Table 2.
Descriptive and statistical results for changes in weight, respiratory, sleepiness, sleep architecture, metabolic and quality of life parameters after the 2-year weight reduction program (per protocol analysis [PP] and intention to treat analysis [ITT])
| Numbers at 2 years | Baseline Mean (SD) | 2 years Mean (SD) | PP p-value WSR | ITT p-value WSR | |
|---|---|---|---|---|---|
| Weight (kg) | 23 | 122(19) | 110(15) | < 0.001 | 0.003 |
| BMI (kg/m2) | 23 | 40(5) | 35(3) | < 0.001 | 0.003 |
| Body fat % | 18 | 43(6) | 36(8) | < 0.001 | 0.040 |
| Body fat mass (kg) | 18 | 52(11) | 41(11) | < 0.001 | 0.007 |
| Waist circumference (cm) | 18 | 127(14) | 118(9) | 0.002 | n.s. |
| Waist Hip ratio | 18 | 1.01(0.1) | 1.02(0.1) | n.s. | n.s. |
| AHI | 22 | 43(24) | 28(19) | 0.054 | n.s. |
| ODI4 | 22 | 42(23) | 23(15) | < 0.001 | 0.010 |
| ESS | 22 | 9(4) | 5(3) | 0.003 | 0.026 |
| Arousal Index | 22 | 24(15) | 11(11) | < 0.001 | 0.019 |
| Deep sleep % | 22 | 16(11) | 19(10) | n.s. | n.s. |
| REM sleep % | 22 | 14(7) | 16(8) | n.s. | n.s. |
| Total sleep time | 22 | 357(67) | 338(83) | 0.097 | n.s. |
| Total wake time | 22 | 60(42) | 55(29) | n.s. | n.s. |
| Sleep efficiency | 22 | 78(10) | 79(12) | n.s. | n.s. |
| Stage shift index | 22 | 17(11) | 11(10) | < 0.001 | 0.003 |
| Awakening Index | 22 | 4(7) | 5(9) | n.s. | n.s. |
| Sleep latency | 22 | 31(19) | 24(17) | 0.076 | n.s. |
| fP-Glucose (mmol/L) | 21 | 7.2(2.7) | 7.0(3.3) | 0.082 | n.s. |
| B-HbA1C (%) | 21 | 5.7(1.3) | 5.6(1.7) | 0.059 | n.s. |
| fS-Insulin (pmol/L) | 21 | 147(78) | 90(52) | 0.014 | 0.078 |
| P-Cholesterol (mmol/L) | 21 | 5.3(1.1) | 4.9(1.2) | n.s. | n.s. |
| P-Triglycerides (mmol/L) | 21 | 1.8(0.8) | 1.6(0.7) | 0.042 | n.s. |
| P-HDL (mmol/L) | 21 | 1.2(0.3) | 1.4(0.5) | < 0.001 | 0.037 |
| P-LDL (mmol/L) | 21 | 3.4(1.0) | 2.7(1.1) | 0.008 | n.s. |
| P-ASAT (ukat/L) | 21 | 0.5(0.3) | 0.5(0.3) | 0.085 | n.s. |
| P-ALAT (ukat/L) | 21 | 0.7(0.4) | 0.6(0.5) | n.s. | n.s. |
| P-ALP (ukat/L) | 15 | 3.1(0.9) | 2.9(1.0) | n.s. | n.s. |
| P-GGT (ukat/L) | 21 | 0.9(0.8) | 0.7(0.7) | < 0.001 | n.s. |
| P-Urat (umol/L) | 21 | 400(69) | 418(86) | n.s. | n.s. |
| Syst BP (mm Hg) | 13 | 144(19) | 129(10) | n.s. | n.s. |
| Diast BP (mm Hg) | 13 | 89(14) | 81(6) | n.s. | n.s. |
| SF-36: PF | 18 | 62(27) | 77(26) | 0.031 | n.s. |
| SF-36: RP | 18 | 67(40) | 74(36) | n.s. | n.s. |
| SF-36: BPain | 18 | 62(29) | 67(29) | n.s. | n.s. |
| SF-36: GH | 18 | 57(24) | 61(27) | n.s. | n.s. |
| SF-36: VT | 18 | 49(24) | 62(27) | 0.046 | n.s. |
| SF-36: SF | 18 | 82(20) | 82(25) | n.s. | n.s. |
| SF-36: RE | 18 | 75(39) | 78(36) | n.s. | n.s. |
| SF-36: MH | 18 | 74(19) | 80(16) | n.s. | n.s. |
p-values < 0.1 are specified, and ≥ 0.1 abbreviated as non-significant (n.s.). BMI, body mass index; Body fat %, percentage body fat; AHI, apnea hypopnea index; ODI4, oxygen desaturation index; ESS, Epworth Sleepiness Scale; Deep sleep %, percentage slow wave sleep; REM sleep %, percentage REM sleep; fP-Glucos, fasting plasma glucose level; HbA1C, glycosylated hemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; ASAT, aspartate aminotransferase; ALAT, alanine aminotransferase; ALP, alkaline phosphatase; GGT, gamma-glutamyl transpeptidase; Syst BP, systolic blood pressure; Diast BP, diastolic blood pressure; SF-36, Short Form 36. PF, Physical Functioning; RP, Role Physical; BPain, Bodily Pain; GH, General Health; VT, Vitality; SF, Social Functioning; RE, Role Emotional; MH, Mental Health; WSR, Wilcoxon signed rank test; n.s., non significant