Systemic inflammation and oxidative burden in patients with type 2 diabetes mellitus (T2DM) causes deleterious cardiovascular outcomes. We sought to investigate the clinical antioxidative and anti-inflammatory effects of empagliflozin. Platelet function, oxidant and antioxidant biomarkers and pro-inflammatory agents at baseline and at 26 weeks were measured. A total of 95 patients (41.05% male, mean age 62.85 ± 7.91 years, mean HbA1c 7.89 ± 0.96%) with concomitant T2DM and coronary artery disease (CAD) were randomized (1:1) to receive empagliflozin (10 mg/daily) or placebo. Patients treated with empagliflozin had lower levels of interleukin 6 (IL-6) (adjusted difference (adiff): − 1.06 pg/mL, 95% CI − 1.80; − 0.32, P = 0.006), interleukin 1β (IL-1β) and high-sensitive C-reactive protein (Hs-CRP) (adiff: − 4.58 pg/mL and − 2.86 mg/L; P = 0.32 and 0.003, respectively) compared to placebo. There were elevations in super oxidase dismutase (SOD) activity, glutathione (GSHr), and total antioxidant capacity (TAC) with empagliflozin (adiff: 3.7 U/mL, 0.57 muM, and 124.08 mmol/L, 95% CI 1.36; 6.05, 0.19; 0.95, and 47.98; 200.18, P = 0.002, 0.004, and 0.002, respectively). While reactive oxygen species (ROS) improved significantly (adiff: − 342.51, 95% CI − 474.23; − 210.79, P < 0.001), the changes in catalase activity (CAT), malondialdehyde (MDA), or protein carbonyl groups (PCG) were not significant. Moreover, the P-selectin antigen expression on platelet surface was significantly reduced (adiff: − 8.81, 95% CI − 14.87; − 2.75, P = 0.005). Markers of glycemic status (fasting blood glucose, HbA1c, and HOMA-IR (homeostatic model assessment for insulin resistance) significantly improved (P < 0.001). Among patients with T2DM and CAD, 6-month treatment with empagliflozin can mitigate inflammation, platelet activity and oxidative stress and is associated with clinical cardiovascular benefits.Trial Registration Iranian Registry of Clinical Trials. www.IRCT.ir, Identifier: IRCT20190412043247N2. Registration Date: 6/13/2020. Registration timing: prospective
Background: Emerging evidence indicates that metformin has anti-inflammatory effect; however, the results differ concerning randomized controlled trails of the effect of metformin on inflammatory markers in type 2 diabetes (T2D) patients. Objective: This study reassessed the data on the effect of metformin treatment on inflammatory markers in T2D patients through a systematic review and meta-analysis. Methods: A systematic search was performed in the PubMed, ISI Web of Science, EMBASE, Cochrane Library and Scopus databases to collect relevant published data up to September 2020. Data of each study was combined using random-effects model. Subgroup analysis was performed based on subgroups of the treatment duration, dose and target population. Results: Thirteen RCTs including 1776 participants with T2D were analyzed. Although CRP levels significantly decreased [SMD: –0.76 mg/L; 95% CI (–1.48, –0.049); P = 0.036] in patients with T2D following metformin treatment, circulating levels of TNF-α [SMD: –0.17 pg/mL; 95% CI (–0.55, 0.20); P = 0.37] and IL-6 [SMD: –0.06 pg/mL; 95% CI (–0.38, 0.25); P = 0.69] were insignificant after metformin treatment. Compared to treatment duration of less than 24 weeks, longer treatment duration (more than 24 weeks) was associated with reduced level of CRP. Relevance to Patient Care and Clinical Practice: Based on available evidence from RCTs in this meta-analysis, metformin decreased CRP level. However, strategies for the treatment of inflammation should focus on metformin in patients with T2D. Conclusion: The present study evidences that therapy with metformin can reduces CRP level significantly in T2D patients compared to other inflammatory markers.
Decreased adiponectin levels has been demonstrated in postmenopausal (PMP) women. Soy isoflavones, as an herbal product have been shown to increase adiponectin level but the results are inconclusive and inconsistent. The present study reassessed the data on the impact of soy isoflavones supplementation on adiponectin levels in PMP women through a meta-analysis. A systematic search was performed in the databases of PubMed, Web of science, Scopus and the Cochrane library. The literature search identified 830 studies with duplicates. Out of those, 80 were screened for title and abstract and 12 articles were ultimately selected for the analysis. Meta-regression and subgroup analyses, based on the moderator variables such as treatment duration, dose of soy isoflavones and BMI were performed. The quality of the studies was evaluated using the Grading of Recommendation Assessment, Development and Evaluation (GRADE) approach. The results revealed that soy isoflavones supplementation significantly increased the circulating level of adiponectin in PMP women (SMD: 0.36 µg/mL; 95% CI (0.05 to 0.66); P= 0.02). No publication bias was observed using Begg's (P = 0.38) and Egger's (P = 0.07) tests. Sensitivity analysis indicated the results were completely powerful and stable. Moreover, Meta-regression and subgroup analyses indicated a significant increase of adiponectin levels in subgroups of dose > 50 mg and treatment duration less or equal 3 months. Our findings showed significantly increase in adiponectin levels after isoflavones-supplemented soy consumption in postmenopausal women, who received dose > 50 mg of soy isoflavones in treatment duration ≤ 3 months.
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