Introduction
Methods
Patients
Study Design
Study Procedures
Measurements and Calculations
Statistical Analysis
Results
Reduction of HbA1c and Changes of Insulin Sensitivity
Whole group (n = 68) | Lean group (n = 31) | Obese group (n = 37) | |||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | 16th week | Changes | Baseline | 16th week | Changes | Baseline | 16th week | Changes | |
HbA1c (%) | 7.6 ± 1.2 | 6.4 ± 0.6 | − 1.3 ± 1.1a | 7.7 ± 1.0 | 6.4 ± 0.5 | − 1.2 ± 0.2a | 7.6 ± 1.3 | 6.4 ± 0.6 | − 1.3 ± 0.2a |
FPG (mmol/L) | 8.6 ± 1.9 | 6.1 ± 0.7 | − 2.7 ± 2.0a | 8.7 ± 2.0 | 5.9 ± 0.7 | − 3.0 ± 0.4a | 8.6 ± 1.8 | 6.1 ± 0.7 | − 2.5 ± 0.4a |
2hPG (mmol/L) | 13.8 ± 2.9 | 7.8 ± 1.5 | − 6.8 ± 0.5a | 13.1 ± 2.6 | 7.7 ± 1.6 | − 6.0 ± 0.6a | 14.3 ± 3.1 | 7.9 ± 1.3 | − 7.7 ± 0.6a |
GIR (mg/kg/min) | 5.0 (3.9–6.6) | 7.1 (6.2–9.8) | 2.0 (0.9–3.8)a | 6.1 (4.8–7.0) | 7.7 (6.7–11.1) | 1.5 (0.8–4.4)a | 4.4 (3.5–5.7) | 6.7 (5.9–9.5) | 2.4 (1.6–3.7)a |
AIR (µU/ml/min) | 37.5 (21.5–54.1) | 69.1 (43.8–126.1) | 28.3 (11.1–65.7)a | 23.4 (20.9–48.8) | 52.2 (33.4–77.7) | 17.6 (8.9–41.1)a | 42.0 (27.3–85.5) | 109.2 (56.0–159.6) | 57.5 (27.1–90.8)a |
DI (mg × µU/kg/mL) | 155.3 (118.5–343.9) | 506.7 (299.8–1105.4) | 305.4 (157.0–746.1)a | 149.8 (107.6–327.5) | 411.1 (221.0–955.2) | 164.4 (85.2–433.4)a | 160.6 (118.5–394.0) | 712.8 (389.8–1316.9) | 472.5 (297.9–1108.1)a,d |
Ratio AUC-I/G | 0.3 (0.1–0.5) | 0.5 (0.3–1.0) | 0.2 (0.1–0.5)b | 0.2 (0.1− 0.3) | 0.4 (0.2–0.6) | 0.2 (0.1–0.3)b | 0.4 (0.2–0.7) | 0.9 (0.4–1.4) | 0.3 (0.1–0.6)b |
Leptin (ng/mL) | 2.4 (1.1–6.6) | 2.8 (1.0–8.5) | 0.2 (− 1.54 to 2.7) | 1.9 (0.9–5.4) | 2.6 (0.8–8.5) | 1.0 (− 1.7 to 3.5) | 3.0 (1.6–7.8) | 2.4 (0.7–6.8) | − 0.7 (− 1.8 to 1.3) |
APN (µg/mL) | 9.8 (5.7–21.1) | 25.2 (11.3–52.4) | 12.6 (− 2.7 to 38.3)c | 14.1 (8.1–30.3) | 28.9 (12.2–58.6) | 10.2 (− 14.8 to 40.4) | 8.4 (5.0–11.5) | 22.3 (10.9–42.5) | 12.6 (2.0–32.2)c |
hs-CRP (ng/mL) | 1.8 (1.0–3.0) | 1.3 (0.7–2.5) | − 0.3 (− 1.7 to 0.9) | 1.8 (1.0–3.3) | 1.9 (0.7–2.8) | − 0.3 (− 1.5 to 1.1) | 1.8 (1.2–2.9) | 1.3 (0.7–2.4) | − 0.3 (− 1.7 to 0.6) |
Improvements of Pancreatic β-Cell Function
Effects of PIO-Induced Improvement of Insulin Sensitivity and β-Cell Function on Reduction of HbA1c
Variable | Estimate | SE | P Value |
---|---|---|---|
Intercept | 0.00521 | 0.12575 | 0.9671 |
