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The Cochrane Database of Systematic... Jun 2023Diabetic retinopathy (DR) remains a major cause of sight loss worldwide, despite new therapies and improvements in the metabolic control of people living with diabetes.... (Review)
Review
BACKGROUND
Diabetic retinopathy (DR) remains a major cause of sight loss worldwide, despite new therapies and improvements in the metabolic control of people living with diabetes. Therefore, DR creates a physical and psychological burden for people, and an economic burden for society. Preventing the development and progression of DR, or avoiding the occurrence of its sight-threatening complications is essential, and must be pursued to save sight. Fenofibrate may be a useful strategy to achieve this goal, by reversing diabetes' effects and reducing inflammation in the retina, as well as improving dyslipidaemia and hypertriglyceridaemia. OBJECTIVES: To investigate the benefits and harms of fenofibrate for preventing the development and progression of diabetic retinopathy in people with type 1 (T1D) or type 2 diabetes (T2D), compared with placebo or observation.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, and three trials registers (February 2022).
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that included people with T1D or T2D, when these compared fenofibrate with placebo or with observation, and assessed the effect of fenofibrate on the development or progression of DR (or both).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods for data extraction and analysis. Our primary outcome was progression of DR, a composite outcome of 1) incidence of overt retinopathy for participants who did not have DR at baseline, or 2) advancing two or more steps on the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale for participants who had any DR at baseline (or both), based on the evaluation of stereoscopic or non-stereoscopic fundus photographs, during the follow-up period. Overt retinopathy was defined as the presence of any DR observed on stereoscopic or non-stereoscopic colour fundus photographs. Secondary outcomes included the incidence of overt retinopathy, reduction in visual acuity of participants with a reduction in visual acuity of 10 ETDRS letters or more, proliferative diabetic retinopathy, and diabetic macular oedema; mean vision-related quality of life, and serious adverse events of fenofibrate. We used GRADE to assess the certainty of evidence.
MAIN RESULTS
We included two studies and their eye sub-studies (15,313 participants) in people with T2D. The studies were conducted in the US, Canada, Australia, Finland, and New Zealand; follow-up period was four to five years. One was funded by the government, the other by industry. Compared to placebo or observation, fenofibrate likely results in little to no difference in progression of DR (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.60 to 1.25; 1 study, 1012 participants; moderate-certainty evidence) in a population with and without overt retinopathy at baseline. Those without overt retinopathy at baseline showed little or no progression (RR 1.00, 95% CI 0.68 to 1.47; 1 study, 804 participants); those with overt retinopathy at baseline found that their DR progressed slowly (RR 0.21, 95% CI 0.06 to 0.71; 1 study, 208 people; test for interaction P = 0.02). Compared to placebo or observation, fenofibrate likely resulted in little to no difference in either the incidence of overt retinopathy (RR 0.91; 95% CI 0.76 to 1.09; 2 studies, 1631 participants; moderate-certainty evidence); or the incidence of diabetic macular oedema (RR 0.39; 95% CI 0.12 to 1.24; 1 study, 1012 participants; moderate-certainty evidence). The use of fenofibrate increased severe adverse effects (RR 1.55; 95% CI 1.05 to 2.27; 2 studies, 15,313 participants; high-certainty evidence). The studies did not report on incidence of a reduction in visual acuity of 10 ETDRS letters or more, incidence of proliferative diabetic retinopathy, or mean vision-related quality of life.
AUTHORS' CONCLUSIONS
Current, moderate-certainty evidence suggests that in a mixed group of people with and without overt retinopathy, who live with T2D, fenofibrate likely results in little to no difference in progression of diabetic retinopathy. However, in people with overt retinopathy who live with T2D, fenofibrate likely reduces the progression. Serious adverse events were rare, but the risk of their occurrence was increased by the use of fenofibrate. There is no evidence on the effect of fenofibrate in people with T1D. More studies, with larger sample sizes, and participants with T1D are needed. They should measure outcomes that are important to people with diabetes, e.g. change in vision, reduction in visual acuity of 10 ETDRS letters or more, developing proliferative diabetic retinopathy; and evaluating the requirement of other treatments, e.g. injections of anti-vascular endothelial growth factor therapies, steroids.
