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.
Antecedentes: las enfermedades del sistema endocrino pueden afectar la sexualidad por sus efectos hormonales, las comorbilidades asociadas y su impacto psicosocial, tema poco estudiado desde las perspectivas de personas con estas enfermedades. Objetivos: se realizó un estudio cualitativo dirigido a comprender las experiencias sexuales de mujeres y varones con enfermedades endocrinas que producen cambios en la apariencia física. Método: se estructuró un diseño de estudio analítico-interpretativo. Participaron 68 personas entre 20 y 45 años de edad, atendidos en el Instituto Nacional de Endocrinología, La Habana, Cuba. Los instrumentos de recolección de la información utilizados fueron una planilla de datos generales, una guía de entrevista en profundidad y dos pruebas psicológicas proyectivas. Los aspectos éticos fueron considerados. Resultados: de las entrevistas en profundidad, emergieron 4 temas: 1) la expresión multidimensional de la enfermedad, 2) enfermedad y áreas de vida, 3) ejercicio de la sexualidad con la enfermedad, y 4) estrategias de afrontamiento en el área sexual; vinculados con los significados expresados sobre la salud, el cuerpo, el género y la sexualidad. Conclusiones: las/los participantes contextualizaron sus experiencias sexuales en el impacto biopsicosocial de la enfermedad. La reproducción o cuestionamiento de los significados expresados influyó en la calidad de sus experiencias sexuales. El estudio mostró que esta constituye un área de vulnerabilidad para la salud integral de las/los participantes.
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.
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