scholarly journals Effect of DPP-IV Inhibitors on Glycemic Variability in Patients with T2DM: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Subin Lee ◽  
Heeyoung Lee ◽  
Yoonhye Kim ◽  
EunYoung Kim
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Meta Analysis ◽  
Glycemic Variability ◽  
Mean Difference ◽  
Systematic Evaluation ◽  
Cochrane Library ◽  
Significant Heterogeneity ◽  
Dpp Iv

Abstract Glycemic variability (GV) has been an emerging target for preventing complications related to type 2 diabetes. For reducing GV, DPP-IV inhibitors have shown effectiveness compared to other oral anti-hyperglycemic drugs (OADs), but systematic evaluation has yet to be existed. A systematic review and meta-analysis of randomized controlled trials (RCTs) were performed to evaluate the effect of DPP-IV inhibitors compared with other OADs, on GV as measured by mean amplitude of glycemic excursions (MAGE). Searches were conducted using Pubmed, EMBASE, and the Cochrane Library, from which eligible studies were retrieved; seven RCTs were included in the analysis. DPP-IV inhibitors were found to significantly reduce MAGE compared to other OADs (mean difference = −14.61; 95% CI = −19.00 to −10.21; p < 0.0001) without significant heterogeneity among sulfonylureas (mean difference = −14.93; 95% CI = −21.60 to −8.26; p < 0.0001). Initial combination therapy with DPP-IV inhibitors more effectively reduced MAGE than stepwise add-on therapies (p = 0.006), although no differences in MAGE were found based on HbA1c values. These findings indicate that DPP-IV inhibitors are promising alternatives for reducing GV in type 2 diabetes patients. However, further studies utilizing larger numbers of patients and longer-term follow-ups are needed.

scholarly journals Impact of Common Spices on Glycemia in Individuals with Type 2 Diabetes: Systematic Review and Meta-Analysis of Clinical Trials

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 2-2
Author(s):  
Sepideh Alasvand ◽  
William Bridges ◽  
Vivian Haley-Zitlin
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Blood Glucose ◽  
Meta Analysis ◽  
Cochrane Library ◽  
P Value ◽  
Significant Heterogeneity ◽  
P Values ◽  
Common Spices

Abstract Objectives This study examined the effect of common spices cardamom, ginger, cumin, curcuminoids and cinnamon on improving glucose levels in individuals with type 2 diabetes by systematic review and meta-analysis. Methods PubMed, FSTA, Web of Science, CINAHEL, MEDLINE and Cochrane Library database of systematic review databases were searched using keywords (fasting blood glucose OR hemoglobin A1c OR HbA1c OR homeostasis) AND (Ginger or zingiber or “zingiber officinale” or “cinnamomum zeylanicum” or “cinnamomum aromaticum” or “cinnamomum cassia” or “cinnamomum verum” or curcumin or turmeric or curcuminoids or “curcuma longa” or langas or “curcuma zedoarias” or turmeric) AND (diabetes* OR “diabetes mellitus” OR “type 2” OR “blood glucose” OR insulin* OR antidiabet* OR “glucose level”) up to January 2020. Statistical calculations used SAS software version 9.2 (SAS, Cary NC, USA). P-values &lt; 0.05 were considered significant, P-values &lt; 0.10 were considered weakly significant. Results Twenty-three studies with 2237 trial participants were selected out of a 512 study pool. Spices decreased FBG and HbA1c %. The estimated reduction in intervention change vs. control change is as follows: A1c was −0.264 mg/dl, 95% CI (−0.5503, −0.02), P value 0.069; FBG was −9.9370 mg/dl, 95% CI (−20.79, 0.91), P value 0.07. A significant heterogeneity was observed overall among the all studies, indicating that not all studies had similar levels of decrease. Conclusions A correlation between consumption of certain common spices and significant reduction in glycemic indices among diabetes patients was proved. Funding Sources Clemson University.

scholarly journals Impact of COVID-19 lockdown on glycemic control in patients with type 1 and type 2 diabetes mellitus: a systematic review

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Claudia Eberle ◽  
Stefanie Stichling
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Meta Analysis ◽  
Mean Difference ◽  
Cochrane Library ◽  
Short Term ◽  
The Impact