Topics: Humans; Diabetic Retinopathy; Fenofibrate; Macular Edema; Diabetes Mellitus, Type 1; Retinal Diseases; Diabetes Mellitus, Type 2
PubMed: 37310870
DOI: 10.1002/14651858.CD013318.pub2 -
Diabetes Research and Clinical Practice Jan 2016Diabetes mellitus (DM) may be a risk factor for venous thromboembolism (VTE) but results are inconsistent. (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
Diabetes mellitus (DM) may be a risk factor for venous thromboembolism (VTE) but results are inconsistent.
AIM
We conducted a systematic review and meta-analysis of epidemiologic studies to quantify the association between DM and VTE.
METHODS AND RESULTS
We included studies identified in PubMed, Web of Science, and CINAHL through 07/31/2014. We identified 19 studies that met our selection criteria. We pooled RRs using a random-effects model: the pooled RR for the association of DM with VTE was 1.10 (95% CI: 0.94-1.29). Between-study heterogeneity was explored with a forest plot, funnel plot, meta-regression, and a stratified analysis. Between-study heterogeneity was observed and not explained by study design, method of DM assessment, or degree of adjustment for confounding. Sensitivity analyses omitted one study at a time to assess the influence of any single study on the pooled estimate. These analyses indicated that one large study was highly influential; when this study was excluded, the pooled estimate increased and just reached statistical significance: 1.16 (95% CI: 1.01-1.34).
CONCLUSIONS
This meta-analysis suggests either no association or a modest positive one between DM and VTE in the general population. DM is unlikely to play a major role in VTE development.
Topics: Diabetes Mellitus; Diabetic Angiopathies; Humans; Risk Factors; Venous Thromboembolism
PubMed: 26612139
DOI: 10.1016/j.diabres.2015.10.019 -
Scientific Reports Jan 2021Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore,... (Meta-Analysis)
Meta-Analysis
Studies have suggested that hyperbaric oxygen therapy (HBOT) is effective in the healing of diabetic foot ulcer (DFU); however, there is a lack of consensus. Therefore, to assess the efficacy of HBOT on diabetic foot ulcer among diabetic patients, controlled clinical trials were searched through PubMed, EMBASE, Clinical key, Ovid Discovery, ERMED, Clinical Trials.gov databases for randomized controlled trials (RCTs) and other sources until 15 September 2020. Studies that evaluated the effect of HBOT on diabetic foot ulcer, complete healing, amputation, adverse events, ulcer reduction area, and mortality rate were included. Of 1984 study records screened, 14 studies (768 participants) including twelve RCTs, and two CCTs were included as per inclusion criteria. The results with pooled analysis have shown that HBOT was significantly effective in complete healing of diabetic foot ulcer (OR = 0.29; 95% CI 0.14-0.61; I = 62%) and reduction of major amputation (RR = 0.60; 95% CI 0.39-0.92; I = 24%). Although, it was not effective for minor amputations (RR = 0.82; 95% CI 0.34-1.97; I = 79%); however, less adverse events were reported in standard treatment group (RR = 1.68; 95% CI 1.07-2.65; I = 0%). Nevertheless, reduction in mean percentage of ulcer area and mortality rate did not differ in HBOT and control groups. This review provides an evidence that hyperbaric oxygen therapy is effective as an adjunct treatment measure for the diabetes foot ulcers. These findings could be generalized cautiously by considering methodological flaws within all studies.
Topics: Amputation, Surgical; Controlled Clinical Trials as Topic; Diabetic Foot; Humans; Hyperbaric Oxygenation; Publication Bias; Risk; Treatment Outcome; Wound Healing
PubMed: 33500533
DOI: 10.1038/s41598-021-81886-1 -
Clinical Infectious Diseases : An... Mar 2017Despite the well-documented association between diabetes and active tuberculosis, evidence of the association between diabetes and latent tuberculosis infection (LTBI)... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Despite the well-documented association between diabetes and active tuberculosis, evidence of the association between diabetes and latent tuberculosis infection (LTBI) remains limited and inconsistent.
METHODS
We included observational studies that applied either the tuberculin skin test or the interferon gamma release assay for diagnosis of LTBI and that provided adjusted effect estimate for the association between diabetes and LTBI. We searched PubMed and EMBASE through 31 January 2016. The risk of bias of included studies was assessed using a quality assessment tool modified from the Newcastle-Ottawa scale.
