scholarly journals Anti-Diabetic and Antiresorptive Pharmacotherapies for Prevention and Treatment of Type 2 Diabetes-Induced Bone Disease: Protocol for a Two-Part Systematic Review and Network Meta-Analysis

2019 ◽  
Author(s):  
Jiawen Deng ◽  
Umaima Abbas ◽  
Oswin Chang ◽  
Sayan Dhivagaran ◽  
Stephanie Sanger ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
At Risk ◽  
Bone Disease ◽  
Bone Health ◽  
Risk Of Bias ◽  
Randomized Controlled ◽  
Meta Analyses

ABSTRACTIntroductionPatients with type 2 diabetes mellitus (T2DM) are at risk for a variety of severe debilitating effects. One of the most serious complications experienced by T2DM patients are skeletal diseases caused by changes in the bone microenvironment. As a result, T2DM patients are at risk for higher prevalence of fragility fractures.There are a variety of treatments available for counteracting this effect. Some anti-diabetic medications, such as metformin, have been shown to have a positive effect on bone health without the addition of additional drugs into patients’ treatment plans. Chinese randomized controlled trial (RCT) studies have also proposed antiresorptive pharmacotherapies as a viable alternative treatment strategy. Previous network meta-analyses (NMAs) and meta-analyses regarding this topic did not include all available RCT trials, or only performed pairwise comparisons. We present a protocol for a two-part NMA that incorporates all available RCT data to provide the most comprehensive ranking of anti-diabetics (Part I) and antiresorptive (Part II) pharmacotherapies in terms of their ability to decrease fracture incidences, increase bone mineral density (BMD), improve indications of bone turnover markers (BTMs), and decrease pain in adult T2DM patients.Methods and AnalysisWe will search MEDLINE, EMBASE, PubMed, Web of Science, CINAHL, CENTRAL and Chinese literature sources (CNKI, CQVIP, Wanfang Data, Wanfang Med Online) for randomized controlled trials (RCTs) which fit our criteria. We will include adult T2DM patients who have taken anti-diabetics (Part I) or antiresorptive (Part II) therapies with relevant outcome measures in our study.We will perform title/abstract and full-text screening as well as data extraction in duplicate. Risk of bias (RoB) will be evaluated in duplicate for each study, and the quality of evidence will be examined using CINeMA in accordance to the GRADE framework. We will use R and gemtc to perform the NMA. We will report changes in BMD, BTM and pain scores in either weighted or standardized mean difference, and we will report fracture incidences as odds ratios. We will use the surface under the cumulative ranking curve (SUCRA) scores to provide numerical estimates of the rankings of interventions.Ethics and DisseminationThe study will not require ethics approval. The findings of the two-part NMA will be disseminated in peer-reviewed journals and presented at conferences. We aim to produce the most comprehensive quantitative analysis regarding the management of T2DM bone disease. Our analysis should be able to provide physicians and patients with up-to-date recommendations for anti-diabetic medications and antiresorptive pharmacotherapies for maintaining bone health in T2DM patients.Systematic Review RegistrationInternational Prospective Register for Systematic Reviews (PROSPERO) — CRD42019139320ARTICLE SUMMARYStrengths and limitations of this studyLiterature search in Chinese databases will yield new RCT evidence regarding the efficacy of anti-diabetics in treating T2DM bone diseaseUsing network meta-analytical techniques to analyze the relative efficacy of antiresorptive therapies will allow us to include new treatment arms, such as zoledronic acid and risedronate.Only RCTs will be included and the quality of trials and networks will be evaluated using Risk of Bias, GRADE and comparison-adjusted funnel plots.Chinese clinicians may not use the same procedures and practices as Western clinicians, therefore the outcomes from Chinese RCTs may not apply to the Western healthcare systems.The study design does not allow the comparison of anti-diabetics with antiresorptive therapies or combinations of the two.

scholarly journals Antidiabetic and antiosteoporotic pharmacotherapies for prevention and treatment of type 2 diabetes-induced bone disease: protocol for two network meta-analyses

