All-cause mortality and cardiovascular safety of basal insulin treatment in patients with type 2 diabetes mellitus: A systematic review with meta-analysis and trial sequential analysis.

AIM: To evaluate the risk of all-cause and cardiovascular mortality, acute myocardial infarction, and stroke associated with insulin treatment in patients with type 2 diabetes. METHODS: A systematic review with meta-analysis of randomized clinical trials (RCTs) was performed. EMBASE, Cochrane, and PubMed databases were searched for RCTs reporting mortality or cardiovascular events and comparing basal insulin to any treatment in patients with type 2 diabetes. Data were summarized with Mantel-Haenzel relative risk (RR). Trial sequential analysis (TSA) was used to evaluate the reliability of the results considering a 20% relative risk difference between treatments. PROSPERO Registry: CRD42018087336. RESULTS: In total, 2351 references were identified, and 26 studies (24348 patients) were included. Most studies evaluated glargine insulin (69%), compared insulin to GLP-1 analogs (57%), and evaluated add-on therapy with metformin (77%). Insulin was not associated with increased all-cause mortality (RR 0.99; 95% confidence interval (CI) 0.92-1.06), cardiovascular mortality (RR 1.01; 95% CI 0.91-1.13), myocardial infarction (RR 1.02; 95% CI 0.92-1.15), or stroke (RR 0.87; 95% CI 0.68-1.12). Insulin treatment increased severe hypoglycemia risk (RR 2.98; 95% CI 2.47-3.61). All analyses had low statistical heterogeneity. TSA confirmed these findings: optimal sample size (myocardial infarction), futility boundary (all-cause mortality, cardiovascular mortality, and stroke) and harm boundary (hypoglycemia) were reached. CONCLUSION: Treatment with basal insulin of patients with type 2 diabetes does not increase the risk of cardiovascular events or death. Despite the increased risk of hypoglycemia, these findings reinforce that insulin is a safe option in the treatment of type 2 diabetes.

Metabolic effects of antihyperglycemic agents and mortality: meta-analysis of randomized controlled trials.

The effects of antihyperglycemic medications on cardiovascular events and mortality are heterogeneous and their effects on intermediate factors might explain these differences. This systematic review explores the relationship between metabolic factors, mechanism of action, and mortality effects of antihyperglycemic medications in type 2 diabetes. Randomized trials assessing the effects of antihyperglycemic medications on all-cause or cardiovascular mortality in type 2 diabetes were included. Myocardial infarction, stroke, and heart failure were secondary outcomes. The effects of medications on HbA1c, severe hypoglycemia (SH), body weight, systolic blood pressure (SBP), and mechanism of action were evaluated. Meta-analyses and meta-regressions were performed grouping studies according to the above-cited factors. All-cause mortality was lower for medications that reduced HbA1c, SH, body weight, and SBP. Decreased cardiovascular mortality was associated with lower HbA1c, SH, SBP. Myocardial infarction and stroke were also associated with favorable metabolic profile. These findings were not confirmed in meta-regression models. Medications associated with lower SH, body weight and SBP had a lower risk of heart failure. In conclusion, medications with better metabolic profile were associated with reduced all-cause and cardiovascular mortality. These findings are based on indirect comparisons and must be applied cautiously.

Low linolenic and linoleic acid consumption are associated with chronic kidney disease in patients with type 2 diabetes.

AIM: This cross-sectional study aimed to assess the association of the fat content in the diet with Diabetic Kidney Disease (DKD) in patients with type 2 diabetes. METHODOLOGY: Patients from the Diabetes research clinic at Hospital de Clínicas de Porto Alegre (Brazil) were consecutively recruited. The inclusion criterion was the diagnosis of type 2 diabetes. The exclusion criteria were as follows: body mass index >40 kg/m2, heart failure, gastroparesis, diabetic diarrhea, dietary counseling by a registered dietitian during the previous 12 months, and inability to perform the weighed diet records (WDR). The dietary fatty acids (saturated, monounsaturated and polyunsaturated) consumption was estimated by 3-day WDR. Compliance with the WDR technique was assessed by comparison of protein intake estimated from the 3-day WDR and from the 24-h urinary nitrogen output performed on the third day of the WDR period. The presence of DKD was defined as urinary albumin excretion (UAE) ≥ 30 mg / 24 h or/and glomerular filtration rate (eGFR) <60 ml/min/1.73 m2. Urinary albumin was measured twice and eGFR was estimated by using the CKD-EPI equation. RESULTS: A total of 366 patients were evaluated; of these, 33% (n = 121) had DKD. Multivariate analysis showed that the intake of linolenic acid was negatively associated with DKD (OR = 0.57; 95% CI 0.35-0.93; P = 0.024), adjusted for gender, smoking, cardiovascular disease, ACE inhibitors and/or angiotensin receptor blocker use, systolic blood pressure, fasting plasma glucose and HDL cholesterol. In a separate model, similar results were observed for linoleic acid, adjusting to the same co-variables (OR = 0.95; 95% CI 0.91-0.99; P = 0.006). CONCLUSION: The lower intake of polyunsaturated fatty acids, especially linolenic and linoleic acid, is associated with chronic kidney disease in patients with type 2 diabetes.

