Table 1. Effects of 12 weeks of treatment with BSE on clinical variables in T2D patients.

Data are means ± SD for patients with well-regulated (HbA1c ≤ 50 mmol/mol) and with dysregulated T2D (HbA1c > 50 mmol/mol) who are nonobese (BMI ≤ 30 kg/m2) or obese (BMI > 30 kg/m2). Data measured before treatment start (baseline) and after 12 weeks on placebo or BSE.

TreatmentPhenotypeTimeWell-regulated T2DDysregulated T2D
Nonobese (n = 28)Obese (n = 31)Nonobese (n = 21)Obese (n = 17)
PlaceboHbA1c (mmol/mol)Baseline46.4 ± 2.845.6 ± 3.454.6 ± 3.256.3 ± 7.5
12 weeks47.5 ± 4.146.3 ± 3.454.9 ± 4.456.6 ± 9.2
Fasting P-glucose (mM)Baseline7.51 ± 0.917.26 ± 0.868.84 ± 0.848.33 ± 1.03
12 weeks7.55 ± 0.847.29 ± 0.879.08 ± 1.318.91 ± 1.75
P-glucose 120 min (mM)Baseline13.77 ± 3.1611.55 ± 2.5817.00 ± 3.1415.81 ± 2.50
12 weeks13.27 ± 3.5811.22 ± 2.0217.10 ± 3.8215.28 ± 3.42
BMI (kg/m2)Baseline27.6 ± 1.933.3 ± 2.428.0 ± 1.333.1 ± 2.0
12 weeks27.8 ± 1.933.4 ± 2.528.1 ± 1.533.0 ± 2.1
HOMA-IR (mM × mU/liter)Baseline1.75 ± 0.782.73 ± 1.502.36 ± 1.524.32 ± 1.80
12 weeks1.83 ± 0.863.04 ± 2.102.52 ± 1.705.11 ± 3.30
ISIBaseline3.39 ± 1.592.47 ± 1.903.48 ± 2.691.60 ± 0.73
12 weeks3.70 ± 2.042.55 ± 2.083.41 ± 2.391.67 ± 0.79
Fatty liver indexBaseline60.2 ± 18.183.1 ± 13.958.0 ± 18.787.9 ± 10.8
12 weeks58.0 ± 17.781.2 ± 16.657.5 ± 22.287.9 ± 10.9
P-triglycerides (mM)Baseline1.49 ± 0.651.39 ± 0.561.50 ± 0.491.88 ± 0.89
12 weeks1.40 ± 0.671.26 ± 0.421.40 ± 0.551.94 ± 0.89
BSEHbA1c (mmol/mol)Baseline45.7 ± 3.246.1 ± 3.055.7 ± 6.057.1 ± 6.6
12 weeks46.9 ± 3.546.7 ± 2.757.3 ± 5.253.4 ± 6.8
Fasting P-glucose (mM)Baseline7.49 ± 1.167.34 ± 0.948.61 ± 1.418.58 ± 1.60
12 weeks7.91 ± 1.687.60 ± 1.368.39 ± 1.248.15 ± 1.26
P-glucose 120 min (mM)Baseline13.99 ± 4.2213.33 ± 3.8415.52 ± 3.2615.64 ± 3.63
12 weeks13.83 ± 4.2713.36 ± 3.1716.51 ± 3.0915.41 ± 3.61
BMI (kg/m2)Baseline28.1 ± 1.432.9 ± 1.827.8 ± 1.333.2 ± 2.1
12 weeks28.2 ± 1.433.4 ± 2.327.7 ± 1.333.1 ± 2.3
HOMA-IR (mM × mU/liter)Baseline1.76 ± 0.762.46 ± 1.422.32 ± 1.773.02 ± 1.34
12 weeks2.44 ± 0.883.08 ± 1.502.20 ± 1.623.05 ± 0.87
ISIBaseline2.78 ± 0.892.00 ± 0.844.08 ± 2.092.32 ± 1.03
12 weeks2.40 ± 1.001.92 ± 0.763.92 ± 1.982.28 ± 1.05
Fatty liver indexBaseline60.6 ± 18.783.2 ± 10.461.5 ± 18.887.7 ± 9.8
12 weeks62.9 ± 18.485.6 ± 10.362.4 ± 18.287.2 ± 7.6
P-triglycerides (mM)Baseline1.42 ± 0.641.35 ± 0.401.87 ± 1.331.50 ± 0.53
12 weeks1.46 ± 0.651.42 ± 0.422.10 ± 1.231.40 ± 0.48