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e034741 ◽  
Author(s):  
Jiawen Deng ◽  
Umaima Abbas ◽  
Oswin Chang ◽  
Thanansayan Dhivagaran ◽  
Stephanie Sanger ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
At Risk ◽  
Bone Disease ◽  
Bone Health ◽  
Evaluation Framework ◽  
Adult Patients ◽  
Cochrane Central Register ◽  
Mineral Density ◽  
Meta Analyses

IntroductionPatients with type 2 diabetes mellitus (T2DM) are at risk for a variety of severe debilitating effects. One of the most serious complications experienced by patients with T2DM are skeletal diseases caused by changes in the bone microenvironment. As a result, patients with T2DM are at risk for higher prevalence of fragility fractures. There are a variety of treatments available for counteracting this effect. Some antidiabetic medications, such as metformin, have been shown to have a positive effect on bone health without the addition of additional drugs into patients’ treatment plans. Chinese randomised controlled trial (RCT) studies have also proposed antiosteoporotic pharmacotherapies as a viable alternative treatment strategy. Previous network meta-analyses (NMAs) and meta-analyses regarding this topic did not include all available RCT trials, or only performed pairwise comparisons. We present a protocol for a two-part NMA that incorporates all available RCT data to provide the most comprehensive ranking of antidiabetics (part I) and antiosteoporotic (part II) pharmacotherapies in terms of their ability to decrease fracture incidences, increase bone mineral density (BMD) and improve indications of bone turnover markers (BTMs) in adult patients with T2DM.Methods and analysisWe will search Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials and Chinese literature sources (China National Knowledge Infrastructure, Chongqing VIP Information, Wanfang Data, Wanfang Med Online) for RCTs, which fit our criteria. We will include adult patients with T2DM who have taken antidiabetics (part I) or antiosteoporotic (part II) therapies with relevant outcome measures in our study. We will perform title/abstract and full-text screening as well as data extraction in duplicate. Risk of bias will be evaluated in duplicate for each study, and the quality of evidence will be examined using Confidence in Network Meta-Analysis in accordance to the Grading of Recommendations Assessment, Development and Evaluation framework. We will use R and gemtc to perform the NMA. We will report changes in BMD and BTMs in either weighted or standardised mean difference, and we will report fracture incidences as ORs. We will use the Surface Under the Cumulative Ranking Curve scores to provide numerical estimates of the rankings of interventions.Ethics and disseminationThe study will not require ethics approval. The findings of the two-part NMA will be disseminated in peer-reviewed journals and presented at conferences. We aim to produce the most comprehensive quantitative analysis regarding the management of T2DM bone disease. Our analysis should be able to provide physicians and patients with up-to-date recommendations for antidiabetic medications and antiosteoporotic pharmacotherapies for maintaining bone health in patients with T2DM.PROSPERO registration numberCRD42019139320.

scholarly journals Efficacy and safety of low and very low carbohydrate diets for type 2 diabetes remission: systematic review and meta-analysis of published and unpublished randomized trial data

BMJ ◽  
2021 ◽  
pp. m4743
Author(s):  
Joshua Z Goldenberg ◽  
Andrew Day ◽  
Grant D Brinkworth ◽  
Junko Sato ◽  
Satoru Yamada ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Type 2 Diabetes ◽  
Weight Loss ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Low Carbohydrate ◽  
Remission Of Diabetes