Abstract Background In 2019, a new virus known as severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) has emerged. Coronavirus disease 2019 (COVID-19) was classified as a pandemic in a short period of time. In order to reduce the spread of COVID-19, many countries have imposed a lockdown with movement restrictions, social distancing and home confinement, which has affected routine healthcare activities and everyday life. The aim of this systematic review was to examine the impact of the COVID-19 lockdown on glycemic control in patients with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods We systematically identified studies by searching the databases Cochrane Library, MEDLINE via PubMed, Web of Science Core Collection, EMBASE, and CINAHL until April 2021. We included n = 33 observational studies of which n = 25 investigated T1D and n = 8 T2D. Results Overall, we analyzed n = 2881 T1D patients and n = 1823 T2D patients. Glycemic values in patients with T1D improved significantly during lockdown. Overall, n = 18 (72%) T1D studies indicated significant improvements in glycemic outcomes. Meta-analysis revealed a mean difference in HbA1c of − 0.05% (95% CI − 0.31 to 0.21) due to lockdown, and in time in range (TIR) of + 3.75% (95% CI 2.56 to 4.92). Lockdown determined a short-term worsening in glycemic values in patients with T2D. Overall, n = 4 (50%) publications observed deteriorations in glycemic control. Meta-analysis demonstrated a mean difference in HbA1c of + 0.14 (95% CI − 0.13 to 0.40) through the lockdown. Moreover, n = 3 (75%) studies reported a not significant deterioration in body weight. Conclusions Glycemic values in people with T1D significantly improved during COVID-19 lockdown, which may be associated with positive changes in self-care and digital diabetes management. In contrast, lockdown rather determined a short-term worsening in glycemic parameters in patients with T2D. Further research is required, particularly into the causes and effective T2D management during lockdown.

scholarly journals Prevalence of Type 2 Diabetes in South Africa: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 18 (11) ◽  
pp. 5868
Author(s):  
Carmen Pheiffer ◽  
Victoria Pillay-van Wyk ◽  
Eunice Turawa ◽  
Naomi Levitt ◽  
Andre P. Kengne ◽  
...  
Keyword(s):  
South Africa ◽  
Systematic Review ◽  
Type 2 Diabetes ◽  
Health Planning ◽  
Meta Analysis ◽  
Population Group ◽  
Significant Heterogeneity ◽  
Newly Diagnosed ◽  
Prevalence Data

Synthesis of existing prevalence data using rigorous systematic review methods is considered an effective strategy to generate representative and robust prevalence figures to inform health planning and policy. The purpose of this systematic review was to identify, collate, and synthesise all studies reporting the prevalence of total and newly diagnosed type 2 diabetes (T2DM), impaired glucose tolerance (IGT), and impaired fasting glucose (IFG) in South Africa. Four databases, PubMed, Scopus, Web of Science, and African Index Medicus were searched for articles published between January 1997 and June 2020. A total of 1886 articles were identified, of which 11 were included in the meta-analysis. The pooled prevalence in individuals 25 years and older was 15.25% (11.07–19.95%) for T2DM, 9.59% (5.82–14.17%) for IGT, 3.55% (0.38–9.61%) for IFG, and 8.29% (4.97–12.34%) for newly diagnosed T2DM. Although our pooled estimate may be imprecise due to significant heterogeneity across studies with regard to population group, age, gender, setting, diagnostic test, and study design, we provide evidence that the burden of glucose intolerance in South Africa is high. These factors contribute to the paucity of representative T2DM prevalence data. There is a need for well-designed epidemiological studies that use best-practice and standardised methods to assess prevalence.

scholarly journals Efficacy of Various Antidiabetic Agents as Add-On Treatments to Metformin in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Nalinee Poolsup ◽  
Naeti Suksomboon ◽  
Wanwaree Setwiwattanakul
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Combination Therapy ◽  
Meta Analysis ◽  
Mean Difference ◽  
Antidiabetic Agents ◽  
Fasting Plasma ◽  
Dpp Iv

Background and Aim. Diabetes mellitus is a chronic disease that has a great impact on patients and society. Metformin monotherapy is capable of maintaining a target glycemic control only for a short term. The aim of this study was to determine the efficacy of combination therapy of metformin with any antidiabetic agents in type 2 diabetes mellitus (T2DM) patients. Methods. Reports of randomized controlled trials (RCTs) of combination therapy of metformin with various antidiabetic agents in T2DM failing metformin alone were identified. Results. Eight studies were identified in our paper. Thiazolidinediones (TZDs) were as effective as dipeptidyl peptidase IV inhibitors (DPP IV inhs) in reducing HbA1c value (pooled mean difference −0.03%; 95% CI −0.16 to 0.10%). In comparison between TZDs and sulphonylureas (SUs), TZDs reduced fasting plasma insulin (FPI) more effectively than SUs (pool mean difference −5.72 μU/mL; 95% CI −8.21 to −3.22 μU/mL, ), but no significant differences were detected in the effects on HbA1c and fasting plasma glucose (FPG) (pooled mean difference −2.19 mg/dL; 95% CI −11.32 to 6.94 mg/dL, ). Conclusions. Our study showed that TZDs reduced FPG better than did DPP IV inhs and decreased FPI more than did SUs.

