scholarly journals Long-term treatment with metformin in obese, insulin-resistant adolescents: results of a randomized double-blinded placebo-controlled trial

2016 ◽  
Vol 6 (8) ◽  
pp. e228-e228 ◽  
Author(s):  
M P van der Aa ◽  
M A J Elst ◽  
E M W van de Garde ◽  
E G A H van Mil ◽  
C A J Knibbe ◽  
...  
Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Heshen Tian ◽  
Yumin Zhou ◽  
Longhui Tang ◽  
Fan Wu ◽  
Zhishan Deng ◽  
...  

Abstract Introduction The presence of increased oxidative stress and airway inflammation has been proven in subjects with chronic obstructive pulmonary disease (COPD). Several studies have demonstrated that drugs with antioxidant and anti-inflammatory properties such as N-acetylcysteine (NAC) can reduce the rate of exacerbations in patients with COPD. However, the beneficial effects of NAC in early-stage COPD are minimally discussed. We are investigating whether high-dose NAC has therapeutic effects in Chinese patients with early-stage COPD. Method and analysis A randomized, double-blinded, placebo-controlled, parallel-group, multicenter clinical trial is evaluating the efficacy and safety of NAC for the long-term treatment of patients with early-stage COPD at 24 centers in China. Subjects aged 40–80 years and recruited by physicians or researchers with special training will be randomized to either NAC 600 mg twice daily group or matching placebo group for 2 years. Measurements will include forced expiratory volume in 1 s (FEV1), the number of COPD exacerbations, health-related quality, and pharmacoeconomic analysis. Discussion Currently, there are no randomized controlled trials with high-dose N-acetylcysteine (600 mg twice daily) for patients with mild-to-moderate COPD (GOLD I–II). We designed this multicenter randomized controlled trial (RCT) to assess the effectiveness, safety, and cost-effectiveness of long-term treatment with high-dose N-acetylcysteine. The results of this trial may guide clinical practice and change the standard of early COPD management. Trial registration Chinese Clinical Trial Registry ChiCTR-IIR-17012604. Registered on 07 September 2017.


2018 ◽  
Vol 20 (8) ◽  
pp. 1951-1956 ◽  
Author(s):  
Mattijs Out ◽  
Wiebe M. C. Top ◽  
Philippe Lehert ◽  
Casper A. Schalkwijk ◽  
Coen D. A. Stehouwer ◽  
...  

2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Glaucia S. Tres ◽  
Sandra C. Fuchs ◽  
Fabiana Piovesan ◽  
Patricia Koehler-Santos ◽  
Fernanda dos S. Pereira ◽  
...  

Introduction. Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. Methods. This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [HbA1c≤7.0% (53 mmol/mol)] and change in inflammatory mediators. Results. Participants in the diacerein group had greater reductions in mean HbA1c level in comparison to placebo (−0.98; 95% CI: −2.02 to 0.05, P=0.06), independently of confounding factors. The difference in HbA1c level was −1.3 (95% CI: −2.3 to −0.4) in favor of diacerein (P=0.007) in those with <14 years of diabetes duration versus 0.05 (−0.7 to 0.8; P=0.9) in those with longer duration. The diacerein group had a 50% increase in the number of participants at the lowest TNF-α level (≤1.46 pg/mL). Conclusions. In patients with long-established T2DM under long-term treatment with glucose-lowering agents, diacerein improves metabolic control as measured by HbA1c level and has a favorable impact on inflammatory profile. Clinical Trial Registry. This trial is registered with Brazilian Clinical Trials Registry (ReBEC) number RBR-29j956.


2015 ◽  
Vol 27 (6) ◽  
pp. 805-815 ◽  
Author(s):  
H. Piessevaux ◽  
E. Corazziari ◽  
E. Rey ◽  
M. Simren ◽  
A. Wiechowska‐Kozlowska ◽  
...  

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