RESULTS
Thirteen studies (1 cohort study and 12 cross-sectional studies) were included, involving 38263 participants. The cohort study revealed an increased but nonsignificant risk of LTBI among diabetics (risk ratio, 4.40; 95% confidence interval [CI], 0.50-38.55). For the cross-sectional studies, the pooled odds ratio from the random-effects model was 1.18 (95% CI, 1.06-1.30), with a small statistical heterogeneity across studies (I2, 3.5%). The risk of bias assessment revealed several methodological issues, but the overall direction of biases would reduce the positive causal association between diabetes and LTBI.
CONCLUSIONS
Diabetes was associated with a small but statistically significant risk for LTBI. Findings from this review could be used to inform future cost-effectiveness analysis on the impact of LTBI screening programs among diabetics.
Topics: Cohort Studies; Cross-Sectional Studies; Diabetes Complications; Diabetes Mellitus; Humans; Latent Tuberculosis; Odds Ratio; Publication Bias
PubMed: 27986673
DOI: 10.1093/cid/ciw836 -
Scientific Reports Mar 2021There is growing evidence for a role of maternal diabetes in the pathogenesis of neurodevelopmental disorders. However, the specific association between gestational... (Meta-Analysis)
Meta-Analysis
There is growing evidence for a role of maternal diabetes in the pathogenesis of neurodevelopmental disorders. However, the specific association between gestational diabetes (GDM), as opposed to pre-gestational diabetes, has been poorly isolated. Thus the aim was to systematically review and meta-analyse literature pertaining to prevalence and risk for two neurodevelopmental disorders: autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), when exposed to GDM. PubMed, Cochrane Library, EMBASE, PsycINFO and CINAHL were systematically searched for eligible literature, with forward and backward citation tracking. Screening for eligibility, risk of bias assessment and data extraction were performed by two independent reviewers. 18 studies measuring ASD and 15 measuring ADHD met inclusion criteria. On meta-analysis there was an increased risk of ASD (OR 1.42; 95% CI 1.22, 1.65) but not ADHD (OR 1.01; 95% CI 0.79, 1.28). We discuss potential mechanisms for these differing risks. Greater understanding of risk factors, including GDM, for these neurodevelopmental disorders and potential mechanisms may help inform strategies aimed at prevention of exposure to these adversities during pregnancy.
Topics: Adolescent; Adult; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Child; Child, Preschool; Diabetes Complications; Diabetes, Gestational; Female; Humans; Male; Pregnancy; Risk Factors
PubMed: 33664319
DOI: 10.1038/s41598-021-84573-3 -
Frontiers in Immunology 2023Diabetic kidney disease (DKD) is a chronic inflammatory condition that affects approximately 20-40% of individuals with diabetes. Sodium-glucose co-transporter 2... (Review)
Review
Diabetic kidney disease (DKD) is a chronic inflammatory condition that affects approximately 20-40% of individuals with diabetes. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors, emerging as novel hypoglycemic agents, have demonstrated significant cardiorenal protective effects in patients with DKD. Initially, it was believed that the efficacy of SGLT-2 inhibitors declined as the estimated glomerular filtration rate (eGFR) decreased, which led to their preferential use in DKD patients at G1-G3 stages. However, recent findings from the DAPA-CKD and EMPA-KIDNEY studies have revealed equally beneficial cardiorenal effects of SGLT-2 inhibitors in individuals at stage G4 DKD, although the underlying mechanism behind this phenomenon remains unclear. In this comprehensive analysis, we provide a systematic review of the mechanisms and functioning of SGLT-2 inhibitors, potential renal protection mechanisms, and the therapeutic efficacy and safety of SGLT-2 inhibitors in kidney diseases, with a particular focus on stage G4 DKD. Gaining a deeper understanding of the renal protective effect of SGLT-2 inhibitors and their underlying mechanisms is highly significance for the successful utilization of these inhibitors in the treatment of diverse kidney disorders.
Topics: Humans; Sodium-Glucose Transporter 2 Inhibitors; Diabetic Nephropathies; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Kidney
PubMed: 37809091
DOI: 10.3389/fimmu.2023.1213473 -
Minerva Medica Aug 2021The antimicrobial trimethoprim is structurally related to potassium-sparing diuretics and may consequently lead to derangements in electrolyte and acid-base balance....