Association between metabolic syndrome and periodontitis: a systematic review and meta-analysis.

The aim of the present study was to evaluate the association between metabolic syndrome (MS) and periodontitis (PD), through a systematic review and meta-analysis. Original observational studies assessing the association between MS and PD in adults, published before May 11th (2017), were identified through electronic searches of MEDLINE, EMBASE and Cochrane Library databases. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline was used. For studies to be included, they had to mention the criteria used to diagnose MS and to have used at least one clinical measure to diagnose PD. There was no language restriction. Three reviewers independently identified eligible studies for possible inclusion in the systematic review and meta-analysis. The quality of the studies was evaluated by the Newcastle-Ottawa scale for observational studies. A random model meta-analysis was conducted. The strategies used to investigate heterogeneity were sequential analysis, subgroup analysis, univariate meta-regression and sensitivity analysis. Thirty-three studies met the inclusion criteria for the systematic review, and 26 had enough information to be included in the meta-analysis, totaling 52,504 patients. MS and PD were associated with an odds ratio of 1.38 (95%CI 1.26-1.51; I2 = 92.7%; p < 0.001). Subgroup analysis showed that complete periodontal examination (I2 = 70.6%; p < 0.001) partially explained the variability between studies. The present findings suggest an association between MS and PD. Individuals with MS are 38% more likely to present PD than individuals without this condition. Prospective studies should be conducted to establish cause and effect relations between MS and PD.

Association between metabolic syndrome and periodontitis: a systematic review and meta-analysis

Abstract The aim of the present study was to evaluate the association between metabolic syndrome (MS) and periodontitis (PD), through a systematic review and meta-analysis. Original observational studies assessing the association between MS and PD in adults, published before May 11th (2017), were identified through electronic searches of MEDLINE, EMBASE and Cochrane Library databases. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guideline was used. For studies to be included, they had to mention the criteria used to diagnose MS and to have used at least one clinical measure to diagnose PD. There was no language restriction. Three reviewers independently identified eligible studies for possible inclusion in the systematic review and meta-analysis. The quality of the studies was evaluated by the Newcastle-Ottawa scale for observational studies. A random model meta-analysis was conducted. The strategies used to investigate heterogeneity were sequential analysis, subgroup analysis, univariate meta-regression and sensitivity analysis. Thirty-three studies met the inclusion criteria for the systematic review, and 26 had enough information to be included in the meta-analysis, totaling 52,504 patients. MS and PD were associated with an odds ratio of 1.38 (95%CI 1.26-1.51; I2 = 92.7%; p < 0.001). Subgroup analysis showed that complete periodontal examination (I2 = 70.6%; p < 0.001) partially explained the variability between studies. The present findings suggest an association between MS and PD. Individuals with MS are 38% more likely to present PD than individuals without this condition. Prospective studies should be conducted to establish cause and effect relations between MS and PD.

Low Levels of Usual Physical Activity Are Associated with Higher 24 h Blood Pressure in Type 2 Diabetes Mellitus in a Cross-Sectional Study.

