| Verum (n = 29) x ± SD | Placebo (n = 25) x ± SD | ||||
---|---|---|---|---|---|---|
Baseline | Week 6 | Diff | Baseline | Week 6 | Diff | |
CrP (nmol/l) | 26.0 ± 28.7 | 24.8 ± 22.6 | −1.22 ± 23.37 | 20.8 ± 19.8 | 29.8 ± 42.1 | 9.07 ± 39.52 |
  < 10 nmol/l (n/%) | 9 (31.0%) | 9 (31.0%) | – | 10 (40.0%) | 12 (48.0%) | – |
 10–30 nmol/l (n/%) | 13 (44.8%) | 13 (44.8%) | 10 (40.0%) | 6 (24.0%) | ||
  > 30 nmol/l (n/%) | 7 (24.1%) | 7 (24.1%) | 5 (20.0%) | 7 (28.0%) | ||
FPG (mmol/l) | 5.49 ± 1.58 | 5.30 ± 1.28 | − 0.20 ± 0.75 | 5.35 ± 0.65 | 5.15 ± 0.77 | −0.20 ± 0.63# |
  < 5.6 mmol/l | 4.76 ± 0.54 | 4.79 ± 0.62 | 0.03 ± 0.39 | 5.04 ± 0.27 | 4.91 ± 0.70 | − 0.13 ± 0.58 |
  ≥ 5.6 mmol/l | 7.12 ± 1.94 | 6.42 ± 1.67 | −0.70 ± 1.10 | 6.15 ± 0.65 | 5.79 ± 0.56 | −0.36 ± 0.75 |
HbA1c (%) | 5.77 ± 0.68 | 5.76 ± 0.63 | −0.01 ± 0.35 | 5.64 ± 0.39 | 5.66 ± 0.33 | 0.02 ± 0.39 |
F Insulin (pmol/l)a | 113.9 ± 127.5 | 89.5 ± 75.8 | − 24.4 ± 73.4 | 83.6 ± 44.9 | 71.3 ± 51.3 | −12.3 ± 54.0 |
  < 58 pmol/l (n/%) | 10 (34.5%) | 11 (37.9%) | – | 8 (32.0%) | 10 (40.0%) | – |
  < 58 pmol/l | 39.2 ± 9.9 | 44.7 ± 18.4 | 5.2 ± 19.5 | 41.3 ± 13.5 | 40.4 ± 13.3 | − 0.9 ± 16.0 |
  ≥ 58 pmol/l | 153.1 ± 143.2 | 113.1 ± 84.0 | −39.9 ± 86.3# | 103.5 ± 40.0 | 85.9 ± 56.3 | − 17.7 ± 64.6 |
HOMA-IRa | 4.93 ± 9.18 | 3.39 ± 4.00 | − 1.54 ± 5.69# | 2.97 ± 1.86 | 2.50 ± 2.17 | −0.47 ± 2.26 |
  ≤ 2.5 (n/%) | 15 (51.7%) | 20 (69.0%) | – | 14 (56.0%) | 18 (72.0%) | – |
  ≤ 2.5 | 1.55 ± 0.52 | 1.57 ± 0.59 | 0.03 ± 0.56 | 1.66 ± 0.52 | 1.95 ± 2.19 | 0.29 ± 2.02 |
  > 2.5 | 8.56 ± 12.40 | 5.34 ± 5.12 | − 3.22 ± 7.97 | 4.64 ± 1.60 | 3.20 ± 2.03 | −1.44 ± 2.28 |
Na (mmol/l) | 143.0 ± 4.5 | 142.2 ± 2.7 | −0.76 ± 4.25 | 141.9 ± 2.5 | 141.6 ± 2.8 | −0.28 ± 2.51 |
  < 140 mmol/l | 138.0 ± 1.2 | 139.0 ± 3.5 | 1.00 ± 2.83 | 138.4 ± 0.9 | 138.8 ± 4.4 | 0.40 ± 4.22 |