INTRODUCTION
The antimicrobial trimethoprim is structurally related to potassium-sparing diuretics and may consequently lead to derangements in electrolyte and acid-base balance. Since no report so far analyzed the literature documenting individual cases with electrolyte and acid-base derangements induced by trimethoprim, a systematic review was carried out.
EVIDENCE ACQUISITION
We retained 53 reports documenting 68 cases (42 males and 26 females 23 to 96 years of age) of electrolyte or acid-base derangements occurring on trimethoprim for about 5 days.
EVIDENCE SYNTHESIS
One hundred five electrolyte imbalances were detected in the 68 patients: hyperkalemia (>5.0 mmol/L) in 62 (91%), hyponatremia (<135 mmol/L) in 29 (43%) and metabolic acidosis (pH<7.38 and bicarbonate <19 mmol/L) in 14 (21%) cases. Following possible predisposing factors for electrolyte and acid-base abnormalities were found in 54 (79%) patients: high-dose trimethoprim, comedication with drugs that have been associated with electrolyte and acid-base derangements, preexisting kidney disease, age ≥80 years and diabetes mellitus.
CONCLUSIONS
High-dose trimethoprim, comedicated with drugs that have been associated with electrolyte and acid-base derangements, poor kidney function, age ≥80 years and diabetes mellitus predispose to trimethoprim-associated electrolyte and acid-base abnormalities. Clinicians must recognize patients at risk, possibly avoid drug combinations that may worsen the problem and monitor the laboratory values.
Topics: Acidosis; Adult; Aged; Aged, 80 and over; Anti-Infective Agents, Urinary; Bicarbonates; Diabetes Complications; Female; Humans; Hyperkalemia; Hyponatremia; Kidney Diseases; Male; Middle Aged; Trimethoprim; Young Adult
PubMed: 32697061
DOI: 10.23736/S0026-4806.20.06660-4 -
Frontiers in Public Health 2022The relationship between uric acid (UA) and diabetic retinopathy (DR) remains ambiguous, and the results of current studies on the UA levels in patients with DR are... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The relationship between uric acid (UA) and diabetic retinopathy (DR) remains ambiguous, and the results of current studies on the UA levels in patients with DR are conflicting. A meta-analysis was performed to provide a better understanding of the relationship between UA levels and DR.
METHODS
PubMed, Web of Science, Embase, and the Cochrane Library databases were searched until December 11, 2021 to identify eligible studies, that compared the UA levels of the case group (patients with DR) and control group (controls with diabetes and healthy participants). The weighted mean difference (WMD) with a 95% confidence interval (CI) was used to evaluate the difference in UA levels between the case and control groups.
RESULTS
Twenty-one studies involving 4,340 patients with DR and 8,595 controls (8,029 controls with diabetes and 566 healthy participants) were included in this meta-analysis. We found that patients with DR had significantly higher UA levels than those in the controls with diabetes (WMD = 36.28; 95% CI: 15.68, 56.89; < 0.001) and healthy participants (WMD = 70.80; 95% CI: 19.85, 121.75; = 0.006). There was an obvious heterogeneity among the 21 studies ( = 97%, < 0.001). Subgroup analyses of different phases of DR showed that UA levels were significantly increased in participants with proliferative diabetic retinopathy (PDR) (WMD = 46.57; 95% CI: 28.51, 64.63; < 0.001) than in controls with diabetes; however, the difference is not statistically significant when comparing UA levels in patients with non-proliferative diabetic retinopathy (NPDR) and controls with diabetes (WMD = 22.50; 95% CI: -6.07, 51.08; = 0.120). In addition, UA levels were higher in participants with a body mass index (BMI) ≥25.0 kg/m and over 15 years of diabetes. Univariate meta-regression analysis revealed that BMI ( = 0.007, Adj = 40.12%) and fasting blood glucose (FBG) ( = 0.040, Adj = 29.72%) contributed to between-study heterogeneity.
CONCLUSIONS
In conclusion, our study provides evidence that UA levels are higher in patients with DR than those in the controls, but this difference is not statistically significant in the early phases. UA might be a potential biomarker for identifying disease severity in patients with DR, rather than predicting the onset of DR among patients with diabetes. However, more prospective and high-quality clinical evidence is required to confirm these present findings.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=297708.