The aim of this study is to evaluate the association between usual physical activity and 24 h blood pressure (BP) profile in people with type 2 diabetes mellitus (DM). This is a cross-sectional study of 151 participants with type 2 DM. Usual physical activity was assessed by step counting and self-reported questionnaire. BP was measured in office and by 24 h ambulatory BP monitoring (ABPM; 24 h, daytime and nighttime). Mean participant age was 61.1 ± 8.4 years, 64% was women, and mean duration of diabetes was 14.3 ± 8.5 years. Ninety-two percent of participants had hypertension, and office BP was 138 ± 18/78 ± 10 mmHg. Inverse correlations were observed between step count and 24 h BP (systolic, r = -0.186; p = 0.022), daytime BP (systolic, r = -0.198; p = 0.015), and nighttime BP (pulse pressure, r = -0.190; p = 0.019). People were categorized into tertiles of daily step count, and the 1st tertile had higher 24 h systolic BP, daytime systolic BP, daytime mean BP, and daytime systolic BP load than those in the other tertiles, even after adjusting for age and HbA1c. Participants with type 2 DM and low levels of physical activity exhibit higher 24 h and daytime systolic ambulatory BP values as compared with those who performed more steps per day, even after adjustments for confounding factors.

Once weekly glucagon-like peptide-1 receptor agonist albiglutide vs. prandial insulin added to basal insulin in patients with type 2 diabetes mellitus: Results over 52 weeks.

We have previously reported that once-weekly albiglutide was noninferior to thrice-daily lispro for glycemic lowering, with decreased weight and risk of hypoglycemia, in patients inadequately controlled on basal insulin over 26 weeks. Findings after 52 weeks reveal similar responses to albiglutide as an add-on to insulin glargine.

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial.

BACKGROUND: Community health workers are community members who provide education and care for patients for a broad range of health issues, including diabetes mellitus. However, few community health workers are trained for diabetes education and little is known about the effectiveness of their interventions. The aim of this study is to evaluate the effect of a diabetes education program delivered to community health workers in improving the metabolic control of patients with type 2 diabetes mellitus. METHODS: Eight community health workers, providing care for 118 patients, were randomized in two groups to receive a 1-month diabetes education program (intervention, patients n = 62) or an education course in other health issues (control, patients n = 56). Each community health worker was responsible for transmitting the acquired knowledge to patients. Primary outcome was changed in HbA1C 3 months after the intervention. RESULTS: PARTICIPANTS: Mean age was 61 ± 11 years, 35% were men and 62% were whites. HbA1c levels reduced in both groups (intervention: 9.1 ± 2.2 vs. 7.9 ± 1.9%; control: 9.1 ± 2.1 vs. 8.4 ± 2.5%, p < 0.001), but no statistically significant differences were observed between groups (p between groups = 0.13). Total cholesterol (intervention: 192 ± 43 vs. 182 ± 39 mg/dl; control: 197 ± 44 vs. 191 ± 45 mg/dl, p between groups = 0.035) and triglycerides (intervention: 158 [106-218] vs. 135 [106-215]; control: 128 [100-215] mg/dl vs. 146 [102-203] mg/dl, p between groups = 0.03) reduced overtime only in intervention group. CONCLUSIONS: In this study, a significant decrease in HbA1c was observed during patients' follow-up, but it was similar in intervention and control groups. The diabetes mellitus education course delivered to community health workers was able to improve patients' lipid profile.

Effect of ethnicity on HbA1c levels in individuals without diabetes: Systematic review and meta-analysis.

AIMS/HYPOTHESIS: Disparities in HbA1c levels have been observed among ethnic groups. Most studies were performed in patients with diabetes mellitus (DM), which may interfere with results due to the high variability of glucose levels. We conducted a systematic review and meta-analysis to investigate the effect of ethnicity on HbA1c levels in individuals without DM. METHODS: This is a systematic review with meta-analysis. We searched MEDLINE and EMBASE up to September 2016. Studies published after 1996, performed in adults without DM, reporting HbA1c results measured by certified/standardized methods were included. A random effects model was used and the effect size was presented as weighted HbA1c mean difference (95% CI) between different ethnicities as compared to White ethnicity. RESULTS: Twelve studies met the inclusion criteria, totalling data from 49,238 individuals. There were significant differences between HbA1c levels in Blacks [0.26% (2.8 mmol/mol); 95% CI 0.18 to 0.33 (2.0 to 3.6), p <0.001; I2 = 90%, p <0.001], Asians [0.24% (2.6 mmol/mol); 95% CI 0.16 to 0.33 (1.7 to 3.6), p <0.001; I2 = 80%, p = 0.0006] and Latinos [0.08% (0.9 mmol/mol); IC 95% 0.06 to 0.10 (0.7 to 1.1); p <0.001; I2 = 0%; p = 0.72] when compared to Whites. CONCLUSIONS/INTERPRETATION: This meta-analysis shows that, in individuals without DM, HbA1c values are higher in Blacks, Asians, and Latinos when compared to White persons. Although small, these differences might have impact on the use of a sole HbA1c point to diagnose DM in all ethnic populations.

