. | DIAMOS group (n = 93) . | CG (n = 88) . | Adjusted between-group change from baseline to end point . | Adjusted P values between groups . |
---|---|---|---|---|
Primary outcome—depressive symptoms1,2 | ||||
CES-D score | 3.9 ± 1.7 (0.6–7.3) | 0.021 | ||
Baseline | 24.4 ± 7.5 | 22.1 ± 8.6 | ||
End point | 17.0 ± 10.0 | 19.4 ± 11.8 | ||
Baseline to end point change | −7.4 ± 11.4 (P < 0.001) | −2.7 ± 11.7 (P = 0.036) | ||
Secondary outcomes1,2 | ||||
Psychological variables | ||||
PHQ-9 score | 1.7 ± 0.8 (0.2–3.2) | 0.023 | ||
Baseline | 10.9 ± 4.3 | 9.6 ± 3.8 | ||
End point | 7.5 ± 4.8 | 8.4 ± 5.0 | ||
Baseline to end point change | −3.3 ± 5.1 (P < 0.001) | −1.2 ± 5.7 (P = 0.050) | ||
WHO-5 score | −1.5 ± 0.9 (−3.2 to 0.3) | 0.097 | ||
Baseline | 8.2 ± 4.0 | 9.6 ± 4.9 | ||
End point | 12.7 ± 5.5 | 12.1 ± 6.1 | ||
Baseline to end point change | 4.5 ± 6.1 (P < 0.001) | 2.5 ± 6.3 (P < 0.001) | ||
DDS score | 0.3 ± 0.1 (0.1–0.5) | 0.012 | ||
Baseline | 2.8 ± 0.9 | 2.6 ± 0.8 | ||
End point | 2.1 ± 0.8 | 2.3 ± 0.8 | ||
Baseline to end point change | −0.7 ± 1.0 (P < 0.001) | −0.4 ± 0.7 (P < 0.001) | ||
PAID score | 8.2 ± 2.6 (3.1–13.3) | 0.002 | ||
Baseline | 41.1 ± 19.1 | 37.9 ± 17.5 | ||
End point | 28.1 ± 18.4 | 33.7 ± 19.7 | ||
Baseline to end point change | −13.0 ± 18.9 (P < 0.001) | −4.2 ± 16.9 (P = 0.022) | ||
EQ-5D score | 0.03 ± 0.03 (−0.03 to 0.01) | 0.751 | ||
Baseline | 0.84 ± 0.21 | 0.85 ± 0.21 | ||
End point | 0.84 ± 0.23 | 0.85 ± 0.21 | ||
Baseline to end point change | −0.01 ± 0.23 (P = 0.628) | −0.01 ± 0.25 (P = 0.654) | ||
AADQ score | −1.6 ± 1.0 (−3.5 to 0.3) | 0.098 | ||
Baseline | 28.4 ± 7.2 | 28.5 ± 7.1 | ||
End point | 30.9 ± 7.3 | 30.5 ± 6.9 | ||
Baseline to end point change | 2.5 ± 7.7 (P = 0.002) | 2.0 ± 6.6 (P = 0.005) | ||
DTSQ score | 0.01 ± 1.34 (−2.63 to 2.65) | 0.997 | ||
Baseline | 21.6 ± 6.9 | 23.2 ± 7.1 | ||
End point | 24.6 ± 6.9 | 26.0 ± 6.9 | ||
Baseline to end point change | 3.0 ± 8.7 (P = 0.001) | 2.8 ± 7.8 (P = 0.001) | ||
SDSCA score | 0.2 ± 0.2 (−0.1 to 0.5) | 0.243 | ||
Baseline | 4.2 ± 1.1 | 4.3 ± 1.1 | ||
End point | 4.1 ± 1.1 | 4.3 ± 1.0 | ||
Baseline to end point change | −0.1 ± 1.1 (P = 0.504) | 0.0 ± 1.0 (P = 0.931) | ||
Glycemic control | ||||
HbA1c (%) | −0.3 ± 0.2 (−0.7 to 0.2) | 0.230 | ||
Baseline | 8.8 ± 1.7 | 8.7 ± 1.7 | ||
End point | 8.3 ± 1.7 | 7.9 ± 1.2 | ||
Baseline to end point change | −0.5 ± 2.0 (P = 0.018) | −0.7 ± 1.7 (P < 0.001) | ||
Inflammation-related biomarkers3,4,5 | ||||
hs-CRP (mg/dL) | −0.3 ± 0.1 (−0.5 to 0.0) | 0.061 | ||
Baseline | 0.2 (0.1; 0.5) | 0.1 (0.1; 0.4) | ||
End point | 0.2 (0.1; 0.4) | 0.2 (0.1; 0.3) | ||
Baseline to end point change | 0.0 (−0.1; 0.2) (P = 0.062) | 0.0 (−0.1; 0.1) (P = 0.283) | ||
IL-6 (pg/mL) | 0.0 ± 0.1 (−0.3 to 0.2) | 0.792 | ||