Abstract Objective To determine the efficacy and safety of low carbohydrate diets (LCDs) and very low carbohydrate diets (VLCDs) for people with type 2 diabetes. Design Systematic review and meta-analysis. Data sources Searches of CENTRAL, Medline, Embase, CINAHL, CAB, and grey literature sources from inception to 25 August 2020. Study selection Randomized clinical trials evaluating LCDs (<130 g/day or <26% of a 2000 kcal/day diet) and VLCDs (<10% calories from carbohydrates) for at least 12 weeks in adults with type 2 diabetes were eligible. Data extraction Primary outcomes were remission of diabetes (HbA 1c <6.5% or fasting glucose <7.0 mmol/L, with or without the use of diabetes medication), weight loss, HbA 1c , fasting glucose, and adverse events. Secondary outcomes included health related quality of life and biochemical laboratory data. All articles and outcomes were independently screened, extracted, and assessed for risk of bias and GRADE certainty of evidence at six and 12 month follow-up. Risk estimates and 95% confidence intervals were calculated using random effects meta-analysis. Outcomes were assessed according to a priori determined minimal important differences to determine clinical importance, and heterogeneity was investigated on the basis of risk of bias and seven a priori subgroups. Any subgroup effects with a statistically significant test of interaction were subjected to a five point credibility checklist. Results Searches identified 14 759 citations yielding 23 trials (1357 participants), and 40.6% of outcomes were judged to be at low risk of bias. At six months, compared with control diets, LCDs achieved higher rates of diabetes remission (defined as HbA 1c <6.5%) (76/133 (57%) v 41/131 (31%); risk difference 0.32, 95% confidence interval 0.17 to 0.47; 8 studies, n=264, I 2 =58%). Conversely, smaller, non-significant effect sizes occurred when a remission definition of HbA 1c <6.5% without medication was used. Subgroup assessments determined as meeting credibility criteria indicated that remission with LCDs markedly decreased in studies that included patients using insulin. At 12 months, data on remission were sparse, ranging from a small effect to a trivial increased risk of diabetes. Large clinically important improvements were seen in weight loss, triglycerides, and insulin sensitivity at six months, which diminished at 12 months. On the basis of subgroup assessments deemed credible, VLCDs were less effective than less restrictive LCDs for weight loss at six months. However, this effect was explained by diet adherence. That is, among highly adherent patients on VLCDs, a clinically important reduction in weight was seen compared with studies with less adherent patients on VLCDs. Participants experienced no significant difference in quality of life at six months but did experience clinically important, but not statistically significant, worsening of quality of life and low density lipoprotein cholesterol at 12 months. Otherwise, no significant or clinically important between group differences were found in terms of adverse events or blood lipids at six and 12 months. Conclusions On the basis of moderate to low certainty evidence, patients adhering to an LCD for six months may experience remission of diabetes without adverse consequences. Limitations include continued debate around what constitutes remission of diabetes, as well as the efficacy, safety, and dietary satisfaction of longer term LCDs. Systematic review registration PROSPERO CRD42020161795.

scholarly journals Dietary factors and diabetes-related health outcomes in patients with type 2 diabetes: protocol for a systematic review and meta-analysis of prospective observational studies

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e027298
Author(s):  
Janett Barbaresko ◽  
Manuela Neuenschwander ◽  
Lukas Schwingshackl ◽  
Sabrina Schlesinger
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Observational Studies ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Dietary Factors ◽  
Dietary Behaviour ◽  
Health Concern

IntroductionType 2 diabetes (T2D) is a major health concern associated with several comorbidities such as diabetic chronic kidney disease, neuropathy and cardiovascular diseases. Many of these complications may be preventable by an adequate lifestyle, including a favourable dietary behaviour, additionally to pharmacological management. In general, dietary guidelines for patients with diabetes recommend a hypocaloric diet to achieve a normal weight, but there is a lack of detailed instructions on specific nutrients and foods to prevent diabetes-related outcomes. Therefore, the aim of this systematic review and meta-analysis is to summarise the available evidence on the association between dietary factors and health-related outcomes in patients with T2D.Methods and analysisA systematic literature search will be conducted in PubMed and Web of Science in May 2019 to identify prospective observational studies investigating dietary factors in association with major complications in patients with T2D. We will include studies investigating dietary patterns, food groups, foods, macronutrients and micronutrients as well as secondary plant compounds. As diabetes-related outcomes, we will include macrovascular (cardiovascular and cerebrovascular diseases) and microvascular outcomes (nephropathy, neuropathy and retinopathy), as well as cancer, quality of life, depression, cognitive disorders and mortality. We will conduct dose-response meta-analyses using random effects models. We will investigate heterogeneity across studies and publication bias. To assess the risk of bias and quality of the included studies, we will use the Cochrane risk of bias tool ROBINS-I and the quality of evidence will be assessed using Grades of Recommendation, Assessment, Development, and Evaluation.Ethics and disseminationAs the systematic review is based on published studies, ethical considerations are not required. The systematic review and meta-analysis will be published in a peer-reviewed Journal.PROSPERO registration numberCRD42018110669