scholarly journals Metabolomics Signatures in Type 2 Diabetes: A Systematic Review and Integrative Analysis

2019 ◽  
Vol 105 (4) ◽  
pp. 1000-1008 ◽  
Author(s):  
Yue Sun ◽  
Hao-Yu Gao ◽  
Zhi-Yuan Fan ◽  
Yan He ◽  
Yu-Xiang Yan
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Metabolic Pathways ◽  
Meta Analysis ◽  
Random Effect ◽  
Bioinformatic Analysis ◽  
Cochrane Library ◽  
Isoleucine Leucine ◽  
Increased Risk

Abstract Objective Metabolic signatures have emerged as valuable signaling molecules in the biochemical process of type 2 diabetes (T2D). To summarize and identify metabolic biomarkers in T2D, we performed a systematic review and meta-analysis of the associations between metabolites and T2D using high-throughput metabolomics techniques. Methods We searched relevant studies from MEDLINE (PubMed), Embase, Web of Science, and Cochrane Library as well as Chinese databases (Wanfang, Vip, and CNKI) inception through 31 December 2018. Meta-analysis was conducted using STATA 14.0 under random effect. Besides, bioinformatic analysis was performed to explore molecule mechanism by MetaboAnalyst and R 3.5.2. Results Finally, 46 articles were included in this review on metabolites involved amino acids, acylcarnitines, lipids, carbohydrates, organic acids, and others. Results of meta-analysis in prospective studies indicated that isoleucine, leucine, valine, tyrosine, phenylalanine, glutamate, alanine, valerylcarnitine (C5), palmitoylcarnitine (C16), palmitic acid, and linoleic acid were associated with higher T2D risk. Conversely, serine, glutamine, and lysophosphatidylcholine C18:2 decreased risk of T2D. Arginine and glycine increased risk of T2D in the Western countries subgroup, and betaine was negatively correlated with T2D in nested case-control subgroup. In addition, slight improvements in T2D prediction beyond traditional risk factors were observed when adding these metabolites in predictive analysis. Pathway analysis identified 17 metabolic pathways may alter in the process of T2D and metabolite-related genes were also enriched in functions and pathways associated with T2D. Conclusions Several metabolites and metabolic pathways associated with T2D have been identified, which provide valuable biomarkers and novel targets for prevention and drug therapy.

scholarly journals Protocol for systematic review and meta-analysis of sex hormones and diabetes risk in ageing men and women of African ancestry

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024446 ◽  
Author(s):  
Nyuyki Clement Kufe ◽  
Maphoko Masemola ◽  
Tinashe Chikowore ◽  
Andre Pascal Kengne ◽  
Tommy Olsson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Sex Hormones ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Diabetes Risk ◽  
Cochrane Library ◽  
Men And Women ◽  
Inconsistency Index

AimTo present the protocol of a systematic review and meta-analysis of the available evidence examining the association between sex hormones and type 2 diabetes risk in ageing men and women of African descent.MethodsWe shall conduct a comprehensive search of published studies that examined the association between sex hormones and type 2 diabetes risk in men and women aged ≥40 years from 01/01/1980 to 31/03/2018 with no language restriction. Databases to be searched include: PubMed, Scopus, Cochrane Library, Cumulative Index to Nursing and Allied Health, ISI Web of Science, Clinical Trial registries, Google Scholar and institutional websites such as the WHO, American Diabetes Association, International Diabetes Federation, World Diabetes Foundation, European Association for the Study of Diabetes, African Journal Online and ProQuest databases. This protocol is developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. Independent screening for eligible studies using defined criteria and data extraction, will be completed in duplicate. Discrepancies will be resolved by consensus or consultation with a third researcher. Risk of bias of included studies will be assessed by the appropriate Cochrane risk of bias tool. The overall association estimates will be pooled using appropriate meta-analytic techniques. Heterogeneity will be assessed using Cochrane Q statistic and the inconsistency index (I2). The random effects model will be used to calculate a pooled estimate.Ethics and disseminationNo ethics clearance is required as no primary data will be collected. The systematic review and meta-analysis are part of a PhD project at WITS University (Johannesburg, South Africa) and results will be presented at conferences and published in a peer-review journal. The results will guide future population specific interventions.PROSPERO registration numberCRD42017074581.