Correction: The Association between Sulfonylurea Use and All-Cause and Cardiovascular Mortality: A Meta-Analysis with Trial Sequential Analysis of Randomized Clinical Trials.

[This corrects the article DOI: 10.1371/journal.pmed.1001992.].

Diabetes education in primary care: a randomized clinical trial.

The aim of the study was to evaluate the effect of a structured group education program administered by a primary care nurse in patients with type 2 diabetes mellitus. The sample included 137 patients with type 2 diabetes mellitus, randomized into two groups: intervention (5-week educational course and reinforcements every 4 months for one year) and control (with no structured diabetes mellitus education) with an evaluation of metabolic control, weight, blood pressure, distress scores, and knowledge on diabetes. There were no differences between the two groups in HbA1c at 4, 8, or 12 months when compared to baseline values. An increase in HbA1c was observed in the control group after adjusting for baseline HbA1c and insulin dose (p = 0.044 between groups). Knowledge scores and diabetes-related distress improved after the intervention. A structured educational program administered to type 2 diabetes mellitus patients seen at a primary care unit improved the knowledge and distress associated with the disease. The results also suggest the prevention of an increase in HbA1c.

The Association between Sulfonylurea Use and All-Cause and Cardiovascular Mortality: A Meta-Analysis with Trial Sequential Analysis of Randomized Clinical Trials.

BACKGROUND: Sulfonylureas are an effective and inexpensive treatment for type 2 diabetes. There is conflicting data about the safety of these drugs regarding mortality and cardiovascular outcomes. The objective of the present study was to evaluate the safety of the sulfonylureas most frequently used and to use trial sequential analysis (TSA) to analyze whether the available sample was powered enough to support the results. METHODS AND FINDINGS: Electronic databases were reviewed from 1946 (Embase) or 1966 (MEDLINE) up to 31 December 2014. Randomized clinical trials (RCTs) of at least 52 wk in duration evaluating second- or third-generation sulfonylureas in the treatment of adults with type 2 diabetes and reporting outcomes of interest were included. Primary outcomes were all-cause and cardiovascular mortality. Additionally, myocardial infarction and stroke events were evaluated. Data were summarized with Peto odds ratios (ORs), and the reliability of the results was evaluated with TSA. Forty-seven RCTs with 37,650 patients and 890 deaths in total were included. Sulfonylureas were not associated with all-cause (OR 1.12 [95% CI 0.96 to 1.30]) or cardiovascular mortality (OR 1.12 [95% CI 0.87 to 1.42]). Sulfonylureas were also not associated with increased risk of myocardial infarction (OR 0.92 [95% CI 0.76 to 1.12]) or stroke (OR 1.16 [95% CI 0.81 to 1.66]). TSA could discard an absolute difference of 0.5% between the treatments, which was considered the minimal clinically significant difference. The major limitation of this review was the inclusion of studies not designed to evaluate safety outcomes. CONCLUSIONS: Sulfonylureas are not associated with increased risk for all-cause mortality, cardiovascular mortality, myocardial infarction, or stroke. Current evidence supports the safety of sulfonylureas; an absolute risk of 0.5% could be firmly discarded. REVIEW REGISTRATION: PROSPERO CRD42014004330.

Diabetes education in primary care: a randomized clinical trial / Educação em diabetes na atenção primária: um ensaio clínico randomizado / Educación sobre diabetes en la atención primaria: un ensayo clínico aleatorizado

Abstract: The aim of the study was to evaluate the effect of a structured group education program administered by a primary care nurse in patients with type 2 diabetes mellitus. The sample included 137 patients with type 2 diabetes mellitus, randomized into two groups: intervention (5-week educational course and reinforcements every 4 months for one year) and control (with no structured diabetes mellitus education) with an evaluation of metabolic control, weight, blood pressure, distress scores, and knowledge on diabetes. There were no differences between the two groups in HbA1c at 4, 8, or 12 months when compared to baseline values. An increase in HbA1c was observed in the control group after adjusting for baseline HbA1c and insulin dose (p = 0.044 between groups). Knowledge scores and diabetes-related distress improved after the intervention. A structured educational program administered to type 2 diabetes mellitus patients seen at a primary care unit improved the knowledge and distress associated with the disease. The results also suggest the prevention of an increase in HbA1c.