Baseline | 1.6 (0.8; 2.7) | 1.3 (0.8; 1.9) | ||
End point | 1.5 (1.0; 2.4) | 1.5 (1.0; 2.4) | ||
Baseline to end point change | 0.0 (−0.6; 0.4) (P = 0.780) | 0.1 (−0.6; 0.5) (P = 0.711) | ||
IL-1RA (pg/mL) | 0.0 ± 0.1 (−0.1 to 0.1) | 0.910 | ||
Baseline | 552.3 (340.8; 786.8) | 422.5 (300.0; 642.7) | ||
End point | 455.8 (333.7; 564.8) | 349.7 (246.0; 451.3) | ||
Baseline to end point change | −100.5 (−261.9; 28.8) (P = 0.001) | −70.8 (−171.8; 11.8) (P = 0.006) | ||
Adiponectin (ng/mL) | 0.0 ± 0.1 (−0.2 to 0.1) | 0.452 | ||
Baseline | 5,352.5 (3,443.0; 14,288.5) | 7,695.0 (4,384.0; 12,970.0) | ||
End point | 5,578.0 (4,062.0; 14,270.0) | 8,224.0 (5,187.0; 12,610.0) | ||
Baseline to end point change | 449.0 (−691.0; 1,818.7) (P = 0.529) | 738.0 (−802.0; 1,434.0) (P = 0.251) |
. | DIAMOS group (n = 93) . | CG (n = 88) . | Adjusted between-group change from baseline to end point . | Adjusted P values between groups . |
---|---|---|---|---|
Primary outcome—depressive symptoms1,2 | ||||
CES-D score | 3.9 ± 1.7 (0.6–7.3) | 0.021 | ||
Baseline | 24.4 ± 7.5 | 22.1 ± 8.6 | ||
End point | 17.0 ± 10.0 | 19.4 ± 11.8 | ||
Baseline to end point change | −7.4 ± 11.4 (P < 0.001) | −2.7 ± 11.7 (P = 0.036) | ||
Secondary outcomes1,2 | ||||
Psychological variables | ||||
PHQ-9 score | 1.7 ± 0.8 (0.2–3.2) | 0.023 | ||
Baseline | 10.9 ± 4.3 | 9.6 ± 3.8 | ||
End point | 7.5 ± 4.8 | 8.4 ± 5.0 | ||
Baseline to end point change | −3.3 ± 5.1 (P < 0.001) | −1.2 ± 5.7 (P = 0.050) | ||
WHO-5 score | −1.5 ± 0.9 (−3.2 to 0.3) | 0.097 | ||
Baseline | 8.2 ± 4.0 | 9.6 ± 4.9 | ||
End point | 12.7 ± 5.5 | 12.1 ± 6.1 | ||
Baseline to end point change | 4.5 ± 6.1 (P < 0.001) | 2.5 ± 6.3 (P < 0.001) | ||
DDS score | 0.3 ± 0.1 (0.1–0.5) | 0.012 | ||
Baseline | 2.8 ± 0.9 | 2.6 ± 0.8 | ||
End point | 2.1 ± 0.8 | 2.3 ± 0.8 | ||
Baseline to end point change | −0.7 ± 1.0 (P < 0.001) | −0.4 ± 0.7 (P < 0.001) | ||
PAID score | 8.2 ± 2.6 (3.1–13.3) | 0.002 | ||
Baseline | 41.1 ± 19.1 | 37.9 ± 17.5 | ||
End point | 28.1 ± 18.4 | 33.7 ± 19.7 | ||
Baseline to end point change | −13.0 ± 18.9 (P < 0.001) | −4.2 ± 16.9 (P = 0.022) | ||
EQ-5D score | 0.03 ± 0.03 (−0.03 to 0.01) | 0.751 | ||
Baseline | 0.84 ± 0.21 | 0.85 ± 0.21 | ||
End point | 0.84 ± 0.23 | 0.85 ± 0.21 | ||
Baseline to end point change | −0.01 ± 0.23 (P = 0.628) | −0.01 ± 0.25 (P = 0.654) | ||
AADQ score | −1.6 ± 1.0 (−3.5 to 0.3) | 0.098 | ||
Baseline | 28.4 ± 7.2 | 28.5 ± 7.1 | ||
End point | 30.9 ± 7.3 | 30.5 ± 6.9 | ||
Baseline to end point change | 2.5 ± 7.7 (P = 0.002) | 2.0 ± 6.6 (P = 0.005) | ||
DTSQ score | 0.01 ± 1.34 (−2.63 to 2.65) | 0.997 | ||
Baseline | 21.6 ± 6.9 | 23.2 ± 7.1 | ||
End point | 24.6 ± 6.9 | 26.0 ± 6.9 | ||
Baseline to end point change | 3.0 ± 8.7 (P = 0.001) | 2.8 ± 7.8 (P = 0.001) | ||
