Table 4.
Delta changes in the explorative measurements from baseline to follow up time point
| n | Control ∆adj | n | Intervention ∆adj | n | Intervention effect ∆adj | P value | |
|---|---|---|---|---|---|---|---|
| Glycemic control | |||||||
| HbA1c (mmol/mol) | 12 | -0.3 (-0.8; 0.1) | 14 | -0.5 (-0.9; -0.1) | 26 | -0.2 (-0.8; 0.5) | 0.6 |
| Oral glucose tolerance test | |||||||
| Fasting glucose (mmol/L) | 14 | 0.1 (-0.1;0.3) | 14 | 0.1 (-0.1; 0.2) | 28 | 0.0 (-0.3; 0.3) | 0.4 |
| Fasting insulin (mmol/L) | 13 | -4.7 (-17.6; 8.2) | 12 | -13.4 (-26.7; -0.1) | 25 | -8.7 (-27.4; 10.0) | 0.3 |
| 120 min (2 h) glucose (mmol/L) | 10 | 0.6 (-0.1; 1.3) | 13 | 0.1 (-0.5; 0.7) | 23 | -0.5 (-1.4; 0.4) | 0.3 |
| Matsuda Index | 9 | -3.4 (-10.2; 3.5) | 12 | 7.4 (1.9; 13.0) | 21 | 10.8 (1.4; 20.2) | P <0.03 |
| HOMA-IR | 13 | 0.1 (-0.5; 0.3) | 12 | -0.4 (-0.8; 0.1) | 25 | -0.3 (-0.9; 0.3) | 0.3 |
| Mean 48 h BG (mmol/L) by CGMS | 7 | 0.1 (-0.6; 0.9) | 9 | -0.3 (-1.0; 0.4) | 16 | -0.4 (-1.5; 0.7) | 0.4 |
| Biochemistry | |||||||
| Alanintransaminase (U/l) | 12 | -7.9 (-12.6; -3.3) | 14 | -9.1 (-13.3; -4.8) | 26 | -1.1 (-7.4; 5.2) | 0.7 |
| Aspartattransaminase (U/l) | 12 | -2.0 (-5.1; 1.1) | 14 | -2.9 (-5.8; 0.0) | 26 | -0.9 (-5.1; 3.3) | 0.7 |
| Thyrotropin (x10-3int.enh./l) | 14 | 0.1 (-0.4; 0.6) | 14 | 0.3 (-0.1; 0.8) | 28 | 0.2 (-0.5; 0.9) | 0.5 |
| Triiodthyronin (nmol/l) | 14 | -0.2 (-0.3; 0.0) | 14 | -0.2 (-0.4; -0.1) | 28 | -0.1 (-0.3; 0.1) | 0.5 |
| Thyroxin (nmol/l) | 14 | 0.8 (-3.9; 5.5) | 14 | -0.6 (-5.3; 4.1) | 28 | -1.4 (-8.0; 5.3) | 0.7 |
| Total cholesterol (mmol/L) | 14 | -0.3 (-0.5; 0.0) | 14 | -0.5 (-0.8; -0.3) | 28 | -0.3 (-0.6; 0.0) | 0.07 |
| LDL (mmol/L) | 14 | -0.1 (-0.3; 0.1) | 14 | -0.4 (-0.6; -0.2) | 28 | -0.3 (-0.6; 0.0) | 0.06 |
| HDL (mmol/L) | 14 | 0.1 (0.0; 0.1) | 14 | 0.0 (-0.1; 0.1) | 28 | -0.1 (-0.2; 0.1) | 0.4 |
| Triglycerides (mmol/L) | 14 | -0.1 (-0.2; 0.0) | 14 | -0.3 (-0.4; -0.1) | 28 | -0.2 (-0.3; 0.0) | 0.1 |
| Estradiol (pmol/L) | 13 | -11.8 (-22.4; -1.2) | 13 | -14.8 (-25.5; -4.1) | 26 | -3.0 (-18.6; 12.5) | 0.7 |
| Testosterone (nmol/L) | 12 | 0.0 (0.0; 0.1) | 13 | 0.0 (0.0; 0.1) | 25 | 0.00 (-0.1; 0.1) | 1 |
| Sex hormone-binding globulin (nmol/L) | 13 | 4.2 (-2.4; 10.8) | 13 | 17.0 (10.5; 23.5) | 26 | 12.9 (3.5; 22.3) | P <0.01 |
| Follicle-stimulating hormone (IU/L) | 13 | 0.1 (-0.2; 0.3) | 13 | 0.0 (-0.3; 0.2) | 26 | -0.1 (-0.4; 0.3) | 0.7 |
| Luteinizing hormone (IU/L) | 13 | 0.0 (-0.1; 0.3) | 13 | 0.0 (-0.2; 0.2) | 26 | -0.1 (-0.3; 0.2) | 0.5 |
| IGFBP-3 (ng/mL) | 13 | -73.2 (-233.5; 87.0) | 13 | -124.5 (-291.0; 42.0) | 26 | -51.3 (-293.0; 190.4) | 0.7 |
| Insulin-like growth factor 1 (ng/mL) | 13 | 49.8 (15.1; 84.5) | 13 | 4.4 (-30.2; 39.1) | 26 | -45.4 (-94.5; 3.8) | 0.07 |
| Adiponectin (ng/mL) | 12 | -1,693 (-3,143; -242) | 13 | 595 (-801; 1,990) | 25 | 2,287 (254; 4,320) | P <0.05 |
| Leptin (pg/mL) | 11 | -7,803 (-15,402; -205) | 14 | -14,374 (-21,069; -7,679) | 25 | -6,570 (-16,944; 3,803) | 0.2 |
| Resistin (ng/mL) | 12 | -0.4 (-0.9; 0.1) | 14 | -0.6 (-1.0; -0.1) | 26 | -0.2 (-0.8; 0.5) | 0.6 |
| Visfatin (ng/mL) | 10 | 0.0 (-0.3; 0.2) | 11 | 0.2 (-0.1; 0.4) | 21 | 0.2 (-0.2; 0.5) | 0.3 |
P values are representing the intervention effects (the difference in change between the groups) adjusted for the respective baseline values (95% confidence intervals).
P values assessed by ANCOVA.
Mean 48 h BG (mmol/L) by CGMS, mean blood glucose measured in 48 h by continuous glucose monitoring system.
HbA1c, glycosylated hemoglobin; HDL, high-density lipoprotein; LDL, low-density lipoprotein; IGFBP-3, Insulin-like growth factor-binding protein 3.