Table 3: Final result at the end of the 12-month

treatment with the Spatz-3® balloon.

Variable

Baseline

SD

Removal

SD

Difference

p

Weight (kg)

97.5

7.9

83.3

11.9

14.2

< 0.001

BMI (kg/m2)

36.5

2.7

31.2

4.4

5.3

< 0.001

Weight

excess (kg)

40.1

7.1

25.9

11.7

14.2

< 0.001

Glucose

(mg/dl)

98.0

21.4

99.7

41.7

-1.7

0.300

Triglycerides

(mg/dl)

148.6

54.3

139.0

84.9

9.6

0.200

HDL (mg/dl)

65.8

46.8

52.1

12.5

13.7

0.700

AST (U/l)

27.7

8.2

22.8

6.7

4.9

0.009

ALT (U/l)

30.8

10.2

23.6

9.9

7.2

0.002

HbA1c (%)

6.4

1.3

6.3

1.8

0.1

0.200

SD = standard deviation.

BMI = body mass index.

HDL = high-density lipoproteins.

AST = aspartate aminotransferase.

ALT = alanine aminotransferase.

HbA1c = glycated hemoglobin.

Source: electronic file OrmaMed.