scholarly journals Effect of Oats and Oat-Fiber on Glycemic Control in Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 489-489
Author(s):  
Victoria Chen ◽  
Andreea Zurbau ◽  
Amna Ahmed ◽  
Tauseef Khan ◽  
Cyril Kendall ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Glycemic Control ◽  
Randomized Controlled Trials ◽  
Plasma Glucose ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Randomized Controlled

Abstract Objectives Current approved health claims in Canada, US and Europe recognize the ability of oat ß-glucan to lower blood cholesterol; however, its ability to improve glycemic control is less certain. We undertook a systematic review and meta-analysis of randomized controlled trials to update the evidence of the effect of oats and oat-fiber on markers of glycemic control in people with and without diabetes. Here we present data for the subgroup with diabetes. Methods MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials were searched through September 23rd, 2020. We included randomized controlled trials of ≥ 2-weeks of sources of oat ß-glucan and measures of glycemic control in diabetes. Two independent reviewers extracted relevant data and assessed the risk of bias (Cochrane Risk of Bias 2.0 Tool). The outcomes were fasting plasma glucose (FPG), 2h-plasma glucose (2h-PG) from a 75 g-oral glucose tolerance test, HbA1c and fasting plasma insulin (FPI). Data were pooled using the generic inverse variance method. Heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic). Pooled estimates were expressed as mean differences with 95% confidence intervals (CI). GRADE assessed the certainty of the evidence. Results Eligibility criteria were met by 5 trial comparisons (N = 359) in type 2 diabetes. No trials were identified in type 1 diabetes. Consumption of oat ß-glucan sources reduced FPG (MD = −0.37 mmol/L [95% CI: −0.70, −0.05 mmol/L], P = 0.03, I2 = 0.00%, PQ = 0.76) and 2h-PG (MD = −1.24 mmol/L [95% CI: −1.97, −0.51 mmol/L], P = 0.00, I2 = 0.00%, PQ = 0.56). There were non-significant reductions in HbA1c (MD = −0.12%, [95% CI: −0.26, 0.01%], P = 0.07, I2 = 0.00%, PQ = 1.00) and FPI (MD = −4.59 pmol/L, [95% CI: −14.71, 5.52 pmol/L], P = 0.37, I2 = 40.84%, PQ = 0.19). The certainty of evidence was high for 2h-PG and moderate for FPG, HbA1c and FPI (single downgrades for imprecision in each case). Conclusions Current evidence provides a good indication that consumption of oat ß-glucan results in small improvements of glycemic control in type 2 diabetes. More high quality randomized trials are required to improve the precision of the pooled estimates. (ClinicalTrials.gov identifier, NCT04631913) Funding Sources Quaker Oats Center of Excellence, Diabetes Canada, Banting & Best Diabetes Centre, Toronto 3D foundation

The Effectiveness of Mobile Phone Messaging-Based Interventions to Promote Physical Activity in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis (Preprint)

2021 ◽  
Author(s):  
Mohammed Alsahli ◽  
Alaa Abd-Alrazaq ◽  
Mowafa Househ ◽  
Stathis Konstantinidis ◽  
Holly Blake
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Systematic Review ◽  
Type 2 Diabetes ◽  
Meta Analysis ◽  
Text Messages ◽  
Risk Of Bias ◽  
Anthropometric Measures

