.36, 0.65)

  Non-HDL cholesterol, mmol/L

13

2.59 (2.08, 3.10)

2.72 (2.24, 3.19)

0.12 (− 0.19, 0.44)

15

2.99 (2.63, 3.34)

3.27 (2.66, 3.88)

0.29 (− 0.18, 0.76)

0.16 (− 0.40, 0.72)

Dynamic measures of glucose homeostasis

  iAUC glucose, mmol/L/120 min

9

693.33 (536.90, 849.77)

675.5 (552.48, 798.52)

 − 17.83 (− 195.75, 298.5)

10d

502.35 (340.81, 663.89)

504.98 (418.29, 591.66)

2.63 (− 89.34, 94.59)

20.46 (− 114.21, 155.13)

  iAUC insulin, mIU/L/120 min

9

6515.08 (2823.02, 10,207.14)

6844.58 (3184.05, 10,505.12)

329.5 (− 2685, 3122.25)

10d

4744.95 (1674.78, 7815.12)

5201.78 (2134.91, 8268.64)

456.83 (− 412.58, 1326.23)

280.37 (− 1003.66, 1564.40)

  Matsuda index, unitless

9

2.29 (0.74, 4.06)

2.43 (1.05, 4.81)

0.13 (− 1.69, 1.15)

10d

3.00 (0.91, 6.35)

2.37 (0.64, 4.42)

 − 0.64 (− 3.38, 1.29)

 − 0.77 (− 1.84, 0.30)

  Original insulinogenic index (0–30 min), pmol/mmole,f

10

46.33 (5.39, 77.5)

48.11 (6.23, 97.69)

1.77 (− 28.67, 30.29)

11d

59.68 (6, 231)

61.71 (9.6, 148.8)

2.02 (− 178.81, 137.29)

0.24 (− 51.50, 51.99)

  Total insulinogenic index

(0–120 min), pmol/mmolf

9

63.60 (4.17, 135.09)

68.57 (5.60, 200.03)

4.97 (− 25.21, 64.94)

10d

63.73 (18.59, 146.83)

61.83 (23.44, 168.59)

 − 1.89 (− 43.19, 21.76)

 − 6.86 (− 29.96, 16.23)

  Insulin secretion-sensitivity index 2, unitless

9

58.57 (13.21, 154.59)

66.74 (18.48, 142.07)

8.17 (− 44.08, 68.90)

10d

80.39 (20.82, 199.58)

69.60 (12.15, 121.72)

 − 10.79 (− 77.86, 44.34)

 − 18.97 (− 50.41, 12.48)

Health-related quality of life

  Physical component

13

64.62 (51.82, 77.41)

68.89 (56.41, 81.38)

4.28 (− 6.79, 15.35)

17

71.54 (62.34, 80.74)

69.67 (58.15, 81.18)

 − 1.88 (− 13.05, 9.30)

 − 6.15 (− 21.16, 8.85)

  Mental component

13

67.42 (56.07, 78.77)

71.02 (60.62, 81.42)

3.60 (− 6.20, 13.40)

17

76.27 (67.95, 84.60)

75.46 (66.73, 84.20)

 − 0.81 (− 11.54, 9.92)

 − 4.41 (− 18.28, 9.46)

  1. BMI body mass index, CI confidence interval, HbA1c glycated haemoglobin, HDL high-density lipoprotein: HOMA-B homeostasis model assessment of β-cell function, HOMA-IR homeostasis model assessment of insulin resistance, IQR interquartile range, LDL low-density lipoprotein, iAUC incremental area under the curve
  2. aWhen data are non-normally distributed, based on visual inspection, median and IQR are reported. bData from one participant dropped due to having a gastric band during the study. cIndividuals removed due to change in medication status. dData from one participant removed due to taking antibiotics at baseline which impacts measures of glucose and insulin, therefore skewing the data. eOriginal insulinogenic index required blood samples at 0 and 30 min; therefore, two participants not included in other dynamic glucose measures were included in this calculation. fmIU/L was converted to pmol/L. The conversion factor of 1mIU/L = 6 pmol/L was used
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Pilot and Feasibility Studies

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