Recently, the absence of metabolic effects from nonnutritive sweeteners has been questioned. The aim of this study was to evaluate the effects of sucralose consumption on glucose metabolism variables. We performed a randomized controlled trial involving healthy subjects without comorbidities and with a low habitual consumption of nonnutritive sweeteners (n = 33/group). The intervention consisted of sucralose consumption as 15% of Acceptable Daily Intake every day for 14 d using commercial sachets. The control group followed the same procedures without any intervention. The glucose metabolism variables (insulin sensitivity, acute insulin response to glucose, disposition index, and glucose effectiveness) were evaluated by using a 3-h modified intravenous-glucose-tolerance test before and after the intervention period. Individuals assigned to sucralose consumption showed a significant decrease in insulin sensitivity with a median (IQR) percentage change of -17.7% (-29.3% to -1.0%) in comparison to -2.8% (-30.7% to 40.6%) in the control group (P= 0.04). An increased acute insulin response to glucose from 577 mU · L-1· min (350-1040 mU · L-1· min) to 671 mU · L-1· min (376-1010 mU · L-1· min) (P = 0.04) was observed in the sucralose group for participants with adequate adherence. Sucralose may have effects on glucose metabolism, and our study complements findings previously reported in other trials. Further studies are needed to confirm the decrease in insulin sensitivity and to explore the mechanisms for these metabolic alterations. This trial was registered at www.clinicaltrials.gov as NCT02589002.
OBJECTIVE—To compare the carotid artery intima-media thickness in Hispanic pediatric type 1 diabetic patients against that in healthy control subjects matched for age, sex, height, and BMI. RESEARCH DESIGN AND METHODS—The evaluation consisted of anthropometric measurements, biochemical parameters, and a carotid Doppler and real-time ultrasound, in which carotid artery intima-media thickness (cIMT), peak systolic velocity, and end diastolic velocity were measured using standardized procedures. RESULTS—A total of 52 diabetic patients and 47 control subjects were included. No significant differences existed in the characteristics between case and control subjects (mean age 11.8 ± 3.1 vs. 11.8 ± 2.8 years, weight 42.2 ± 15.3 vs. 44.2 ± 14.4 kg, height 1.45 ± 0.15 vs. 1.47 ± 0.15 m, BMI 19.3 ± 3.2 vs. 19.9 ± 4.4 kg/m2, systolic blood pressure 99.1 ± 9.9 vs. 99.6 ± 9 mmHg, and diastolic blood pressure 63 ± 6.4 vs. 62.0 ± 5.7 mmHg, respectively). The mean duration of diabetes was 4.8 ± 3.2 years (range 6–144 months), and the mean A1C was 8.6 ± 1.6%. A significantly higher cIMT was found in the patients with type 1 diabetes (0.463 ± 0.04 vs. 0.441 ± 0.04 mm; P = 0.001). In contrast, both peak systolic velocity (107.1 ± 22.8 vs. 119.3 ± 19.2, P < 0.005) and end diastolic velocity (28.4 ± 6.0 vs. 33.0 ± 7.0, P < 0.001) were higher in the control subjects. CONCLUSIONS—Type 1 diabetes is associated with higher cIMT and decreased flow velocities in a Hispanic pediatric population.
9 December 2021 in The Journal of Clinical Endocrinology & Metabolism
Primary hyperlipidemias include a heterogeneous set of monogenic and polygenic conditions characterized by a strong family aggregation, severe forms of hypercholesterolemia and/or hypertriglyceridemia, appearance early on life, and a high risk of cardiovascular events and/or recurrent pancreatitis. In real life, a small proportion of the primary hyperlipidemia cases is recognized and treated properly. Our goal is to present an update of current and upcoming therapies for patients with primary hyperlipidemia. Recently, new lipid-lowering medications have obtained authorization from the U.S. Food and Drug Administration and the European Medicines Agency. These drugs target metabolic pathways, including (adenosine 5′-triphosphates)-citrate lyase (bempedoic acid), proprotein convertase subtilisin/kexin 9 (inclisiran), apolipoprotein CIII (volanesorsen), and angiopoietin-like 3 (volanesorsen), that have additive effects with the actions of the currently available therapies (i.e., statins, ezetimibe or fibrates). We discuss the potential clinical indications for the novel medications. To conclude, the addition of these new medications to the therapeutic options for primary hyperlipidemia patients may increase the likelihood of achieving the treatment targets. Also, it could be a safer alternative for patients with side effects for the currently available drugs.
Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease.
1 April 2017 in European Journal of Gastroenterology & Hepatology
Objective: The aim of this study is to determine whether insulin resistance is associated with elevation of transaminases levels and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio in normal-weight healthy young adults. Participants and methods: Apparently healthy nonpregnant women and men, aged 18–23 years, were enrolled in a cross-sectional study. According to the homeostasis model assessment of insulin resistance, the participants were allocated into groups of patients with (>2.5) and without (≤2.5) insulin resistance. Normal weight was defined by BMI of at least 18.5 and less than 25.0 kg/m2. A multiple logistic regression analysis was carried out to determine the association between insulin resistance and elevated transaminases and AST/ALT ratio of 1 or less. Results: A total of 1732 young adults were enrolled and allocated into groups with (n=287) and without (n=1445) insulin resistance. The prevalence of insulin resistance was 16.6% in the overall population. The multivariate logistic regression analysis adjusted by age, sex, waist circumference, and BMI indicated that the odds ratio (OR) between insulin resistance and elevated ALT concentrations is 1.65 [95% confidence interval (CI): 1.04–2.62, P=0.03], for AST/ALT ratio lower than 1 OR is 1.69 (95% CI: 1.27–2.26, P<0.001), and for elevated AST levels OR is 1.31 (95% CI: 0.71–2.43, P=0.377). Conclusion: The results of the present study suggest that insulin resistance is significantly associated with elevated ALT levels and AST/ALT ratio of lower than 1, but not with elevated AST levels.