Background
Methods
Study population
Outcomes for glucose metabolism and LV function
Clinical measurements of components of the metabolic syndrome
Laboratory tests
Statistical analysis
Results
Patients’ characteristics
Pre-existing diseases und medications
Verum (n = 29) | Placebo (n = 25) | V vs. P | |
---|---|---|---|
x ± SD | x ± SD | p-value | |
Sex (n/%) | |||
female | 14 (48.3%) | 13 (52.0%) | 1.000 |
male | 15 (51.7%) | 12 (48.0%) | |
Age (years) | 59.7 ± 10.2 | 59.8 ± 13.8 | 0.524 |
Height (cm) | 171.9 ± 8.8 | 171.0 ± 9.1 | 0.740 |
Weight (kg) | 82.0 ± 17.9 | 82.9 ± 14.7 | 0.561 |
BMI (kg/m2) | 27.6 ± 4.8 | 28.3 ± 4.2 | 0.535 |
< 25.0 kg/m2 (n/%) | 10 (34.5%) | 7 (28.0%) | 0.940 |
25.0–29.9 kg/m2 (n/%) | 11 (37.9%) | 11 (44.0%) | |
≥ 30.0 kg/m2 (n/%) | 8 (27.6%) | 7 (28.0%) | |
WC female (cm) | 88.9 ± 13.1 | 87.6 ± 9.6 | 0.847 |
≥ 88 cm (n/%) | 9 (31.0%) | 5 (20.0%) | 0.449 |
WC male (cm) | 103.6 ± 14.6 | 106.6 ± 8.8 | 0.286 |
≥ 102 cm (n/%) | 8 (27.6%) | 9 (36.0%) | 0.429 |
WHtR | 0.558 ± 0.080 | 0.565 ± 0.064 | 0.602 |
≥ 0,5 (n/%) | 21 (72.4%) | 20 (80.0%) | 0.545 |
BP systolic (mmHg) | 142.2 ± 17.4 | 134.7 ± 12.5 | 0.077 |
≥ 130 mmHg (n/%) | 23 (79.3%) | 16 (64.0%) | 0.239 |
BP diastolic (mmHg) | 86.3 ± 9.7 | 82.2 ± 8.6 | 0.160 |
≥ 85 mmHg (n/%) | 16 (55.2%) | 9 (36.0%) | 0.182 |
Heart rate/min | 71.4 ± 12.5 | 72.9 ± 12.7 | 0.773 |
Metabolic syndrome and its components
LV function
Verum (n = 29) x ± SD | Placebo (n = 25) x ± SD | |||||
---|---|---|---|---|---|---|
Baseline | Week 6 | Diff | Baseline | Week 6 | Diff | |
LA (mm) | 35.8 ± 5.9 | 37.1 ± 5.0 | 1.39 ± 2.92# | 36.4 ± 6.4 | 35.8 ± 6.1 | − 0.68 ± 4.26 |
RVEDD (mm) | 26.8 ± 5.3 | 26.3 ± 3.4 | − 0.52 ± 4.67 | 25.2 ± 4.1 | 25.1 ± 3.5 | − 0.08 ± 4.29 |
LVEDD (mm) | 49.0 ± 5.7 | 47.6 ± 7.1 | − 1.34 ± 5.47# | 47.9 ± 6.9 | 48.4 ± 7.5 | 0.52 ± 5.64 |
LVESD (mm) | 30.4 ± 4.9 | 30.1 ± 5.5 | − 0.31 ± 3.27 | 29.5 ± 5.2 | 30.2 ± 6.7 | 0.72 ± 4.20 |
LVEF (%) | 68.6 ± 8.3 | 70.2 ± 9.0 | 1.66 ± 8.94 | 70.0 ± 9.3 | 70.3 ± 8.9 | 0.28 ± 10.81 |
< 65% (n/%) | 10 (34.5%) | 9 (31.0%) | – | 6 (24.0%) | 7 (28.0%) | – |
< 65% | 59.5 ± 4.2 | 66.8 ± 9.5 | 7.30 ± 8.22# | 57.5 ± 5.4 | 64.5 ± 11.8 | 7.00 ± 7.75 |
≥ 65% | 73.5 ± 5.5 | 72.5 ± 8.4 | − 1.00 ± 8.07 | 74.0 ± 6.3 | 72.1 ± 7.3 | − 1.84 ± 10.93 |
IVS (mm) | 10.6 ± 1.6 | 9.9 ± 1.9 | − 0.62 ± 1.78 | 10.6 ± 1.4 | 10.2 ± 1.5 | − 0.44 ± 1.32 |
LVPW (mm) | 10.7 ± 1.6 | 10.3 ± 1.6 | − 0.41 ± 1.52 | 10.4 ± 1.5 | 10.2 ± 1.6 | − 0.20 ± 1.12 |
E/E´ > 8 (n/%) | 2 (25.0%) | 3 (37.5%) | – | 2 (33.3%) | 0 (0.0%) | – |
E wave | 0.73 ± 0.19 | 0.71 ± 0.16 | − 0.02 ± 0.18 | 0.73 ± 0.18 | 0.72 ± 0.15 | − 0.01 ± 0.15 |