  ≥ 140 mmol/l | 143.8 ± 4.3 | 142.8 ± 2.2 | − 1.04 ± 4.41 | 142.8 ± 2.0 | 142.4 ± 1.7 | − 0.45 ± 2.01 |
K (mmol/l) | 4.44 ± 0.53 | 4.55 ± 0.43 | 0.11 ± 0.44 | 4.59 ± 0.37 | 4.50 ± 0.31 | −0.09 ± 0.33* |
  < 4.0 mmol/l | 3.72 ± 0.17 | 4.08 ± 0.34 | 0.35 ± 0.26 | 3.70 | 4.10 | 0.40 |
  ≥ 4.0 mmol/l | 4.56 ± 0.47 | 4.62 ± 0.40 | 0.07 ± 0.45 | 4.63 ± 0.33 | 4.52 ± 0.31 | − 0.11 ± 0.32 |
Mg (mmol/l) | 0.845 ± 0.069 | 0.858 ± 0.068 | 0.013 ± 0.047 | 0.874 ± 0.084 | 0.851 ± 0.068 | −0.024 ± 0.056#** |
  < 0.75 mmol/l | 0.727 ± 0.023 | 0.773 ± 0.021 | 0.048 ± 0.035 | 0.72 | 0.77 | 0.05 |
  ≥ 0.75 mmol/l | 0.859 ± 0.058 | 0.867 ± 0.068 | 0.009 ± 0.047 | 0.881 ± 0.079 | 0.854 ± 0.068 | − 0.027 ± 0.055##** |
Cl (mmol/l) | 102.0 ± 3.4 | 100.9 ± 2.6 | −1.03 ± 3.80 | 101.4 ± 2.6 | 101.4 ± 3.2 | 0.00 ± 3.20 |
  < 100 mmol/l | 98.0 ± 1.2 | 99.6 ± 2.4 | 1.57 ± 2.51 | 97.8 ± 1.0 | 100.2 ± 2.5 | 2.33 ± 2.88 |
  ≥ 100 mmol/l | 103.2 ± 2.8 | 101.4 ± 2.5 | −1.86 ± 3.81# | 102.6 ± 1.8 | 101.8 ± 3.4 | −0.74 ± 3.00 |
Creatinine (μmol/l) | 77.4 ± 14.6 | 76.4 ± 14.9 | −0.95 ± 6.98 | 76.6 ± 17.4 | 75.3 ± 16.4 | −1.31 ± 7.02 |
GFR (ml/min) | 83.6 ± 13.9 | 85.4 ± 14.9 | 1.79 ± 8.09 | 86.1 ± 16.0 | 86.8 ± 16.3 | 0.76 ± 6.48 |
TC (mmo/l) | 4.97 ± 1.00 | 5.12 ± 1.09 | 0.15 ± 0.66 | 5.25 ± 0.94 | 5.10 ± 1.04 | −0.15 ± 0.69 |
  ≥ 5.2 mmol/l | 5.74 ± 0.63 | 6.08 ± 0.79 | 0.34 ± 0.85 | 5.86 ± 0.75 | 5.89 ± 0.67 | 0.03 ± 0.37 |
LDL-C (mmol/l) | 3.14 ± 0.97 | 3.10 ± 0.83 | − 0.04 ± 0.44 | 3.39 ± 0.92 | 3.30 ± 0.97 | −0.09 ± 0.45 |
  < 2.6 mmol/l | 2.02 ± 0.27 | 2.27 ± 0.48 | 0.25 ± 0.45 | 2.11 ± 0.56 | 2.33 ± 0.32 | 0.22 ± 0.25 |
  ≥ 2.6 mmol/l | 3.59 ± 0.76 | 3.43 ± 0.70 | −0.15 ± 0.40 | 3.64 ± 0.76 | 3.48 ± 0.94 | −0.15 ± 0.46 |
  < 3.3 mmol/l | 2.43 ± 0.48 | 2.59 ± 0.51 | 0.16 ± 0.36 | 2.72 ± 0.57* | 2.67 ± 0.40 | − 0.05 ± 0.33 |