The Effectiveness of Telemedicine Solutions for the Management of Type 2 Diabetes: A Systematic Review, Meta-Analysis, and Meta-Regression

2021 ◽  
pp. 193229682110646
Author(s):  
Stine Hangaard ◽  
Sisse H. Laursen ◽  
Jonas D. Andersen ◽  
Thomas Kronborg ◽  
Peter Vestergaard ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Systematic Reviews ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Sufficient Information ◽  
Meta Regression ◽  
Meta Analyses

Background: Previous systematic reviews have aimed to clarify the effect of telemedicine on diabetes. However, such reviews often have a narrow focus, which calls for a more comprehensive systematic review within the field. Hence, the objective of the present systematic review, meta-analysis, and meta-regression is to evaluate the effectiveness of telemedicine solutions versus any comparator without the use of telemedicine on diabetes-related outcomes among adult patients with type 2 diabetes (T2D). Methods: This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We considered telemedicine randomized controlled trials (RCT) including adults (≥18 years) diagnosed with T2D. Change in glycated hemoglobin (HbA1c, %) was the primary outcome. PubMed, EMBASE, and the Cochrane Library Central Register of Controlled Trials (CENTRAL) were searched on October 14, 2020. An overall treatment effect was estimated using a meta-analysis performed on the pool of included studies based on the mean difference (MD). The revised Cochrane risk-of-bias tool was applied and the certainty of evidence was graded using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Results: The final sample of papers included a total of 246, of which 168 had sufficient information to calculate the effect of HbA1c%. The results favored telemedicine, with an MD of −0.415% (95% confidence interval [CI] = −0.482% to −0.348%). The heterogeneity was great (I2 = 93.05%). A monitoring component gave rise to the higher effects of telemedicine. Conclusions: In conclusion, telemedicine may serve as a valuable supplement to usual care for patients with T2D. The inclusion of a telemonitoring component seems to increase the effect of telemedicine.

Effects of Urtica dioica on Metabolic Profiles in Type 2 Diabetes: A Systematic Review and Meta-Analysis of Clinical Trials

2021 ◽  
Vol 21 ◽  
Author(s):  
Reza Tabrizi ◽  
Eghbal Sekhavati ◽  
Peyman Nowrouzi-Sohrabi ◽  
Shahla Rezaei ◽  
Parinaz Tabari ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Clinical Trials ◽  
Meta Analysis ◽  
Hdl Cholesterol ◽  
Urtica Dioica ◽  
Cochrane Library ◽  
Metabolic Profiles

Background: Several studies have investigated the effect of Urtica dioica (UD) consumption on metabolic profiles in patients with type 2 diabetes mellitus (T2DM); however, the findings are inconsistent. This systematic review and meta-analysis of clinical trials was performed to summarize the evidence of the effects of UD consumption on metabolic profiles in patients with T2DM. Methods: Eligible studies were retrieved from searches of PubMed, Embase, Scopus, Web of Science, Cochrane Library and Google Scholar databases until December 2019. Cochran (Q) and I-square statistics were used to examine heterogeneity across included clinical trials. Data were pooled by using fixed-effect or random-effects model and expressed as weighted mean difference (WMD) and 95% confidence interval (CI). Results: Among 1485 citations, thirteen clinical trials were found to be eligible for the current meta-analysis. UD consumption significantly decreased levels of fasting blood glucose (FBG) (WMD= -17.17 mg/dl, 95% CI: -26.60, -7.73, I2= 93.2%), hemoglobin A1c (HbA1c) (WMD= -0.93, 95% CI: -1.66, -0.17, I2= 75.0%), C-reactive protein (CRP) (WMD= -1.09 mg/dl, 95% CI: -1.64, -0.53, I2= 0.0%), triglycerides (WMD = -26.94 mg/dl, 95 % CI = [-52.07, -1.82], P = 0.03, I2 = 90.0%), systolic blood pressure (SBP) (WMD= -5.03 mmHg, 95% CI = -8.15, -1.91, I2= 0.0%) in comparison to the control groups. UD consumption did not significantly change serum levels of insulin (WMD= 1.07 μU/ml, 95% CI: -1.59, 3.73, I2= 63.5%), total-cholesterol (WMD= -6.39 mg/dl, 95% CI: -13.84, 1.05, I2= 0.0%), LDL-cholesterol (LDL-C) (WMD= -1.30 mg/dl, 95% CI: -9.95, 7.35, I2= 66.1%), HDL-cholesterol (HDL-C) (WMD= 6.95 mg/dl, 95% CI: -0.14, 14.03, I2= 95.4%), body max index (BMI) (WMD= -0.16 kg/m2, 95% CI: -1.77, 1.44, I2= 0.0%), and diastolic blood pressure (DBP) (WMD= -1.35 mmHg, 95% CI: -2.86, 0.17, I2= 0.0%) among patients with T2DM. Conclusion: UD consumption may result in an improvement in levels of FBS, HbA1c, CRP, triglycerides and SBP, but did not affect on levels of insulin, total-, LDL-, and HDL-cholesterol, BMI, and DBP in patients with T2DM.