BACKGROUND Type 2 diabetes mellitus (T2DM) is increasing in prevalence worldwide. Physical activity (PA) is an important aspect of self-care and first-line management for T2DM. Mobile text messages (SMS) can be used to support self-management in people with T2DM, but the effectiveness of mobile text messages-based interventions in increasing physical activity is still unclear. OBJECTIVE The study aimed to assess the effectiveness of mobile phone messaging on PA in people with T2DM by summarizing and pooling the findings of previous literature. METHODS A systematic review was conducted to accomplish this objective. Search sources included 5 bibliographic databases (MEDLINE, Cochrane Library, CINAHL, Web of Science, EMBASE), the search engine “Google Scholar”, and backward and forward reference list checking of the included studies and relevant reviews. Two reviewers independently carried out the study selection, data extraction, risk of bias assessment, and quality of evidence evaluation. Results of included studies were synthesized narratively and statistically, as appropriate. RESULTS We included 6 of 541 retrieved studies. Four of the studies showed a statistically significant effect of text messages on physical activity. Although a meta-analysis of results of two studies showed a statistically significant effect (P=.05) of text messages on physical activity, the effect was not clinically important. A meta-analysis of findings of 2 studies showed a non-significant effect (P=.14) of text messages on glycaemic control. Two studies found a non-significant effect of text messages on anthropometric measures (weight and BMI). CONCLUSIONS Text messaging interventions show promise for increasing physical activity. However, it is not possible to conclude from this review whether text messages have a significant effect on physical activity, glycaemic control, or anthropometric measures among patients with T2DM. This is due to the limited number of studies, the high overall risk of bias in most of the included studies and the low quality of meta-analysed evidence. There is a need for more high-quality primary studies.

scholarly journals Poor Quality of Dietary Assessment in Randomised Controlled Trials of Nutritional Interventions for Type 2 Diabetes May Impact Outcome Conclusions: A Systematic Review

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 64-64
Author(s):  
Tian Wang ◽  
George Siopis ◽  
Hiu Yee Wong ◽  
Margaret Allman-Farinelli
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trials ◽  
Dietary Assessment ◽  
Poor Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Nutritional Interventions ◽  
Randomized Controlled

Abstract Objectives Diet is critical in diabetes management and new nutritional interventions are continuously being tested in randomized controlled trials. However, to make meaningful conclusions about the efficacy of dietary treatments, it is critical to be certain that the participants adhered to the dietary intervention and the dietary changes are valid. The objective of this meta-analysis was to assess the quality of dietary assessment and whether it might impact on study metabolic outcomes. Methods Four databases, MEDLINE, EMBASE, CINAHL and CENTRAL, were searched, from inception until September 2019 for randomized controlled trials of nutritional interventions in people with non-insulin-dependent type 2 diabetes. Trials that measured nutritional intakes in methods and HbA1c as an outcome were included. Investigators assessed risk of bias and quality of the dietary measurements using the Cochrane Risk of Bias Assessment Tool 2.0 and a redeveloped EURICA tool, respectively. The study was conducted in accordance with the Preferred Reporting in Systematic Reviews and Meta-analyses. PROSPERO registration number: CRD42019146471. Results Of 2552 records retrieved, 23 studies met the inclusion criteria. Nineteen studies aimed to achieve a reduction in HbA1c, and four studies aimed to maintain HbA1c while improving other metabolic/nutritional outcomes. Two studies were rated as ‘good’, six as ‘medium’, and 15 as ‘poor’ in the quality assessment of the dietary measurement tool. The majority of studies were rated as high risk of bias. Of those studies with medium or high diet quality assessment, six of eight achieved the desired outcome whereas only four of the 15 other studies achieved the desired clinical outcome for HbA1c. Conclusions The poor quality of dietary assessment in clinical trials manipulating dietary intakes casts uncertainty on the legitimacy of causal mechanisms attributed to dietary interventions. Attention to the validity and reliability of dietary assessment methods is warranted. Funding Sources No funding support for conducting this review was received.

scholarly journals Withdrawal reasons of randomized controlled trials on type 2 diabetes: a systematic review

2021 ◽  
Author(s):  
Shahrzad Mohseni ◽  
Ozra Tabatabaei-Malazy ◽  
Maryam Peimani ◽  
Hanieh-Sadat Ejtahed ◽  
Mehrnoosh Khodaeian ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Randomized Controlled
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