  ≥ 3.3 mmol/l | 4.08 ± 0.55 | 3.78 ± 0.68 | − 0.30 ± 0.41# | 4.01 ± 0.71 | 3.88 ± 0.99 | − 0.14 ± 0.54 |
HDL-C (mmol/l) | 1.40 ± 0.41 | 1.39 ± 0.43 | −0.01 ± 0.17 | 1.45 ± 0.47 | 1.40 ± 0.42 | −0.05 ± 0.17 |
TG (mmol/l) | 1.56 ± 0.77 | 1.97 ± 1.86 | 0.42 ± 1.30# | 1.34 ± 0.53 | 1.36 ± 0.50 | 0.02 ± 0.58 |
  ≥ 1.7 mmol/l | 2.63 ± 0.57 | 3.71 ± 2.95 | 1.08 ± 2.41 | 2.08 ± 0.28* | 1.71 ± 0.61 | −0.37 ± 0.76 |
Uric acid (μmol/l) | 338 ± 90 | 331 ± 80 | − 7.2 ± 42.1 | 315 ± 100 | 308 ± 91 | − 6.9 ± 39.9 |
Gamma-GT (μkat/l) | 0.64 ± 0.83 | 0.63 ± 0.72 | −0.01 ± 0.17 | 0.53 ± 0.29 | 0.52 ± 0.26 | −0.01 ± 0.17 |
ASAT (μkat/l) | 0.42 ± 0.20 | 0.42 ± 0.11 | 0.00 ± 0.14 | 0.40 ± 0.11 | 0.40 ± 0.13 | 0.00 ± 0.09 |
ALAT (μkat/l) | 0.47 ± 0.24 | 0.46 ± 0.21 | − 0.02 ± 0.16 | 0.43 ± 0.26 | 0.45 ± 0.28 | 0.02 ± 0.11 |
TSH (μIU/ml) | 2.15 ± 1.17 | 1.96 ± 1.06 | −0.19 ± 0.52# | 2.19 ± 1.20 | 1.92 ± 1.00 | −0.28 ± 0.57# |
24 h urinary collection | ||||||
 Na (mmol/24 h) | 193.7 ± 73.6 | 186.7 ± 76.0 | −7.0 ± 79.7 | 167.9 ± 53.5 | 177.4 ± 64.1 | 9.5 ± 46.8 |
 K (mmol/24 h) | 68.2 ± 25.3 | 76.6 ± 26.2 | 8.4 ± 28.0 | 67.3 ± 19.3 | 71.6 ± 22.5 | 4.2 ± 18.0 |
 K i.S./K (24 h) | 0.072 ± 0.023 | 0.067 ± 0.027 | − 0.005 ± 0.028 | 0.076 ± 0.034 | 0.069 ± 0.021 | −0.008 ± 0.030 |
 Mg (mmol/24 h) | 4.03 ± 1.14 | 4.79 ± 1.79 | 0.76 ± 1.85# | 3.78 ± 1.45 | 3.86 ± 1.88 | 0.08 ± 1.75* |
 Mg i.S./Mg (24 h) | 0.227 ± 0.070 | 0.221 ± 0.162 | −0.006 ± 0.180 | 0.260 ± 0.095 | 0.268 ± 0.121 | 0.008 ± 0.093 |
 Cl (mmol/24 h) | 175.6 ± 70.2 | 174.9 ± 76.9 | −0.72 ± 74.63 | 153.5 ± 54.9 | 161.2 ± 70.7 | 7.72 ± 43.40 |
 Albumin (mg/24 h) | 10.8 ± 19.2 | 12.0 ± 26.4 | 1.17 ± 15.42 | 9.5 ± 17.2 | 11.7 ± 18.8 | 2.24 ± 5.88 |
 Albumin/crea (24 h) | 0.82 ± 1.40 | 0.80 ± 1.36 | −0.02 ± 0.36 | 0.77 ± 1.31 | 0.96 ± 1.55 | 0.20 ± 0.48 |