Resumo: O objetivo deste estudo foi avaliar o efeito de um programa de educação estruturado em grupo, aplicado por enfermeira de cuidados primários a pacientes com diabetes mellitus tipo 2. A amostra contou com 137 pacientes com diabetes mellitus tipo 2, randomizados em dois grupos: intervenção, (curso educativo de cinco semanas e reforços a cada 4 meses, durante um ano) e grupo controle (sem educação estruturada) com avaliação do controle metabólico, peso, pressão arterial, escores de estresse e conhecimento relacionados ao diabetes. Não houve diferenças entre os grupos na HbA1c em 4, 8 ou 12 meses, quando comparado aos valores basais. Foi observado um incremento na HbA1c no grupo controle após ajustes para HbA1c no basal e dose de insulina (p = 0,044 entre grupos). Os escores de conhecimento e estresse relacionados ao diabetes melhoraram após a intervenção. Um programa educacional estruturado ministrado à pacientes com diabetes mellitus tipo 2 atendidos em atenção primaria melhorou o conhecimento e estresse associados à doença. Além disso, nossos resultados sugerem uma prevenção de elevação da HbA1c.

Resumen: El objetivo de este estudio fue evaluar el efecto de un programa de educación estructurada en grupo, aplicado por la enfermera de atención primaria para pacientes con diabetes mellitus tipo 2. La muestra incluyó a 137 pacientes con diabetes mellitus tipo 2, aleatorizados en dos grupos: intervención (curso de formación de 5 semanas, com refuerzos cada 4 meses durante un año) y el grupo de control (sin educación estructurada) para evaluar el control metabólico, peso, presión arterial, niveles de estrés y conocimientos relacionados con la diabetes. No hubo diferencias entre los grupos en HbA1c en 4, 8 ó 12 meses en comparación con los valores basales. Se observó un aumento de HbA1c en el grupo de control después del ajuste de HbA1c en la línea de base y a la dosis de la insulina (p = 0,044 entre grupos). Las puntuaciones de los conocimientos y del estrés relacionadas con la diabetes mejoraron después de la intervención. Un programa educativo estructurado ofrecido a los pacientes con diabetes mellitus tipo 2 tratados en la atención primaria mejoró el conocimiento y el estrés asociado con la enfermedad. Por otra parte, nuestros resultados sugieren una prevención elevada de la HbA1c.

Clinical use of insulin degludec.

The limitations of current basal insulin preparations include concerns related to their pharmacokinetic and pharmacodynamic properties, hypoglycaemia, weight gain, and perception of management complexity, including rigid dosing schedules. Insulin degludec (IDeg) is a novel basal insulin with improved pharmacokinetic and pharmacodynamic properties compared to insulin glargine (IGlar) including a long half-life of ∼25 h and a duration of action >42 h at steady state, providing a flat and stable blood glucose-lowering effect when injected once daily. Evidence from phase 3a clinical trials with a treat-to-target design in patients with type 1 and type 2 diabetes has shown that IDeg has similar efficacy to IGlar, with a 9% and 26% reduction in risk of overall and nocturnal hypoglycaemia, respectively (in the pooled population) during the entire treatment period, and a 16% and 32% reduction during the maintenance period, respectively. Given its pharmacodynamic properties, IDeg offers a broad dosing window, allowing for flexible dose administration, if required. Two different formulations of IDeg are available (100 units/mL [U100] and 200 units/mL), the latter providing the same IDeg dose as the U100 formulation in half the injection volume. The unique pharmacokinetic profile of IDeg facilitates glycaemic control while minimising the risk of nocturnal hypoglycaemia.

Factors affecting A1C in non-diabetic individuals: Review and meta-analysis.

