Table 1. Table outlines the change in weight, BMI, blood pressure, insulin glucose metabolism, lipids, TBLH fat mass %, TBLH bone mineral density, TBLH bone area and bone mineral content, Lumbar bone mineral density, Bone area and bone mineral content between baseline, balloon removal at 6 months and 2 years (18 months after balloon removal).
| Before Balloon insertion N=12 Mean (±s.d.) | After Balloon removal N=12 Mean (±s.d.) | At 2 years N=10 Mean (±s.d.) | Mean difference between baseline and balloon removal at 6 months (95 CI) (P-value) | Mean difference between baseline and 24 months (95 CI) (P-value) | |
|---|---|---|---|---|---|
| Body weight (kg) | 138.5 (23.9) | 131.4 (23.1) | 148.4 (25.2) | −7.1 (−27, 12.8) (P=0.005) | +9.9 (−11.8, 31.8) (P=0.4) |
| BMI (kg m−2) | 46.4 (5.6) | 43.9 (5.5) | 49.3 (8.1) | −2.5 (−7.2, 2.2) (P=0.004) | +2.9 (−3,8.8) (P=0.5) |
| BMI SDS | 4 (0.3) | 3.8 (0.3) | 4.2 (0.5) | −0.2 (−0.37, −0.03) (P=0.002) | +0.2 (−0.1, 0.5) (P=0.5) |
| Waist circumference (cm) | 128.3 (19.1) | 115.9 (15.6) | 138.7 (21.2) | −12.4 (−27.2, 2.4) (P=0.016) | +10.4 (−6.7, 27.5) (P=0.3) |
| Systolic BP (mm of Hg) | 127.8 (11.9) | 122 (16) | 132.2 (18.3) | −5.8 (−17.7, 6.1) (P=0.3) | +4.4 (−9.1, 17.1) (P=0.5) |
| Diastolic BP (mm of Hg) | 74.8 (5.4) | 72.8 (9.5) | 72 (7.5) | −2.0 (−8.5, 4.5) (P=0.6) | −2.8 (−8.3, 2.3) (P=0.2) |
| Fasting glucose (mmol) | 4.3 (0.3) | 4.3 (0.3) | 4.7 (0.4) | −0.03 (−0.25, 0.25) (P=0.5) | +0.4 (0.1, 0.7) (P=0.1) |
| Fasting Hyperinsulinemia (pmol/l) | 209.6 (141.6) | 189 (116.4) | 213.6 (106.4) | −20.6 (−130.3, 89) (P=0.3) | +4 (109.4, 117) (P=0.8) |
| HOMA IR | 6.6 (4.7) | 5.2 (3.2) | 7.4 (3.8) | −1.4 (−4.8, 2) (P=0.5) | +0.8 (−3.1, 4.7) (P=0.6) |
| Insulin (AUC; pmol l−1) | 3387 (2417) | 2173 (1845) | 2780 (2588) | −1214 (3034, 606) (P=0.05) | −607 (−2835, 1621) (P=0.4) |
| ALT | 47.3 (25.6) | 43 (23.8) | 48.8 (28.7) | −4.3 (−25.2, 16.6) (P=0.4) | +1.5 (−22.7, 25.7) (P=0.7) |
| Gamma GT | 32.9 (13.1) | 25.8 (9.5) | 29.4 (12.5) | −7.1 (−16.8, 2.6) (P=0.03) | −3.5 (−15, 8) (P=0.3) |
| Cholesterol | 4.4 (0.7) | 4.1 (0.6) | 4.3 (0.8) | −0.3 (−0.85, 0.25) (P=0.2) | −0.1 (−0.8, 0.6) (P=0.4) |
| Triglycerides | 1.5 (0.7) | 1.9 (0.8) | 1.3 (0.6) | +0.4 (−0.24, 1.04) (P=0.1) | −0.2 (−0.8, 0.4) (P=0.4) |
| HBA1c (mmol mol−1) | 36.2 (2.5) | 35.1 (1.8) | 34.1 (2) | −1.1 (−2.9, 0.7) (P=0.08) | −2.1 (−4.1, −0.1) (P=0.005) |
| TBLH fat mass % | 54.9 (3.5) | 52.8 (5.2) | 54.9 (7.5) | −2.1 (−5.9, 1.7) (P<0.05) | 0.0 (−5.0, 5.0) (P=0.5) |
| TBLH BMD (g cm−2) | 1.15 (0.07) | 1.15 (0.06) | 1.19 (0.08) | 0.002 (−0.03, 0.03) (P=0.9) | 0.04 (0.01, 0.06) (P=0.01) |
| TBLH BMD Z score | 1.7 (1) | 1.64 (0.9) | 1.97 (1.1) | −0.06 (−0.9, 0.7) (P=0.3) | 0.27 (−0.65, 1.19) (P=0.3) |
| TBLH BA (cm2) | 2010.2 (240.7) | 2056.5 (205.3) | 1958.3 (252.8) | 46.4 (−15.8, 108) (P=0.13) | −22.5 (−97.5, 52.5) (P=0.52) |
| TBLH BMC (gm) | 2307.9 (287.6) | 2368.6 (254.1) | 2343.9 (334.5) | 60.7 (5.5, 115.9) (P=0.03) | 43.9 (−20.6, 108.4) (P=0.16) |
| L1-L4 BMD(g cm−2) | 1.23 (0.2) | 1.26 (0.2) | 1.28 (0.2) | 0.03 (0.01, 0.04) (P=0.01) | 0.04 (−0.02, 0.10) (P=0.14) |
| L1-L4 BMD z score | 0.9 (1.2) | 0.87 (1.2) | 0.76 (1.3) | −0.03 (−1.09, 1.03) (P=0.6) | −0.14 (−1.26, 0.98) (P=0.6) |
| L1-L4 BA (cm2) | 57.4 (7.6) | 58.1 (7.5) | 58.8 (7.1) | 0.8 (0.4, 1.2) (P=0.002) | 2.0 (0.9, 3.0) (P=0.003) |
| L1-L4 BMC (gm) | 70.5 (13.0) | 73.0 (13.3) | 75.6 (14.0) | 2.5 (1.4, 3.6) (P=0.001) | 5.3 (1.0, 9.5) (P=0.02) |
Abbreviations:
ALT, alanine transaminase; BA, bone area; BMC, bone
mineral content; BMD, bone mineral density; TBLH, total body less head.
Reference population used to calculate the BMI Z score was based on the UK90 growth charts.