Topics: Biomarkers; Diabetes Mellitus; Diabetic Retinopathy; Humans; Prospective Studies; Severity of Illness Index; Uric Acid
PubMed: 35712295
DOI: 10.3389/fpubh.2022.906760 -
European Journal of Vascular and... Nov 2023Free tissue transfer is a powerful reconstructive method for patients with substantial diabetic foot ulcers. This study aimed to perform an updated systematic review and... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Free tissue transfer is a powerful reconstructive method for patients with substantial diabetic foot ulcers. This study aimed to perform an updated systematic review and meta-analysis investigating the flap characteristics, concurrent revascularisation rates, complications, and outcomes associated with free tissue transfer in diabetic foot ulcers.
METHODS
Two reviewers performed a systematic review of various databases since their inception, with no language restriction. Only data for free tissue transfer in non-traumatic diabetic foot ulcer patients were extracted from included studies where a heterogeneous population was studied. Outcome data were pooled using random effects meta-analysis for binomial data.
RESULTS
Of 632 studies identified, 67 studies encompassing 1 846 patients and 1 871 free flaps were included. A median of 18 patients [IQR 9, 37] per study, with a median age of 58.5 years [56, 63], were followed up for a median of 15 months [7, 25]. Most studies had serious risk of bias (n = 47 studies, 70%); sixteen (24%) had moderate risk of bias; and four (6%) had low risk of bias. The proportion of patients who underwent revascularisation was 75% (95% CI 60 - 87%; n = 36 studies) with a median time of 8 days between procedures. The pooled complete flap survival, major amputation, and ambulation rates were 88% (85 - 92%, n = 49 studies), 10% (7 - 14%, n = 50 studies), and 87% (80 - 92%, n = 36 studies), respectively. Death at individual study follow up was 6% (3 - 10%, n = 26 studies). The overall certainty of evidence was very low.
CONCLUSION
Free tissue transfer may be a useful treatment modality for recalcitrant diabetic foot ulcers in selected patients. Future studies should investigate long term functional outcomes and aim to develop patient selection algorithms to select the most suitable candidates for this procedure.
Topics: Humans; Middle Aged; Diabetic Foot; Plastic Surgery Procedures; Free Tissue Flaps; Vascular Surgical Procedures; Amputation, Surgical; Diabetes Mellitus
PubMed: 37500000
DOI: 10.1016/j.ejvs.2023.07.031 -
Journal of Dental Research Sep 2014The aim of this systematic review and meta-analysis was to investigate whether there are any effects of diabetes mellitus on implant failure rates, postoperative... (Meta-Analysis)
Meta-Analysis Review
The aim of this systematic review and meta-analysis was to investigate whether there are any effects of diabetes mellitus on implant failure rates, postoperative infections, and marginal bone loss. An electronic search without time or language restrictions was undertaken in March 2014. The present review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligibility criteria included clinical human studies. The search strategy resulted in 14 publications. The I (2) statistic was used to express the percentage of total variation across studies due to heterogeneity. The inverse variance method was used for the random effects model when heterogeneity was detected or for the fixed effects model when heterogeneity was not detected. The estimates of an intervention for dichotomous outcomes were expressed in risk ratio and in mean difference in millimeters for continuous outcomes, both with a 95% confidence interval. There was a statistically significant difference (p = .001; mean difference = 0.20, 95% confidence interval = 0.08, 0.31) between diabetic and non-diabetic patients concerning marginal bone loss, favoring non-diabetic patients. A meta-analysis was not possible for postoperative infections. The difference between the patients (diabetic vs. non-diabetic) did not significantly affect implant failure rates (p = .65), with a risk ratio of 1.07 (95% confidence interval = 0.80, 1.44). Studies are lacking that include both patient types, with larger sample sizes, and that report the outcome data separately for each group. The results of the present meta-analysis should be interpreted with caution because of the presence of uncontrolled confounding factors in the included studies.
Topics: Alveolar Bone Loss; Dental Implants; Dental Restoration Failure; Diabetes Complications; Humans; Surgical Wound Infection
PubMed: 24928096
DOI: 10.1177/0022034514538820