Table 4.
Differences in anthropometric, biochemical, and clinical measurements at baseline and after 12 weeks for the full analysis set (n=38).
|
|
Baseline | Week 12 | Change from baseline to week 12 | P value | |||||
| Anthropometry | |||||||||
|
|
Weight (kg), mean (SD) | 110.0 (18.5) | 106.5 (18.4) | 3.5 (3.7) | <.001a | ||||
|
|
Relative percentage weight changeb, mean (SD) | N/Ac | N/A | 3.2 (3.4) | N/A | ||||
|
|
BMI (kg/m2), mean (SD) | 37.6 (5.8) | 36.4 (5.8) | 1.2 (1.3) | <.001a | ||||
|
|
Waist circumference (cm), mean (SD) | 123.8 (12.2) | 119.9 (12.2) | 4.0 (5.1) | <.001a | ||||
|
|
Hip circumference (cm), mean (SD) | 125.1 (14.0) | 123.2 (13.3) | 1.8 (0.0 to 4.9) | .01d | ||||
|
|
Waist to hip ratio, median (IQR) | 1.00 (0.95 to 1.03) | 0.99 (0.92 to 1.03) | 0.00 (–0.01 to 0.03) | .09d | ||||
| Liver assessment | |||||||||
|
|
Liver fat MRI-PDFFe (%), mean (SD) | 12.3 (7.1) | 10.1 (6.5) | 2.2 (2.9) | <.001a | ||||
|
|
Liver fat MRI-PDFF relative changeb (%), mean (SD) | N/A | N/A | 19.4 (23.9) | N/A | ||||
|
|
Liver stiffness measure (kPa), median (IQR) | 6.4 (5.2 to 9.6) | 6.6 (5.3 to 8.4) | 0.2 (–0.3 to 1.6) | .11d | ||||
|
|
CAPf score (dB/m), mean (SD) | 343.6 (34.8) | 310.3 (47.2) | 33.3 (39.7) | <.001a | ||||
| Body compositiong | |||||||||
|
|
Total body region fat (%), median (IQR) | 46.6 (39.4 to 52.4) | 44.3 (37.8 to 52.2) | 0.9 (1.4)b | <.001a | ||||
|
|
Fat mass (kg), mean (SD) | 50.3 (13.8) | 48.1 (14.5) | 2.2 (2.7) | <.001a | ||||
|
|
Lean mass (kg), mean (SD) | 56.3 (10.1) | 55.6 (9.7) | 0.7 (1.7) | .008a | ||||
| Blood pressure (mmHg), mean (SD) | |||||||||
|
|
Systolic | 141.4 (17.1) | 135.4 (17.3) | 6.0 (13.5) | 0.009a | ||||
|
|
Diastolic | 83.6 (7.4) | 82.5 (7.4) | 1.2 (7.7) | .36a | ||||
| Biochemical measures | |||||||||
|
|
HbA1ch (mmol/mol), median (IQR) | 60.0 (56.0 to 66.8) | 60.0 (54.3 to 64.0) | 0.5 (–0.7 to 3.8) | .03d | ||||
|
|
S-glucosei (mmol/L), median (IQR) | 6.2 (5.3 to 7.4) | 6.3 (5.4 to 6.9) | 0.0 (–0.3 to 0.4) | .64d | ||||
|
|
S-insulinj (µU/ml), median (IQR) | 21.1 (16.4 to 27.9) | 19.0 (13.0 to 25.0) | 3.2 (0.0 to 5.4) | .003d | ||||
|
|
HOMA-IRk (mmol/L), median (IQR) | 5.8 (4.3 to 8.4) | 4.8 (3.6 to 7.2) | 0.4 (–0.2 to 2.1) | .02d | ||||
|
|
Total cholesterol (mmol/L), mean (SD) | 4.9 (1.3) | 4.8 (1.2) | 0.0 (–0.2 to 0.2) | >.99d | ||||
|
|
LDL-Cl (mmol/L), mean (SD) | 2.9 (1.1) | 2.9 (1.1) | –0.1 (–0.3 to 0.1) | .18d | ||||
|
|
HDL-Cm (mmol/L), mean (SD) | 1.11 (0.23) | 1.12 (0.19) | –0.01 (0.12) | .56a | ||||
|
|
Triglycerides (mmol/L), median (IQR) | 1.88 (1.35 to 2.45) | 1.68 (1.21 to 1.90) | 0.14 (0.00 to 0.47) | .003d | ||||
|
|
hs-CRPn (mg/L), median (IQR) | 3.0 (1.2 to 5.2) | 2.5 (1.1 to 3.9) | 0.1 (–0.1 to 0.7) | .14d | ||||
|
|
ALATo (IU/L), median (IQR) | 21.4 (18.2 to 30.2) | 23.2 (18.4 to 32.0) | 0.0 (–6.8 to 2.8) | .37d | ||||
|
|
ASATp (IU/L), median (IQR) | 20.8 (17.9 to 24.8) | 22.3 (18.0 to 25.5) | 0.4 (–2.5 to 2.5) | .53d | ||||
|
|
FIB-4q Index, median (IQR) | 1.08 (0.78 to 1.34) | 1.08 (0.75 to 1.21) | 0.01 (–0.06 to 0.07) | .58d | ||||
aAnalyzed with a paired t test.
bPercentage change calculated as the average over individual relative changes.
cN/A: not applicable.
dAnalyzed with a Wilcoxon signed-rank test.
eMRI-PDFF: magnetic resonance imaging proton density fat fraction.
fCAP: controlled attenuation parameter.
gMeasured by dual-energy ray absorptiometry.
hHbA1c: glycated hemoglobin A1c.
is-glucose: Serum glucose.
js-insulin: Serum insulin.
kHOMA-IR: homeostatic model assessment of insulin resistance.
lLDL-C: low-density lipoprotein cholesterol.
mHDL-C: high-density lipoprotein cholesterol.
nhs-CRP high-sensitivity C-reactive protein.
oALAT: alanine aminotransferase.
pASAT: aspartate aminotransferase.
qFIB-4: index for liver fibrosis.