Coeliac disease and type 1 diabetes are autoimmune diseases that may share the same initiating environmental factors. In this study, the occurrence of type 1 diabetes associated autoantibodies (GADA and IA-2A) and tissue transglutaminase autoantibodies (TGA) was determined in patients with confirmed viral infections and no signs of type 1 diabetes or coeliac disease. Serum samples from 82 Cuban patients tested positive for PCR and IgG specific to enterovirus (HEV, serotype echovirus 16, 20 samples), Epstein-Barr virus (EBV, 20 samples), cytomegalovirus (CMV, 21 samples), and hepatitis C virus (HCV, 21 samples); and sera from 164 controls negative serologically to EBV, CMV, HCV, and echovirus 16 were enrolled in the study. All subjects were screened for GADA, IA-2A, and TGA. The prevalence of TGA in patients infected with HEV, EBV, CMV, or HCV was 55% (11/20), 25% (5/20), 9.5% (2/21), and 9.5% (2/21), respectively. GADA and IA-2A were found in 15% (3/20) and 25% (5/20) of patients infected with HEV. None of the patients infected by EBV, CMV, and HCV had GADA or IA-2A. All children infected with HEV who were positive for type 1 diabetes-associated autoantibodies were also TGA-positive. None of the sera from uninfected subjects were positive for GADA, IA-2A or TGA. In conclusion, TGA can develop during infection with HEV, EBV, CMV, or HCV, while the emergence of islet cell related autoantibodies is restricted to HEV infections. The findings suggest that HEV may be a shared environmental factor for the development of islet and gut-related autoimmunity.

A possible etiologic role of enteroviruses for type 1 diabetes has been researched for 40 years, but evidence to date is inconclusive. This article summarizes new evidence from Cuban research supporting a role for enteroviruses, both in preclinical stages of autoimmune reactions against pancreatic β cells and at clinical onset, in a population with low type 1 diabetes incidence. Possible pathogenetic mechanisms are also discussed, such as acute cytolytic damage and molecular mimicry. Although direct causal effects of enteroviruses in type 1 diabetes are difficult to demonstrate, arguments supporting their role in type 1 diabetes pathogenesis should not be ignored; and confirmation could contribute to development of more effective preventive strategies.

Objetivos. El objetivo del presente estudio fue determinar el grado de concordancia diagnóstica entre siete definiciones de síndrome metabólico (SM) en un grupo de adultos con sobrepeso y obesos. Material y Métodos. Se estudiaron 350 sujetos con edades comprendidas entre 19 y 70 años que fueron reclutados consecutivamente de una consulta para sujetos con sobrepeso y obesidad. Se emplearon las definiciones de SM según OMS (Organización Mundial de la Salud), EGIR (Grupo Europeo para el estudio de la resistencia a la insulina), NCEP-ATPIII (Panel de Tratamiento de Adultos), AHA/NHLBI (Asociación Americana del Corazón), IDF (Federación Internacional de Diabetes), JIS (Declaración provisional conjunta), así como los criterios de Szabo. La concordancia entre las definiciones fue calculada con el coeficiente Kappa. La resistencia a la insulina (RI) fue evaluada mediante el índice HOMA. Resultados. Según los criterios de Szabo, OMS, EGIR, NCEP-ATPIII, AHA/NHLBI, IDF y la JIS, la frecuencia de SM fue del 74,3%, 42,0%, 46,8%, 56,0%, 52,9%, 58,6% y 58,6%, respectivamente. La concordancia entre los criterios de Szabo y la AHA/NHLBI fue de 0,559, mientras que el coeficiente kappa entre los criterios de Szabo, y el resto de las guías (NCEP-ATPIII, IDF, JIS) fue de 0,612 a 0,657, respectivamente. La concordancia de la OMS con las demás guías fue entre 0,358 y 0,422, pero con la EGIR la concordancia fue de 0,602. La RI se distribuyó de manera similar en todas las guías. Conclusiones. Existe una considerable concordancia entre las guías NCEP-ATPIII, IDF, JIS y el SM según criterios de Szabo. El SM según criterios de Szabo pudiera ser otra alternativa para la pesquisa activa del SM en poblaciones.Palabras claves: Síndrome X metabólico; Prevalencia; Sobrepeso; Obesidad; Resistencia a la insulina (fuente: DeCS BIREME). DIAGNOSTIC CONCORDANCE BETWEEN SEVEN DEFINITIONS OF METABOLIC SYNDROME IN OVERWEIGHT AND OBESE ADULTS ABSTRACTObjectives. The aim of this study was to determine the level of diagnostic concordance between seven definitions of metabolic syndrome (MS) in a group of overweight and obese adults. Materials and Methods. 350 subjects aged from 19 to 70 years were recruited for study from a clinic for overweight and obese subjects. Citar como: Cabrera-Rode E, Stusser B, Cálix W, Orlandi N, Rodriguez J, Cuba-Dueñaz I, et al. Concordancia diagnóstica entre siete definiciones de síndrome metabólico en adultos con sobrepeso y obesidad.