SDSCA score | 0.2 ± 0.2 (−0.1 to 0.5) | 0.243 | ||
Baseline | 4.2 ± 1.1 | 4.3 ± 1.1 | ||
End point | 4.1 ± 1.1 | 4.3 ± 1.0 | ||
Baseline to end point change | −0.1 ± 1.1 (P = 0.504) | 0.0 ± 1.0 (P = 0.931) | ||
Glycemic control | ||||
HbA1c (%) | −0.3 ± 0.2 (−0.7 to 0.2) | 0.230 | ||
Baseline | 8.8 ± 1.7 | 8.7 ± 1.7 | ||
End point | 8.3 ± 1.7 | 7.9 ± 1.2 | ||
Baseline to end point change | −0.5 ± 2.0 (P = 0.018) | −0.7 ± 1.7 (P < 0.001) | ||
Inflammation-related biomarkers3,4,5 | ||||
hs-CRP (mg/dL) | −0.3 ± 0.1 (−0.5 to 0.0) | 0.061 | ||
Baseline | 0.2 (0.1; 0.5) | 0.1 (0.1; 0.4) | ||
End point | 0.2 (0.1; 0.4) | 0.2 (0.1; 0.3) | ||
Baseline to end point change | 0.0 (−0.1; 0.2) (P = 0.062) | 0.0 (−0.1; 0.1) (P = 0.283) | ||
IL-6 (pg/mL) | 0.0 ± 0.1 (−0.3 to 0.2) | 0.792 | ||
Baseline | 1.6 (0.8; 2.7) | 1.3 (0.8; 1.9) | ||
End point | 1.5 (1.0; 2.4) | 1.5 (1.0; 2.4) | ||
Baseline to end point change | 0.0 (−0.6; 0.4) (P = 0.780) | 0.1 (−0.6; 0.5) (P = 0.711) | ||
IL-1RA (pg/mL) | 0.0 ± 0.1 (−0.1 to 0.1) | 0.910 | ||
Baseline | 552.3 (340.8; 786.8) | 422.5 (300.0; 642.7) | ||
End point | 455.8 (333.7; 564.8) | 349.7 (246.0; 451.3) | ||
Baseline to end point change | −100.5 (−261.9; 28.8) (P = 0.001) | −70.8 (−171.8; 11.8) (P = 0.006) | ||
Adiponectin (ng/mL) | 0.0 ± 0.1 (−0.2 to 0.1) | 0.452 | ||
Baseline | 5,352.5 (3,443.0; 14,288.5) | 7,695.0 (4,384.0; 12,970.0) | ||
End point | 5,578.0 (4,062.0; 14,270.0) | 8,224.0 (5,187.0; 12,610.0) | ||
Baseline to end point change | 449.0 (−691.0; 1,818.7) (P = 0.529) | 738.0 (−802.0; 1,434.0) (P = 0.251) |
1Baseline and end point data are shown as the mean ± SD; values for within-group baseline and end point changes are unadjusted differences.
2Values for between-group differences in baseline and end point changes, reported as the mean ± SEM (95% CI), are adjusted for BMI, diabetes type, macrovascular complications, baseline CES-D score, baseline PHQ-9 score, and baseline values.
3Baseline and end point data for inflammatory markers are shown as the median (interquartile range); values for within-group baseline and end point changes are unadjusted differences.
4Values for between-group differences in baseline and end point changes, reported as the mean ± SEM (95% CI), for inflammation-related biomarkers are adjusted for age, sex, BMI, diabetes type, diabetes duration, microvascular and macrovascular complications, intake of medications (statins, anticoagulants, thyroid medication, cortisone, and nonsteroidal anti-inflammatory drugs), baseline CES-D score, baseline PHQ-9 score, and baseline values.
5Statistical tests for inflammation-related biomarkers were performed with log-transformed values due to skewed distributions of the raw data.