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Prevalence of responders for hepatic fat, adiposity and liver enzyme levels in response to a lifestyle intervention in children with overweight/obesity: EFIGRO randomized controlled trial.
Medrano, M, Arenaza, L, Ramírez-Vélez, R, Ortega, FB, Ruiz, JR, Labayen, I
Pediatric diabetes. 2020;(2):215-223
Abstract
BACKGROUND/OBJECTIVE Exercise and lifestyle interventions have been shown to reduce hepatic fat (HF) and adiposity in youth. However, the interindividual response in HF after a lifestyle intervention with or without exercise in children is unknown. The aim of the present study was to compare interindividual variability for HF, adiposity, gamma-glutamyl transferase (GGT), and the aspartate aminotransferase to alanine aminotransferase ratio (AST/ALT) in children with overweight/obesity participating in a 22-week lifestyle intervention with (intensive intervention) or without exercise (control intervention). METHODS Data from 102 children (9-12 years, 55% girls) with overweight/obesity participating in the EFIGRO randomized controlled trial were analyzed. Percentage HF (magnetic resonance imaging), weight, body and fat mass index (BMI and FMI), GGT, AST/ALT, cardiorespiratory fitness (CRF, 20 meters shuttle run test) were assessed before and after the intervention by the same trained researchers. The control intervention consisted in 11 sessions of a family-based lifestyle and psycho-educational program. The intensive intervention included the control intervention plus supervised exercise (3 sessions/week). RESULTS The prevalence of responders for HF (54% vs. 34%), weight (27% vs. 11%), BMI (71% vs. 47%), FMI (90% vs. 60%), and GGT (69% vs. 39%) was higher in the intensive than in the control group (Ps < 0.05). Responders for weight (16 ± 3 vs. 6 ± 2 laps) and BMI (11 ± 2 vs. 3 ± 4 laps) improved more CRF levels than non-responders (Ps < 0.05). CONCLUSIONS The addition of exercise to a lifestyle intervention may increase the responder rates for HF, adiposity, and GGT in children with overweight/obesity. Improvements in CRF may explain differences between weight and BMI responders and non-responders. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02258126.
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Comparative efficacy of interventions on nonalcoholic fatty liver disease (NAFLD): A PRISMA-compliant systematic review and network meta-analysis.
Sawangjit, R, Chongmelaxme, B, Phisalprapa, P, Saokaew, S, Thakkinstian, A, Kowdley, KV, Chaiyakunapruk, N
Medicine. 2016;(32):e4529
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Abstract
BACKGROUND The prevalence of nonalcoholic fatty liver disease (NAFLD) has significantly increased over the last decades. Despite existence of several interventions, there remains unclear which interventions work the best. METHODS A systematic review and network meta-analysis of randomized trials comparing efficacy of all treatment options in NAFLD were performed to determine comparative efficacy and safety of interventions in the management of NAFLD. Several electronic databases were searched up to Nov 15, 2015. Outcomes include liver histological outcomes (i.e., fibrosis), all-cause mortality, cirrhosis, and safety. A network meta-analysis was applied to estimate pooled risk ratios (RR). Quality of evidence was assessed using GRADE criteria. RESULTS A total of 44 studies (n = 3802) were eligible. When compared with placebo, obeticholic acid (OCA) was the only intervention that significantly improved fibrosis with RR (95% CI) of 1.91 (1.15, 3.16), while pentoxyfylline (PTX) demonstrated improved fibrosis without statistical significance with RR (95% CI) of 2.27 (0.81, 6.36). Only thiazolidinedione (TZD) and vitamin E use resulted in significant increase in resolution of NASH, while OCA, TZD, and vitamin E significantly improved other outcomes including NAS, steatosis, ballooning, and inflammation outcomes. Quality of evidence varied from very low (i.e., metformin, PTX on mean change of ballooning grade) to high (OCA, TZD, vitamin E on improving histological outcomes). Limitations of this study were lack of relevant long-term outcomes (e.g., cirrhosis, death, safety), possible small study effect, and few head-to-head studies. CONCLUSIONS Our study suggests potential efficacy of OCA, TZD, and vitamin E in improving histologic endpoints in NAFLD. These findings are however based on a small number of studies. Additional studies are awaited to strengthen this network meta-analysis.