Obex is a dietary supplement to help weight loss. The purpose of this study was to evaluate the effect of Obex in overweight/obese participants with or without impaired fasting glucose. This was an open-label pilot study conducted with 40 overweight and obese subjects, 23-60 years old with a body mass index of 25-44 kg/m (20 participants with impaired fasting glucose [IFG] and 20 with normal glucose levels). Participants received Obex at a dose of one sachet before the two main meals of each day for 3 months. In addition to anthropometric measures and blood pressure (BP), fasting plasma glucose, lipid profile, insulin, creatinine, and uric acid were determined. Insulin resistance (HOMA-IR) and beta-cell function (HOMA-B) were assessed. Three indirect indices were used to calculate insulin sensitivity. Compared to baseline, Obex significantly reduced body weight, body mass index, waist circumference, waist/hip ratio, and waist/height ratio in both groups of participants (p <.05). In individuals without IFG, Obex improved HDL-c (high-density lipoprotein cholesterol) (p <.0001) and lowered BP (p <.05). After 3 months of Obex, subjects with IFG showed a reduction in fasting glucose concentrations (p <.0001). Compared to baseline, this group also showed improved insulin sensitivity and HDL-c (p <.05). In conclusion, the consumption of Obex contributed to weight reduction, improved glucose tolerance and insulin sensitivity, as well as HDL-c, and appears to be safe in overweight/obese adults with impaired fasting glucose. Obex may be beneficial for weight loss, indicating that further studies are required.

Type 1 diabetes (T1D) results from the interaction of genetic and environmental factors. Previous studies indicate an association between detection of Enterovirus (EV) genome in blood and the clinical onset of T1D. Insulin resistance can also represent a risk factor for progression to clinically overt T1D. This study aimed at evaluating whether there is association between both EV infection and insulin resistance with islet autoantibodies in first-degree relatives of persons with type 1 diabetes. We collected sera from 94 first-degree relatives with (32) or without (64) islet cell antibodies (ICA) from the Cuban T1D prediction program. Blood glucose and insulin concentrations were determined. Antibodies to GAD65 and IA-2 were determined by radioimmunoassay. Insulin resistance was estimated by the homeostasis model assessment (HOMA-IR). EV-RNA was detected in serum using a highly sensitive reverse transcriptase-polymerase chain reaction method. The occurrence of EV-RNA was higher in ICA-positive relatives than in ICA-negative ones [15.6% (5/32) vs. 1.6% (1/62), P = 0.016]. GAD65 autoantibodies were more frequent in subjects with insulin resistance [34.5% (10/29) vs. 13.9% (9/65), P = 0.028] as defined by the HOMA-IR value. GAD65 autoantibodies also positively correlated with HOMA-IR (r.bis = 0.28, P < 0.01). IA-2 autoantibodies did correlate neither with EV-RNA nor with insulin resistance. There was no association between the presence of EV-RNA and insulin resistance. Our data suggest that enterovirus infection and insulin resistance are two independent events associated with ICA and GAD65 autoantibodies, respectively. These observations support the multifactorial nature of T1D.

