Table 1

Baseline and 6-month primary and secondary outcome measures in the two study groups

CRSD
Baseline6 monthsBaseline6 monthsP value
Anthropometric variables
 Waist circumference (cm)104.1 (9.4)98.2 (10.7)**102.3 (10.2)100.7 (9.9)*<0.0001
 Weight (kg)87.2 (13.7)82.5 (13.2)**83.4 (15.0)82.8 (14.7)°0.0001
 BMI (kg/m2)30.0 (3.9)28.4 (3.8)**29.6 (3.8)29.3 (3.7)°<0.0001
  BMI <30 kg/m227.1 (1.7)25.9 (1.9)°°27.0 (2.0)26.8 (2.0)0.0065
  BMI ≥30 kg/m233.7 (2.4)31.6 (3.0)*32.7 (2.9)32.5 (2.7)0.0064
Clinical parameters
 BP (mmHg)
  Systolic127.8 (9.7)121.1 (9.9)°°129.3 (9.1)126.1 (8.6)°0.0322
  Diastolic80.5 (7.1)75.3 (7.1)**79.6 (7.3)77.6 (7.3)0.0349
 MAP (mmHg)96.3 (6.9)90.6 (7.5)**96.2 (7.3)93.8 (7.1)°0.0222
 HR (bpm)68.2 (8.8)63.7 (8.6)°°67.0 (8.7)66.7 (7.8)0.0094
Metabolic variables
 GDR (mg/kg/min)6.1 (2.3)7.9 (3.1)°°6.4 (2.0)6.6 (2.2)0.0075
 Blood glucose (mg/dL)138.9 (26.0)120.8 (26.9)**141.6 (25.6)148.6 (41.5)0.0004
 HbA1c (mmol/mol, IFCC)50.7 (11.1)44.9 (7.6)**48.4 (8.1)51.3 (10.9)°<0.0001
 HbA1c (%, NGSP)6.8 (1.0)6.3 (0.7)**6.6 (0.7)6.8 (1.0)°<0.0001
 Fasting insulin (μIU/L)^7.3 (3.4)6.5 (5.4)7.8 (4.6)8.7 (4.6)0.3738
Lipids
 Cholesterol
  Total (mg/dL)171.2 (27.1)167.3 (27.3)171.4 (29.4)172.8 (35.1)0.3384
  HDL (mg/dL)41.0 (11.3)43.4 (10.8)°41.8 (11.2)41.0 (10.9)0.0501
  LDL (mg/dL)106.9 (26.1)103.4 (27.8)°105.8 (30.5)106.8 (32.0)0.3718
  LDL-to-HDL ratio2.8 (0.97)2.5 (0.91)*2.6 (0.83)2.7 (0.96)0.0234
 Triglycerides (mg/dL)99.0 (35.7)85.4 (34.3)°117.8 (70.0)132.1 (126.3)0.1182
 Apolipoprotein A (mg/dL)136.2 (19.6)135.0 (15.9)136.9 (16.8)132.2 (21.8)0.2030
 Apolipoprotein B (mg/dL)84.3 (17.6)79.9 (18.6)86.4 (19.2)86.4 (20.9)0.1278
Other markers
 hs-CRP (mg/dL)0.32 (0.28)0.20 (0.20)*0.25 (0.33)0.27 (0.34)0.0164
 AST (IU/L)22.6 (4.1)20.2 (3.5)**22.7 (5.4)25.7 (17.7)0.0067
 ALT (IU/L)26.0 (7.8)21.9 (6.4)**26.2 (10.3)34.2 (47.2)0.0089
 CPK (IU/L)149.0 (141.4)123.0 (67.9)132.1 (89.5)113.5 (73.2)°0.798
 Angiotensin II (pg/mL)4.6 (3.5)3.5 (2.9)4.0 (2.7)5.0 (4.2)0.0421
 Urea (mg/dL)37.6 (8.3)39.5 (8.7)38.8 (9.4)39.0 (7.7)0.3930
Kidney function
 GFR (mL/min)
  Overall107.8 (21)100.2 (16.5)°°109.2 (19)106.5 (20.2)0.0472
  Hyperfiltering134.4 (8.7)118.1 (8.5)*130.9 (8.8)123.8 (13.2)0.245
  Nonhyperfiltering96.7 (12.9)92.7 (12.9)°99.4 (13.2)98.6 (17.9)0.237
  BMI <30 kg/m299.5 (18.6)95.2 (15.7)°104.1 (17.3)104.4 (18.4)0.079
  BMI ≥30 kg/m2118.2 (19.6)106.4 (15.8)*115.1 (19.7)108.9 (22.6)0.279
 UAE (mg/min)#5.1 (2.7)4.4 (2.4)°4.5 (2.7)4.3 (2.3)0.268
  • Data are mean (SD).

  • ALT, alanine aminotransferase; AST, aspartate transaminase; CPK, creatine phosphokinase; MAP, mean arterial pressure.

  • ‡Normal range: 25.0–28.9 mmol/mol or 4.4–5.7%;

  • †Changes in the CR compared with the SD group at 6 months after adjustment for baseline values by ANCOVA;

  • ^Analysis excluded patients receiving long-acting insulin therapy;

  • °P < 0.05;

  • *P ≤ 0.01;

  • °°P ≤ 0.001;

  • **P ≤ 0.0001 vs. baseline within the same treatment group;

  • #Log-transformed.