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NASH resolution is associated with improvements in HDL and triglyceride levels but not improvement in LDL or non-HDL-C levels.
Corey, KE, Vuppalanchi, R, Wilson, LA, Cummings, OW, Chalasani, N, ,
Alimentary pharmacology & therapeutics. 2015;(3):301-9
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BACKGROUND Nonalcoholic steatohepatitis (NASH) is associated with dyslipidemia and cardiovascular disease (CVD). AIM: To determine the relationship between resolution of NASH and dyslipidemia. METHODS Individuals in the Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis (PIVENS) trial with paired liver biopsies and fasting lipid levels were included (N = 222). In the PIVENS trial individuals were randomised to pioglitazone 30 mg, vitamin E 800 IU or placebo for 96 weeks. Change in lipid levels at 96 weeks was compared between those with and without NASH resolution. RESULTS Dyslipidemia at baseline was frequent, with low high-density lipoprotein (HDL) (<40 mg/dL in men or <50 mg/dL in women) in 63%, hypertriglyceridaemia (≥150 mg/dL) in 46%, hypercholesterolaemia (≥200 mg/dL) in 47% and triglycerides (TG)/HDL >5.0 in 25%. Low-density lipoprotein (LD) ≥160 mg/dL was found in 16% and elevated non-HDL cholesterol (non-HDL-C) (≥130 mg/dL) in 73%. HDL increased with NASH resolution but decreased in those without resolution (2.9 mg/dL vs. -2.5 mg/dL, P < 0.001). NASH resolution was associated with significant decreases in TG and TG/HDL ratio compared to those without resolution (TG: -21.1 vs. -2.3 mg/dL, P = 0.03 and TG/HDL: -0.7 vs. 0.1, P = 0.003). Non-HDL-C, LDL and cholesterol decreased over 96 weeks in both groups, but there was no significant difference between groups. Treatment group did not impact lipids. CONCLUSIONS NASH resolution is associated with improvements in TG and HDL but not in other cardiovascular disease risk factors including LDL and non-HDL-C levels. Individuals with resolution of NASH may still be at increased risk of cardiovascular disease. ClinicalTrials.gov identifier: NCT00063622.
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Comparative effectiveness of pharmacological interventions for nonalcoholic steatohepatitis: A systematic review and network meta-analysis.
Singh, S, Khera, R, Allen, AM, Murad, MH, Loomba, R
Hepatology (Baltimore, Md.). 2015;(5):1417-32
Abstract
UNLABELLED We performed a Bayesian network meta-analysis combining direct and indirect treatment comparisons to assess the comparative effectiveness of pharmacological agents for the treatment of nonalcoholic steatohepatitis (NASH). Through systematic literature review, we identified nine randomized, controlled trials (RCTs) including 964 patients with biopsy-proven NASH, comparing vitamin E, thiazolidinediones (TZDs), pentoxifylline, or obeticholic acid to one another or placebo. The primary outcome was improvement in fibrosis stage; secondary outcomes were improvement in ballooning degeneration, lobular inflammation, and steatosis. We reported relative risks (RRs) and 95% confidence intervals (CIs) from direct meta-analysis and 95% credible intervals (CrIs) from Bayesian network meta-analysis, and used Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria to appraise quality of evidence. Moderate-quality evidence supports the use of pentoxifylline (RR, 0.26; 95% CrI: 0.05-1.00) and obeticholic acid (RR, 0.81; 95% CI: 0.70-0.95) over placebo in improving fibrosis. High-quality evidence supports the effect of vitamin E, TZDs, and obeticholic acid over placebo in improving ballooning degeneration. All four interventions seemed to have at least moderate-quality evidence over placebo to improve steatosis. Moderate-quality evidence supports that TZDs, pentoxifylline, and obeticholic acid decrease lobular inflammation. All the head-to-head comparisons were supported by very-low-quality evidence except for superiority of TZDs over vitamin E on improving steatosis and lobular inflammation, which had moderate-quality evidence. CONCLUSIONS Based on direct and network meta-analysis, pentoxifylline and obeticholic acid improve fibrosis, and vitamin E, TZDs, and obeticholic acid improve ballooning degeneration in patients with NASH. Future comparative trials of combination therapies targeting distinct histological features are warranted.