We carried out a systematic review and meta-analyses of studies that evaluated the possible effects of anemia, variant hemoglobin, and uremia on A1C levels in individuals without diabetes (DM). Medline and Embase were searched for studies that measured A1C values in groups with and without iron deficiency anemia (IDA) and/or iron deficiency (ID), variant hemoglobin and/or uremia by standardized methods. The difference between A1C levels in the groups with and without interferences was obtained by using random-effects meta-analysis and the effect size was presented as absolute difference of means (95% CI). Ten studies fulfilled the inclusion criteria, providing data from 11,176 participants without DM. There were no statistically significant differences in A1C in the presence of IDA/ID, HbS, and uremia by HPLC and uremia by immunoassay [0.79% (95% IC -0.39; 1.97), -0.13% (95% IC -0.51; 0.26), 0.15% (95% CI -0.58; 0.88) and -0.19% (95% CI -0.78; 0.40), respectively]. The effects of HbAS and uremia on A1C levels are within the expected individual variation and should not affect A1C results to diagnose DM. However, the effects of IDA/ID remain inconclusive and further studies are needed to clarify the glycation mechanisms in individuals with IDA/ID without diabetes.

Thyroid ultrasound features and risk of carcinoma: a systematic review and meta-analysis of observational studies.

BACKGROUND: Thyroid nodules are a common finding in the general population, and their detection is increasing with the widespread use of ultrasound (US). Thyroid cancer is found in 5-15% of cases depending on sex, age, and exposure to other risk factors. Some US parameters have been associated with increased risk of malignancy. However, no characteristic seems sufficiently reliable in isolation to diagnose malignancy. The objective of this meta-analysis was to evaluate the diagnostic performance of US features for thyroid malignancy in patients with unselected thyroid nodules and nodules with indeterminate fine-needle aspiration (FNA) cytology. METHODS: Electronic databases were reviewed for studies published prior to July 2012 that evaluated US features of thyroid nodules and reported postoperative histopathologic diagnosis. A manual search of references of review and key articles, and previous meta-analyses was also performed. A separate meta-analysis was performed including only nodules with indeterminate cytology. Analyzed features were solid structure, hypoechogenicity, irregular margins, absence of halo, microcalcifications, central vascularization, solitary nodule, heterogeneity, taller than wide shape, and absence of elasticity. RESULTS: Fifty-two observational studies (12,786 nodules) were included. Nine studies included nodules with indeterminate cytology as a separate category, comprising 1851 nodules. In unselected nodules, all US features were significantly associated with malignancy with an odds ratio varying from 1.78 to 35.7, and microcalcifications, irregular margins, and a taller than wide shape had high specificities (Sp; 87.8%, 83.1%, 96.6%) and positive likelihood ratios (LHR; 3.26, 2.99, 8.07). Absence of elasticity was the single feature with the best diagnostic performance (sensitivity 87.9%, Sp 86.2%, and positive LHR 6.39). The presence of central vascularization was the most specific US feature in nodules with indeterminate cytology (Sp 96% and positive LHR 2.13). CONCLUSIONS: US features in isolation do not provide reliable information to select nodules that should have a FNA performed. A combination of US characteristics with higher likelihood ratios and consequently with higher post-test probabilities of malignancy-microcalcifications, or a taller than wide shape, or irregular margins, or absence of elasticity-will probably identify nodules with an increased risk for malignancy. Further studies are required to standardize elastography techniques and evaluate outcomes, especially in nodules with an indeterminate cytology.

Dietary intervention in patients with gestational diabetes mellitus: a systematic review and meta-analysis of randomized clinical trials on maternal and newborn outcomes.

OBJECTIVE: Diet is the cornerstone treatment of patients with gestational diabetes mellitus (GDM), but its role in maternal and newborn outcomes has been scarcely studied. The purpose of this study was to analyze the efficacy of dietary interventions on maternal or newborn outcomes in patients with GDM. RESEARCH DESIGN AND METHODS: A systematic review and meta-analysis of randomized clinical trials (RCTs) of dietary intervention in GDM or pregnancy with hyperglycemia was performed. MEDLINE, Embase, ClinicalTrials.gov, Cochrane, and Scopus were searched through to March 2014. The main evaluated maternal outcomes were proportion of patients using insulin and proportion of cesarean delivery; the newborn outcomes were proportion of macrosomia and hypoglycemia and newborn weight. RESULTS: From 1,170 studies, nine RCTs, including 884 women aged 31.5 years (28.7-33.2) with 27.4 weeks (24.1-30.3) of gestation, were eligible. We divided the RCTs according to the type of dietary intervention: low glycemic index (GI) (n = 4; 257 patients), total energy restriction (n = 2; 425 patients), low carbohydrates (n = 2; 182 patients), and others (n = 1; 20 patients). Diet with low GI reduced the proportion of patients who used insulin (relative risk 0.767 [95% CI 0.597, 0.986]; P = 0.039) and the newborn birth weight (weight mean differences -161.9 g [95% CI -246.4, -77.4]; P = 0.000) as compared with control diet. Total restriction and low carbohydrate diets did not change either maternal or newborn outcomes. CONCLUSIONS: A low GI diet was associated with less frequent insulin use and lower birth weight than control diets, suggesting that it is the most appropriate dietary intervention to be prescribed to patients with GDM.