scholarly journals Anti-diabetic agents for prevention of type 2 diabetes mellitus in people with pre-diabetes: a systematic review and network meta-analysis protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e029073 ◽  
Author(s):  
Xianzhe Wang ◽  
Jiabin Liu ◽  
Lijin Huang ◽  
Hai Zeng ◽  
Guoxin He ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Systematic Review ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Diabetes Prevention ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Glucose Lowering ◽  
Increased Risk

IntroductionType 2 diabetes mellitus (T2DM) is a substantial health problem worldwide. Pre-diabetic state is associated with increased risk for the development of diabetes. There are various pharmacological therapies with glucose-lowering activity for diabetes prevention. Of those, most are being compared with placebo instead of active agents. The relative effects and safety of different glucose-lowering drugs still remain uncertain. To address this gap, we will conduct a systematic review and network meta-analysis (NMA) to evaluate comparative efficacy and safety of glucose-lowering agents for T2DM prevention in patients with pre-diabetes.Methods and analysisPubMed, the Cochrane library and Embase will be searched from inception to December 2019 for relevant randomised controlled trials (RCTs) that examined anti-diabetic drugs for diabetes prevention in patients with pre-diabetes. Two reviewers working independently will screen titles, abstracts and full papers. Data extraction will also be completed by two independent authors. The primary outcome will be the incidence of T2DM in patients with pre-diabetes at baseline. Secondary outcomes will include the achievement of normoglycaemia, all-cause mortality, cardiovascular mortality and hypoglycaemic event. Pairwise meta-analysis and NMA will be conducted for each outcome using a frequentist random-effects model. Additionally, subgroup analyses will also be performed. The comparison-adjusted funnel plot will be used to assess publication bias. The overall quality of evidence will be rated with the Grading of Recommendations Assessment, Development and Evaluation framework. Data analysis will be conducted using Stata V.14.0.Ethics and disseminationEthics approval is not required. We plan to submit the results of this study to a peer-review journal.PROSPERO registration numberCRD42019119157.

scholarly journals The Effects of Exercise Interventions on Balance Capacity in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 58 ◽  
pp. 004695802110182
Author(s):  
Jiawei Qin ◽  
Kaize Zhao ◽  
Yannan Chen ◽  
Shuai Guo ◽  
Yue You ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Systematic Review ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Exercise Intervention ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Control Group ◽  
Significant Difference

The effect of exercise intervention on balance capacity among type 2 diabetes mellitus (T2DM) patients has not been evaluated. The objective of this systematic review and meta-analysis is to investigate the effect of exercise intervention on balance capacity among T2DM patients compared to the control group (usual care, waitlist, no-treatment, education). We conducted a comprehensive literature search through PubMed, EMBASE, Physiotherapy Evidence Database (PEDro), Cochrane library, Web of Science (WOS) from inception to August 2020. The literature language was limited to English. Randomized controlled trials (RCTs) or quasi-experimental (Q-E) trials that examined the effect of exercise intervention on balance capacity among T2DM patients were included. We used the standard methods of meta-analysis to evaluate the outcomes of exercise intervention for balance capacity of T2DM patients. A total of 14 trials (11 RCTs and 3 Q-E trials) involving 883 participants were eligible. The meta-analysis of some studies demonstrated that exercise intervention could significantly improve Berg Balance Scale (BBS) (MD = 2.56; 95%CI [0.35, 4.77]; P = .02), SLST (Single Leg Stance Test) under the eyes-open (EO) condition (MD = 3.63; 95%CI [1.79, 5.47]; P = .0001) and eyes-close (EC) condition (MD = 0.41; 95%CI [0.10, 0.72]; P = .01) compared to control group. There was no significant difference in Time Up and Go Test (TUGT) (MD = −0.75; 95%CI [−1.69, 0.19]; P = .12) and fall efficacy (SMD = −0.44; 95%CI [−0.86, −0.01]; P = .05). Narrative review of some studies indicated that exercise intervention could improve postural stability measured by Sensory Organization Test (SOT) and Center of Pressure (COP) variables, etc. This systematic review and meta-analysis summarized that exercise intervention could improve balance capacity in T2DM patients. However, further studies with high quality are required to evaluate its effect.

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