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. Author manuscript; available in PMC: 2022 Mar 14.
Published in final edited form as: Med. 2021 May 12;2(7):814–835. doi: 10.1016/j.medj.2021.04.001

Table 2.

Comparison of study parameters at baseline and 12 months after metreleptin treatment in the PL study

Parameters n* Baseline Month 12 P value
Body weight (kg) 19 75.6 ± 21.8 75.0 ± 23.1 0.494
Body mass index (kg/m2) 19 26.8 ± 5.8 26.5 ± 6.3 0.270
Waist-to-hip ratio 19 1.00 ± 0.08 0.98 ± 0.08 0.079
FMR (%fat trunk/ %fat legs) 19 1.8 ± 0.5 1.7 ± 0.7 0.537
Systolic blood pressure (mmHg) 19 126 ± 16 128 ± 17 0.583
Diastolic blood pressure (mmHg) 19 74 ± 11 73 ± 12 0.653
Hemoglobin A1c (%) 19 8.9 ± 1.9 8.2 ± 1.9 0.077
Glucose (mg/dL) 19 193 ± 84 164 ± 67 0.055
# Triglyceride (mg/dL) 19 576 (327 – 1016) 301 (206 – 441) 0.014
# AST (IU/L) 19 42 ± 29 30 ± 14 0.043
# ALT (IU/L) 19 51 ± 33 36 ± 23 0.004
REE (kcal) 19 1851 ± 333 1719 ± 369 0.004
RQ 19 0.77 ± 0.07 0.75 ± 0.06 0.305
Liver fat (Dixon MR method) (%) 19 13 ± 7 8 ± 5 0.001
NAS 18 5 ± 1 4 ± 1 < 0.001
NASH score 18 6 ± 2 5 ± 2 0.008
**Total intake (grams) 18 2791 ± 1141 2668 ± 675 0.809
Total energy intake (kcal) 18 1710 ± 412 1540 ± 531 0.253
Total fat intake (grams) 18 73 ± 26 64 ± 24 0.175
Total carbohydrate intake (grams) 18 184 ± 49 166 ± 74 0.372
Total protein intake (grams) 18 88 ± 18 84 ± 28 0.802
*

Number of participants with data available at baseline and 12 months for each outcome. Nineteen participants completed 1 year of metreleptin treatment and 18 completed a second liver biopsy. One subject did not complete the second biopsy due to use of anticoagulation. Energy intake was assessed in 18 subjects as one subject (patient 1) did not return baseline food records. ALT: alanine aminotransferase, AST: aspartate aminotransferase, FMR: fat mass ratio, REE: resting energy expenditure, RQ: respiratory quotient. NAS: non-alcoholic fatty liver disease activity score, the sum of scores for steatosis, lobular inflammation, and ballooning, NASH score: nonalcoholic steatohepatitis score equals the sum of scores for steatosis, lobular inflammation, hepatocellular ballooning, and fibrosis.

**

Total intake includes food, water and other beverages. Levels are compared by using paired sample t-test.

#

Tests are run on log-transformed data. Data are presented as mean ± standard deviation (SD). Triglycerides are shown as geometric mean with 95% confidence intervals.