Early triglyceride and glucose index as a risk marker for gestational diabetes mellitus.

OBJECTIVE: To assess the risk of gestational diabetes mellitus (GDM) according to the triglyceride and glucose (TyG) index values during the first trimester of pregnancy in Latin American women. METHODS: Pregnant women were enrolled at their first prenatal visit at the Obstetric Division in the University Hospital "Dr. José E. González". Triglycerides and fasting plasma glucose (FPG) were collected to determine the TyG index. GDM diagnosis was performed by a single-step 2-hour 75-g oral glucose tolerance test. Generalized linear models were used to determine risk ratios; pregnancy outcomes at delivery were collected from the hospital medical records. RESULTS: A total of 164 pregnant women were included. GDM was present in 29 (17.7%) women. No significant differences in age, first-trimester body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters), family history of diabetes, and TyG index were observed between GDM cases and the reference group without GDM. The adjusted analysis showed no association between TyG and GDM (risk ratio [RR] 1.03, 95% confidence interval [CI] 0.57-1.88]). Higher TyG index values between women with and without a diagnosis of GDM in the second trimester were observed. No significant differences were identified in pregnancy outcomes, although a trend was observed for hyperbilirubinemia in women with first-trimester TyG index values greater than 8.7. CONCLUSIONS: Our findings do not support the use of the TyG index for GDM prediction in Latin American women.

Diagnostic accuracy of the triglyceride-glucose index for gestational diabetes screening: a practical approach.

The oral glucose tolerance test (OGTT) remains as the gold standard to diagnose gestational diabetes mellitus (GDM); however, this test may be inconvenient and costly. Hence, other easy to perform and accurate diagnostic alternatives would be valuable for maternal care. The objective of the study was to assess the diagnostic performance of the TyG index to screen for GDM at 24-28 of pregnancy. A total of 140 pregnant women who received the one-step 2 h 75 g OGTT were included. Overall GDM prevalence was 27.1% according to IADSPG criteria. The mean TyG index value in the GDM group was significantly higher than the TyG index for the no GDM group (4.88 ± 0.70 versus 4.68 ± 0.19, p<.001). A sensitivity of 89% [95% CI 0.75-0.97] and a specificity of 50% [95% CI 0.39-0.60)], accompanied by a high negative predictive value of 93% was observed. No differences were found in maternal and neonatal outcomes irrespective of the TyG cutoff value for GDM. According to our results, the TyG index may be a highly sensitive and easy to perform screening test for GDM.

Diagnostic Accuracy of the Triglyceride and Glucose Index for Insulin Resistance: A Systematic Review.

Introduction. The triglyceride and glucose (TyG) index has been described as a biochemical marker of insulin resistance (IR); however, its diagnostic accuracy remains uncertain. OBJECTIVE: To summarize the evidence assessing the diagnostic accuracy of the TyG index regarding IR. METHODS: A comprehensive search in MEDLINE, EMBASE, Web of Science, and Scopus was performed without any language restriction. Studies assessing the diagnostic accuracy of the TyG index against the hyperinsulinemic-euglycemic clamp (HIEC) or any other IR biochemical were assessed independently and in duplicate. Diagnostic accuracy measures (sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios) were extracted independently and in duplicate. The QUADAS-2 tool was used to assess the risk of bias of independent studies. RESULTS: We identified 15 eligible studies with 69,922 participants and an overall quality of low to moderate. The TyG index was evaluated by HIEC and HOMA as reference tests. The highest achieved sensitivity was 96% using HIEC, and the highest specificity was of 99% using HOMA-IR, with a cutoff value of 4.68. AUC values varied from 0.59 to 0.88. Cutoff values for IR were variable between studies, limiting its comparability. CONCLUSION: In this systematic review, we found moderate-to-low quality evidence about the usefulness of the TyG index as a surrogate biochemical marker of IR. Due to the lack of a standardized IR definition and heterogeneity between studies, further validation and standardized cutoff values are needed to be used in clinical practice.

Acanthosis Nigricans in the Knuckles of Infants: A Novel Clinical Marker of High Metabolic Risk.

INTRODUCTION: Acanthosis nigricans (AN) is an early clinical sign of insulin resistance (IR) primarily in adults. The prevalence and association of AN and IR in infants, however, remains uncertain. We aimed to describe the prevalence of AN and its association with IR in a group of Latin-American infants. METHODS: We studied a random sample of 227 healthy infants between 9 and 24 months of age. After a complete clinical history was obtained and a physical examination was performed, fasting plasma glucose and serum insulin were measured. Three blinded evaluators assessed AN in each patient. Infants with AN were categorized as cases. The HOMA-IR index cutoffs of ≥ 90th and ≥ 95th percentiles were considered IR. RESULTS: There were 49 infants with AN (21.6%) (cases) and 178 without AN (78.4%) (controls). Cases had a significantly higher mean serum insulin, fasting plasma glucose, and HOMA-IR levels of 3.67 ± 2.56 µU/ml vs. 2.42 ± 1.45 µU/ml, P = 0.005; 84.2 ± 12.6 mg/dL vs. 77 ± SD 9.9 mg/dL, P ≤ 0.001; HOMA-IR 0.77 ± 0.54 vs. 0.46 ± 0.28, P ≤ 0.001, respectively. More cases than controls presented HOMA-IR levels ≥ 95th percentile (cases 18.4%; controls 0.5%, P ≤ 0.001) and ≥ 90th percentile (cases 32.7%; controls 1.6%, P ≤ 0.001). AN in the knuckles had a high sensitivity and a negative predictive value (NPV) for detecting patients with HOMA-IR levels above the 95th percentile (sensitivity 90%; NPV 99.4%) and above the 90th percentile (sensitivity 84.2%; NPV 98.3%). CONCLUSION: AN in the knuckles is a prevalent, non-invasive, costless, and reliable screening clinical tool that can be used for early detection of infants with IR and a high metabolic risk.