Background Obex® may be helpful in reducing body weight and fat. The current study was carried out to evaluate the efficacy and safety of Obex® in the treatment of overweight and obese subjects. Methods A double-blind, randomised, controlled phase III clinical trial was conducted involving 160 overweight and obese subjects (BMI ≥ 25.0 and < 40 kg/m2) aged 20 to 60 years, who received Obex® (n = 80) and placebo (n = 80) plus non-pharmacological treatment (physical activity and nutritional counseling). One sachet of Obex® or placebo were administered before the two main meals each day for 6 months. In addition to anthropometric measurements and blood pressure, fasting plasma and 2 h glucose levels during the oral glucose tolerance test, lipid profile, insulin, liver enzymes, creatinine, and uric acid (UA) were determined, insulin resistance (HOMA-IR) beta-cell function (HOMA-β) were assessed and insulin sensitivity (IS) was calculated with three indirect indexes. Results After 3 months of Obex®, 48.3% of the participants (28/58) achieved complete success in reducing both weight and waist circumference by greater than or equal to 5% from baseline, as opposed to 26.0% (13/50) of individuals receiving placebo (p = 0.022). Compared to baseline, at 6 months no differences were found between the groups concerning anthropometric and biochemical measurements, except for high-density lipoprotein cholesterol (HDL-c) levels, which were higher in subjects receiving Obex® compared to those receiving placebo (p = 0.030). After 6 months of treatment, both groups showed reduced cholesterol and triglyceride levels (p < 0.012) compared to baseline value. However, only those intake Obex® showed reduced insulin concentrations and HOMA-IR, improved IS (p < 0.05), and decreased creatinine and UA levels (p < 0.005). Conclusions The consumption of Obex® together with lifestyle changes increased HDL-c, contributed to a rapid reduction of weight and waist circumference, as well as improved insulin homeostasis, which did not occur in the placebo group, and appears to be safe as an adjunct at conventional obesity treatment. Trial registration Clinical trial protocol was registered in the Cuban public registry of clinical trials under code RPCEC00000267 on 17/04/2018 and also registered in the international registry of clinical trials, ClinicalTrials.gov, under code: NCT03541005 on 30/05/2018.

The objective of the present study was to determine if the hypertension-abdominal obesity phenotype (HTAOP) is the most useful binomial to identify people with metabolic syndrome (MS). Observational, descriptive and cross-sectional study that included 350 subjects with excess weight between 19 and 70 years old, who were consecutively recruited in a consultation enabled for this investigation. The definition of the joint provisional declaration was used as a diagnostic criterion for MS. In addition, the HTAOP, the hypertriglyceridemia-abdominal obesity phenotype (HGAOP) and the hyperglycaemia-abdominal obesity phenotype (HGLAOP) were also studied. The concordance between the MS criteria and the phenotypes studied was estimated with the kappa coefficient; the sensitivity and specificity of phenotypes to identify people with MS were also calculated. The frequency of HTA-OP was 76.9% (269/350) and the frequency of MS was 69.1% (242/350), followed by the HGAOP (28.0%) and the HGLAOP (20.9%). The HTAOP showed high sensitivity (90.5%) and moderate concordance (0.475) to detect people with MS. The high sensitivity and moderate concordance of the HTAOP to identify people with MS, as well as the simplicity in its determination, make it a useful option for detecting people with MS.

We conducted a phase I-IIa, randomized, monocentric, double-blind, placebo-controlled clinical trial to evaluate the safety and impact of the combination treatment of Itolizumab and insulin on preserving beta cell function in adults with recent-onset type 1 diabetes. Twelve patients were randomly assigned to three treatment groups, each receiving a different Itolizumab dose (0.4/0.8/1.6 mg/kg body weight, respectively) and a placebo group. All patients received concomitant intensive multiple-dose insulin therapy. Endogenous insulin secretion was assessed by the measurement of C-peptide during the mixed-meal tolerance test. No serious adverse events were reported. No changes in the total daily insulin doses, glycated hemoglobin levels, and stimulated C-peptide were observed between the Itolizumab and placebo groups at 52 weeks. A significant decrease in stimulated C-peptide was observed during the follow-up period (p = 0.012). One subject treated with 1.6 mg of Itolizumab showed a marked increase in the levels of stimulated C-peptide three years after completion of the trial. Taken together, this is the first study to demonstrate that combination treatment with Itolizumab and insulin is safe in humans and does not affect the residual function of beta cells up to 52 weeks. The findings from our study show preliminary evidence that high doses of Itolizumab could potentially arrest the loss of beta cell function in the long term. Further studies with a longer follow-up and larger numbers of patients are envisaged to assess the effect with high dose Itolizumab.