Change_GIR | − 0.26663a | 0.12610 | 0.0397 |
Change_Ratio AUC-I/G | − 0.39765a | 0.12654 | 0.0029 |
Variable entered | Partial R2 | Model R2 | F Value | P Value |
---|---|---|---|---|
Change_GIR | 0.0681 | 0.2688 | 4.47 | 0.0397 |
Change_ratio AUC-I/G | 0.2007 | 0.2007 | 12.30 | 0.0010 |
Changes of APN, hs-CRP, and Leptin
Safety and Adverse Events
Whole group (n = 68) | Lean group (n = 31) | Obese group (n = 37) | |||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | 16th week | Changes | Baseline | 16th week | Changes | Baseline | 16th week | Changes | |
BMI (kg/m2) | 25.6 ± 3.7 | 25.5 ± 3.6 | − 0.2 ± 1.3 | 22.5 ± 1.6 | 22.5 ± 2.0 | 0.04 ± 0.9 | 28.3 ± 2.8 | 27.9 ± 2.6 | − 0.4 ± 1.5 |
Weight (kg) | 69.5 ± 12.2 | 69.1 ± 11.8 | − 0.6 ± 3.3 | 60.3 ± 8.5 | 60.8 ± 9.2 | 0.1 ± 2.3 | 77.4 ± 9.0 | 76.0 ± 9.0 | − 1.1 ± 3.9 |
SBP (mmHg) | 124.8 ± 12.9 | 122.2 ± 12.5 | − 2.5 ± 10.9 | 122.7 ± 14.0 | 120.7 ± 13.7 | − 3.4 ± 11.9 | 126.6 ± 11.8 | 123.9 ± 11.3 | − 1.7 ± 10.0 |
DBP (mmHg) | 77.3 ± 9.5 | 74.6 ± 8.4 | − 2.7 ± 9.3 | 75.2 ± 10.4 | 74.4 ± 7.8 | − 1.6 ± 9.8 | 79.2 ± 8.3 | 74.5 ± 9.2 | − 3.7 ± 8.9a |
TG (mmol/L) | 1.8 ± 1.2 | 1.7 ± 1.5 | − 0.1 ± 1.0 | 1.5 ± 0.8 | 1.3 ± 0.6 | − 0.3 ± 0.8 | 2.1 ± 1.4 | 2.0 ± 1.9 | − 0.1 ± 1.3 |
TC (mmol/L) | 4.8 ± 1.0 | 4.7 ± 0.9 | − 0.2 ± 1.1 | 4.8 ± 1.1 | 4.6 ± 0.7 | − 0.4 ± 1.7 | 4.9 ± 0.9 | 4.8 ± 1.1 | − 0.0 ± 1.0 |
HDL-c (mmol/L) | 1.1 ± 0.3 | 1.2 ± 0.3 | 0.1 ± 0.2 | 1.1 ± 0.4 | 1.2 ± 0.3 | 0.1 ± 0.2 | 1.1 ± 0.2 | 1.2 ± 0.3 | 0.1 ± 0.2 |
LDL-c (mmol/L) | 3.0 ± 0.8 | 3.0 ± 0.7 | − 0.04 ± 0.7 | 3.0 ± 0.9 | 2.8 ± 0.5 | − 0.1 ± 0.5 | 3.0 ± 0.7 | 3.0 ± 0.8 | 0.0 ± 0.9 |
ALT (IU/L) | 24.7 ± 13.0 | 16.7 ± 6.6 | − 6.5 ± 9.5a | 21.7 ± 14.3 | 14.8 ± 5.1 | − 4.3 ± 6.1a | 27.2 ± 11.6 | 18.2 ± 7.3 | − 7.8 ± 11.2a |
AST (IU/L) | 22.6 ± 9.2 | 18.2 ± 5.5 | − 3.4 ± 7.7a | 21.8 ± 11.4 | 18.0 ± 4.3 | − 1.7 ± 6.1a | 23.2 ± 7.0 | 18.4 ± 6.5 | − 5.0 ± 8.7a |
Cr (µmol/L) | 67.5 ± 17.2 | 68.2 ± 17.1 | 0.9 ± 17.4 | 65.3 ± 16.1 | 69.1 ± 18.7 | 3.0 ± 22.6 | 69.3 ± 18.0 | 67.5 ± 16.0 | − 0.9 ± 11.8 |
BUN (mmol/L) | 5.2 ± 1.5 | 5.7 ± 1.4 | 0.7 ± 1.2 | 5.5 ± 1.7 | 5.9 ± 1.5 | 0.7 ± 1.1 | 5.0 ± 1.4 | 5.6 ± 1.3 | 0.6 ± 1.3 |
Anemia % (n) | 0 | 5.9% (4) | 0 | 9.7% (3) | 0 | 2.7% (1) | |||
Edema % (n) | 0 | 13.2% (9) | 0 | 12.9% (4) | 0 | 13.5% (5) |