Hypertriglyceridemia and Its Association with HbA1c Test: A Prospective In Vivo Controlled Study.

BACKGROUND: Hypertriglyceridemia and hyperglycemia coexist in 30-60% of patients with diabetes. The impact of hypertriglyceridemia regarding HbA1c assay reliability remains uncertain. Therefore, we conducted a prospective in vivo controlled study with the aim of defining the association between triglyceride levels and HbA1c. METHODS: A total of 44 patients with an index-hospital admission diagnosis of diabetic ketoacidosis or hypertriglyceridemia-induced pancreatitis, as a model for acute elevation of triglycerides, were recruited. Blood samples were drawn for the measurement of HbA1c, triglycerides, glucose, and hemoglobin at baseline and subsequently 24 and 48 hours after admission. HbA1c analysis was performed with high-performance liquid chromatography Bio-Rad D10 (NGSP approved). RESULTS: All patients completed the study protocol. A difference between mean triglycerides from day 0 (baseline) to day 2 of 1567.2 mg/dL was observed. We found a difference between mean serum HbA1c from days 0 to 2 of 0.09% [1 mmol/mol] (p = 0.004). Moreover, a weak correlation between the mean difference of HbA1c and triglycerides from baseline to day 2 was found to be statistically significant (r = 0.256, p = 0.015). None of these findings, however, are clinically significant. CONCLUSION: Triglycerides do not impair the interpretation of HbA1c assay. Patients and clinicians can now be confident that hypertriglyceridemia is not an important factor when interpreting HbA1c results.

Participants' awareness of ethical compliance, safety and protection during participation in pharmaceutical industry clinical trials: a controlled survey.

BACKGROUND: The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials (ISRT) on ethical, safety, and protection topics. METHODS: A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT (cases) as well as non-participants (controls) with one of four chronic diseases, were asked to complete the survey which focused on ethical compliance and protection issues of ISRT, and the perception of participating in a trial. RESULTS: A total of 604 cases and 604 controls were surveyed. Cases significantly answered that ethics committees are aware of what is happening in studies (50.5% vs. 33.8%, P = ≤ 0.001), and that medical care of industry-sponsored research trials is better than their usual medical care (77.2% vs. 38.2%, P = < 0.001). The same proportion of cases and controls thought patients must receive economical reimbursement for participating in a research study (49.5% vs. 53.1%, P = 0.205). The informed consent of the pharmaceutical clinical trial was fully read by 90.4% of the cases. Most cases were satisfied or very satisfied with their overall study participation (35.6 and 62.3%, respectively). CONCLUSION: Previous and current participants of industry-sponsored research trials have a more positive attitude towards ethics committees, the quality of medical care of the research trials, and the main purpose of economical reimbursements, when compared to non-participants.

Systematic review and meta-analysis of the effect of SGLT-2 inhibitors on microvascular outcomes in patients with type 2 diabetes: a review protocol.

INTRODUCTION: Sodium glucose cotransporter 2 (SGLT-2) inhibitors are a relatively new drug-class of glucose-lowering medications. Several trials and systematic reviews have demonstrated their beneficial effect on some macrovascular outcomes. Their effect on microvascular outcomes has been reported as positive in several trials, however, their effect remains uncertain. Therefore, we report the protocol of a systematic review and meta-analysis aimed at determining the effect of SGLT-2 inhibitors regarding patient-important and surrogate microvascular outcomes in patients with type 2 diabetes. METHODS AND ANALYSIS: A comprehensive search will be conducted to find eligible articles from each database's earliest inception to November 2017. These databases will include Ovid, MEDLINE, EMBASE, Web of Science, and Scopus. We will search for randomized controlled trials (RCTs) that compare any of the SGLT-2 inhibitors with any other active treatment or placebo assessing microvascular outcomes in either their primary or secondary outcomes. Reviewers working independently and in duplicate will review all abstracts, and full-text manuscripts for eligibility, and will systematically extract the data and will assess the risk of bias in the included studies. Random-effects models will also be used. ETHICS AND DISSEMINATION: The results of the systematic review will be disseminated via publication in a peer-reviewed journal regardless of outcome and will be presented at relevant conferences. The data we will use do not include individual patient data, so ethical approval is not required PROSPERO REGISTRATION NUMBER: CRD42017076460.