Dietary fat composition and cardiac events in patients with type 2 diabetes.

OBJECTIVE: To evaluate associations of dietary fat composition with the development of cardiac events in patients with type 2 diabetes, without ischemic heart disease who were followed for at least 12 months. METHODS: In this prospective cohort study the usual diet of patients was retrospectively assessed by a 3-day weighed diet record (WDR). Compliance with the WDR technique was assessed by comparing protein intake estimated from 3-day WDR and 24-h urinary nitrogen output. The following were considered cardiac events: myocardial infarction, myocardial revascularization procedures, congestive heart failure, new-onset angina pectoris, and sudden death. RESULTS: A total of 227 patients with type 2 diabetes (aged 59 ± 10 years; 46.0% male), were followed during 4.6 years. In a multivariate Cox regression analysis, the intake of polyunsaturated fatty acids had a protective effect for cardiac events (HR = 0.31, 95% CI: 0.11-0.89; P = 0.03) adjusted for age, gender, duration of diabetes, smoking, compliance with WDR, using hypolipidemic agents, and the presence of hypertension and diabetic nephropathy. When the fat intake was divided into quartiles, the highest intake of α-linolenic acid (>1.25% of energy) was negatively associated with cardiac events (HR = 0.58, 95% CI: 0.39-0.85; P = 0.006), adjusted for the same covariates.. CONCLUSION: In patients with type 2 diabetes without ischemic heart disease, a high intake of polyunsaturated fatty acids, especially alpha linolenic acid, was protective for the development of cardiac events..

Contrasting effects of preexisting hyperglycemia and higher body size on hospital mortality in critically ill patients: a prospective cohort study.

BACKGROUND: Obesity and diabetes mellitus are well-defined risk factors for cardiovascular mortality. The impact of antecedent hyperglycemia and body size on mortality in critical ill patients in intensive care units (ICUs) may vary across their range of values. Therefore, we prospectively analyzed the relationship between in-hospital mortality and preexisting hyperglycemia and body size in critically ill ICU patients to understand how mortality varied among normal, overweight, and obese patients and those with low, intermediate, and high glycated hemoglobin (HbA1c) levels. METHODS: Medical history, weight, height, physiologic variables, and HbA1c were obtained during the first 24 h for patients who were consecutively admitted to the high complexity ICU of Hospital de Clínicas de Porto Alegre, Brazil, from April to August 2011. The relationships between mortality and obesity and antecedent hyperglycemia were prospectively analyzed by cubic spline analysis and a Cox proportional hazards model. RESULTS: The study comprised 199 patients. The overall hospital mortality rate was 43.2% during a median 16 (8-28) days of follow-up. There was a progressive risk of in-hospital mortality with higher HbA1c levels, with the relationship becoming significant at HbA1c >9.3% compared with lower levels (hazard ratio 1.74; 95% confidence interval with Bonferroni correction 1.49-2.80). In contrast, mean body mass index (BMI) was higher in survivors than in nonsurvivors (27.2 kg/m2 ± 7.3 vs. 24.7 kg/m2 ± 5.0 P = 0.031, respectively). Cubic spline analysis showed that these relationships differed nonlinearly through the spectrum of BMI values. In a Cox proportional hazards model adjusted for Acute Physiology and Chronic Health Evaluation II score and HbA1c, the risk of in-hospital mortality progressively decreased with increasing BMI (BMI <20 vs. 20-23.9 kg/m2, P = 0.032; BMI <20 vs. 24-34.9 kg/m2, P = 0.010; BMI <20 vs. ≥35 kg/m2, P = 0.032). CONCLUSIONS: Our findings suggest that significant hyperglycemia prior to ICU admission is a risk factor for in-hospital mortality. Conversely, increasing BMI may confer an advantageous effect against mortality in critical illness independently of previous glycemic control.