A wave | 0.74 ± 0.24 | 0.68 ± 0.28 | − 0.06 ± 0.19 | 0.71 ± 0.18 | 0.73 ± 0.15 | 0.01 ± 0.16 |
E/A ratio | 1.05 ± 0.35 | 1.18 ± 0.49 | 0.13 ± 0.38# | 1.45 ± 2.04 | 1.02 ± 0.21 | − 0.42 ± 2.04 |
LVMI g/m2 | 98.2 ± 24.4 | 90.0 ± 37.0 | −8.15 ± 35.48## | 93.5 ± 26.5 | 90.9 ± 25.9 | −2.61 ± 21.20 |
LVMI g/m2 femalea | 87.2 ± 16.6 | 77.7 ± 20.9 | −9.5 ± 15.6# | 89.0 ± 26.2 | 80.2 ± 21.8 | −8.7 ± 23.1 |
LVMI g/m2 maleb | 108.4 ± 26.4 | 101.5 ± 45.1 | −6.9 ± 47# | 98.4 ± 27.1 | 102.4 ± 25.9 | 4.0 ± 17.5 |
total pANOVA | Depending variable: Regression coefficient B (p-value) | ||||
---|---|---|---|---|---|
LVMI Baseline | Serum-Mg Week 6 | Changing of | |||
Verum (n = 29) | 0,008 | 0,014 | 0,002 | HDL-C | −0,5671 (0,507) |
0,003 | 0,011 | 0,004 | BP diastolic | 1,6232 (0,129) | |
Placebo (n = 25) | 0,069 | 0,014 | 0,257 | HDL-C | 0,697 (0,283) |
0,109 | 0,020 | 0,421 | BP diastolic | −0,164 (0,780) |
HOMA-quartile | 1: 0.7 … 1.5 | 2: 1.6 … 2.4 | 3: 2.5 … 4.3 | 4: > 4.3 | p-value |
---|---|---|---|---|---|
N (male/female) | 7/7 | 5/8 | 5/9 | 10/3 | |
LVMI (male) | 96.1 +/− 36.8 | 106.2 +/− 23.2 | 102.9 +/− 35.9 | 108.9 +/− 16.4 | 0.372 |
LVMI (female) | 80.6 +/− 19.4 | 95.7 +/− 25.1 | 90.7 +/− 21.4 | 78.6 +/− 13.5 | 0.967 |
LA (male) | 37.3 +/− 7.6 | 38.0 +/− 7.2 | 37.0 +/− 4.8 | 41.4 +/− 4.2 | 0.118 |
LA (female) | 29.1 +/− 2.5 | 32.0 +/− 2.6 | 34.0 +/− 5.6 | 40.3 +/− 4.0 | 0.001 |
IVS (male) | 11.6 +/− 1.8 | 11.2 +/− 1.3 | 10.8 +/− 1.8 | 11.0 +/− 1.3 | 0.533 |
IVS (female) | 9.6 +/− 1.4 | 9.8 +/− 1.3 | 10.8 +/− 1.2 | 9.3 +/− 1.2 | 0.489 |
PW (male) | 11.3 +/− 1.9 | 11.4 +/− 1.5 | 11.0 +/− 2.0 | 11.3 +/− 1.4 | 0.880 |
PW (female) | 9.4 +/− 1.5 | 9.6 +/− 0.7 | 10.3 +/− 1.4 | 10.0 +/− 1.0 | 0.205 |
LVEDD (male) | 47.0 +/− 8.5 | 50.0 +/− 7.1 | 51.4 +/− 6.7 | 53.5 +/− 4.1 | 0.055 |
LVEDD (female) | 43.1 +/− 4.8 | 49.8 +/− 4.5 | 44.9 +/− 4.5 | 47.3 +/− 3.2 | 0.562 |
HOMA-IR
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 |
Other biochemistry cardiovascular risk factors
Rhythm disturbances
Verum (n = 29) x ± SD | Placebo (n = 25) x ± SD | |||||
---|---|---|---|---|---|---|
Baseline | Week 6 | Diff | Baseline | Week 6 | Diff | |
VPBs > 500/24 h | 2486 ± 2133 | 2316 ± 3232 | − 170 ± 2469 | 5717 ± 7662 | 2649 ± 3287 | − 3068 ± 5259## |
SV tachycardia (hr > 100/min) | 37.3 ± 66.1 | 23.7 ± 46.0 | − 13.6 ± 67.4 | 52.2 ± 67.3 | 39.9 ± 103.8 | − 12.4 ± 96.9 |
SVPBs > 200/24 h | 2000 ± 1874 | 2204 ± 1474 | 204 ± 1541 | 1025 ± 406 | 585 ± 786 | − 440 ± 427 |
SVPBs < 200/24 h with symptoms | 20.5 ± 32.9 | 21.3 ± 46.9 | 0.85 ± 55.83 | 39.2 ± 36.4* | 107.7 ± 298.0 | 68.6 ± 269.7 |
Heart rate (bpm) | 71.4 ± 12.5 | 68.4 ± 10.8 | − 3.0 ± 7.9# | 72.9 ± 12.7 | 70.3 ± 13.2 | −2.6 ± 9.3 |