Table 2

Change in anthropometric and metabolic measures from baseline to 1 year

ILIUsual careEffectP
Weight, kg−3.8 (−4.6 to −3.0)1.4 (0.6 to 2.2)−5.2 (−6.4 to −4)<0.0001
Weight, %−4.4 (−5.4 to −3.5)1.6 (0.7 to 2.6)−6 (−7.4 to −4.7)<0.0001
BMI, kg/m2−1.6 (−2 to −1.3)0.6 (0.2 to 0.9)−2.2 (−2.7 to −1.7)<0.0001
Body fat, %−1.9 (−2.9 to −1.0)0.4 (−0.7 to 1.4)−2.3 (−3.8 to −0.9)0.002
Waist circumference, cm−3.3 (−5.2 to −1.4)−0.2 (−2.1 to 1.7)−3.1 (−5.8 to −0.5)0.02
Systolic blood pressure, mmHg−1.5 (−5.0 to 2.1)0 (−3.6 to 3.6)−1.4 (−6.0 to 3.1)0.53
Diastolic blood pressure, mmHg−0.5 (−2.8 to 1.7)−0.9 (−3.2 to 1.4)0.4 (−2.6 to 3.3)0.80
Metabolic profile
 Fasting glucose, mg/dL (mmol/L)−3.5 (−6.2 to −0.8) (−0.19 [−0.34 to −0.04])−4.5 (−7.2 to −1.8) (−0.25 [−0.39 to −0.1])0.9 (−2.7 to 4.6) (0.05 [−0.15 to 0.26])0.61
 2-h glucose, mg/dL (mmol/L)−18.9 (−29 to −8.8) (−1.05 [−1.61 to −0.49])−5.5 (−15.7 to 4.7) (−0.31 [−0.87 to 0.26])−13.4 (−27.1 to 0.3) (−0.74 [−1.5 to 0.02])0.055
 2-h glucose excursion, mg/dL (mmol/L)−15.3 (−25.1 to −5.6) (−0.85 [−1.39 to −0.31])−1 (−10.8 to 8.8) (−0.0 [−0.6 to 0.49])−14.4 (−27.2 to −1.5) (−0.8 [−1.5 to −0.08])0.03
 Fasting insulin, μU/mL (pmol/L)*−3.1 (−4.8 to −1.2) (−18.6 [−28.8 to −7.2])0.3 (−2.2 to 1.8) (1.8 [−13.2 to 10.8])−2.8 (−4.9 to −0.2) (−16.8 [−29.4 to −1.2])0.03
 HOMA-IR*−1 (−1.4 to −0.5)0.3 (−0.8 to 0.3)−0.7 (−1.3 to −0.0)0.06
 HbA1c, % (mmol/mol)−0.1 (−0.1 to 0.0) (−1.1 [−1.1 to 0.0])0.0 (−0.1 to 0.1) (0.0 [−1.1 to 1.1])0.0 (−0.1 to 0.1) (0.0 [−1.1 to 1.1])0.30
 ALT, units/L−5.2 (−9.7 to −0.7)−3.9 (−8.5 to −0.7)−1.3 (−6.0 to 3.4)0.59
Lipids
 Total cholesterol, mg/dL (mmol/L)−6.3 (−12.4 to −0.1) (−0.16 [−0.31 to −0.0])−2.4 (−8.6 to 3.8) (−0.06 [−0.22 to 0.1])−3.9 (−12.3 to 4.5) (−0.1 [−0.31 to 0.12])0.36
 LDL cholesterol, mg/dL (mmol/L)−3.7 (−9.5 to 2) (−0.09 [−0.24 to 0.05])−4.5 (−10.3 to 1.4) (−0.11 [−0.26 to 0.04])0.8 (−6.9 to 8.4) (0.02 [−0.18 to 0.22])0.84
 HDL cholesterol, mg/dL (mmol/L)1.8 (−0.2 to 3.8) (0.05 [−0.01 to 0.1])−1.0 (−3 to 1.0) (−0.03 [−0.08 to 0.03])2.8 (−0.0 to 5.5) (0.07 [−0.0 to 0.14])0.049
 Triglycerides, mg/dL (mmol/L)−20 (−49 to 8.9) (−0.22 [−0.55 to 0.1])29.4 (0.1 to 58.7) (0.33 [0.0 to 0.66])−49.4 (−90.6 to −8.3) (−0.55 [−1.01 to −0.09])0.02
  • Data are represented as least squares mean (after adjustment for baseline) and CI. P value represents the results of mixed-model repeated-measures analysis that included all available data and controlled for baseline values.

  • ‡Data are presented using geometric means.

  • *Analysis was adjusted for baseline BMI and body fat, which are associated with missingness at baseline (36 patients did not have insulin values).