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Table 2 Summary of NAFLD/NASH clinical trials incorporating stable-label isotope DNL assessments

From: Clinical assessment of hepatic de novo lipogenesis in non-alcoholic fatty liver disease

Subjects Study Type Intervention Period Tracer Outcome Ref
Healthy controls (n = NR) Randomized double-blind, placebo-controlled crossover Compound 9 (600 mg) or placebo with one week washout Single dose [1-13C]-acetate (9–9.5 mg/min) for 20.5 h Compound 9 reduced fructose-induced fractional DNL [47]
Type 2 diabetes (n = 12) Open label, randomized (1:1) Pioglitazone (dose escalated to 45 mg/day)
Rosiglitazone (dose escalated to 4 mg twice daily)
20 weeks [1-13C]-acetate (10 mg/min) For 12 h Pioglitazone reduced fasting fractional DNL over course of acetate infusion
No change with Rosiglitazone
[74]
Type 2 diabetes (n = 60) Randomized double-blind placebo-controlled (1:1) Colesevelam (3.75 g/day) or placebo 12 weeks [1-13C]-acetate (10 mg/min)
19.5 h continuous infusion
Placebo increased fasting and postprandial fractional DNL, no change with colesevelam [81]
Biopsy-proven NASH (n = 14) Randomized double-blind, placebo-controlled (1;1) Liraglutide (dose escalated to 1.8 mg/day) or placebo 12 weeks 2H2O (3 g/kg total body water in 2 doses) plus ad libitum drinking water enriched with 0.4 % 2H2O over 20 h Liraglutide decreased fasting % change DNL [29]
  1. NR Not reported